§1010.5. Exemptions for products intended for United States Government use. — Inbound Citations

(22) Data and information about an electronic product submitted as part of the procedures for granting, amending, or extending an exemption from a radiation safety performance standard, as described in § 1010.5.

(19) Data and information regarding an electronic product submitted as part of the procedures for granting, amending, or extending an exemption from a radiation safety performance standard, as described in § 1010.5.

(22) Data and information regarding an electronic product submitted as part of the procedures for granting, amending, or extending an exemption from any electronic product performance standard, as described in § 1010.5.

(c) If you are submitting an application for exemption, or for amendment or extension thereof, you must submit two copies (original and redacted version) for confidential petitions to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Otherwise, only one copy is necessary. For an exemption under the criteria prescribed in paragraph (a)(1) of this section, the application shall include the information prescribed in paragraphs (c)(1) through (13) of this section. For an exemption under the criteria prescribed in paragraph (a)(2) of this section, the application shall include the information prescribed in paragraphs (c)(3) through (13) of this section. An application for exemption, or for amendment or extension thereof, and correspondence relating to such application shall be made available for public disclosure in Dockets Management Staff, except for confidential or proprietary information submitted in accordance with part 20 of this chapter. Information classified for reasons of national security shall not be included in the application. Except as indicated in this paragraph (c), the application for exemption shall include the following:

(1) The procurement specifications for the product or class of products that govern emissions of electronic product radiation.

(2) Evidence that the product or class of products is of a type used solely or predominantly by departments or agencies of the United States.

(3) Evidence that such product or class of products is intended for use by a department or agency of the United States.

(5) An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use.

(6) A description of the manner in which it is proposed that the product or class of products shall deviate from the requirements of the applicable standard.

(8) An explanation of how means of radiation protection will be provided where the product or class of products deviates from the requirements of the applicable standard.

(9) The period of time it is desired that the exemption be in effect, and, if appropriate, the number of units to be manufactured under the exemption.

(11) The name, address, and telephone number of the appropriate office of the United States department or agency purchasing the product or class of products.

(12) Such other information required by regulation or by the Director, Center for Devices and Radiological Health, to evaluate and act on the application. Where such information includes nonclinical laboratory studies, the information shall include, with respect to each nonclinical study, either a statement that each study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a statement that describes in detail all differences between the practices used in the study and those required in the regulations. When such information includes clinical investigations involving human subjects, the information shall include, with respect to each clinical investigation, either a statement that each investigation was conducted in compliance with the requirements set forth in part 56 of this chapter, or a statement that the investigation is not subject to such requirements in accordance with § 56.104 or § 56.105 and a statement that each investigation was conducted in compliance with the requirements set forth in part 50 of this chapter.

(13) With respect to each nonclinical laboratory study contained in the application, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

(c) If you are submitting an application for exemption, or for amendment or extension thereof, you must submit two copies (original and redacted version) for confidential petitions to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Otherwise, only one copy is necessary. For an exemption under the criteria prescribed in paragraph (a)(1) of this section, the application shall include the information prescribed in paragraphs (c)(1) through (13) of this section. For an exemption under the criteria prescribed in paragraph (a)(2) of this section, the application shall include the information prescribed in paragraphs (c)(3) through (13) of this section. An application for exemption, or for amendment or extension thereof, and correspondence relating to such application shall be made available for public disclosure in Dockets Management Staff, except for confidential or proprietary information submitted in accordance with part 20 of this chapter. Information classified for reasons of national security shall not be included in the application. Except as indicated in this paragraph (c), the application for exemption shall include the following:

(1) The procurement specifications for the product or class of products that govern emissions of electronic product radiation.

(2) Evidence that the product or class of products is of a type used solely or predominantly by departments or agencies of the United States.

(3) Evidence that such product or class of products is intended for use by a department or agency of the United States.

(5) An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use.

(6) A description of the manner in which it is proposed that the product or class of products shall deviate from the requirements of the applicable standard.

(8) An explanation of how means of radiation protection will be provided where the product or class of products deviates from the requirements of the applicable standard.

(9) The period of time it is desired that the exemption be in effect, and, if appropriate, the number of units to be manufactured under the exemption.

(11) The name, address, and telephone number of the appropriate office of the United States department or agency purchasing the product or class of products.

(12) Such other information required by regulation or by the Director, Center for Devices and Radiological Health, to evaluate and act on the application. Where such information includes nonclinical laboratory studies, the information shall include, with respect to each nonclinical study, either a statement that each study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a statement that describes in detail all differences between the practices used in the study and those required in the regulations. When such information includes clinical investigations involving human subjects, the information shall include, with respect to each clinical investigation, either a statement that each investigation was conducted in compliance with the requirements set forth in part 56 of this chapter, or a statement that the investigation is not subject to such requirements in accordance with § 56.104 or § 56.105 and a statement that each investigation was conducted in compliance with the requirements set forth in part 50 of this chapter.

(13) With respect to each nonclinical laboratory study contained in the application, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

(c) If you are submitting an application for exemption, or for amendment or extension thereof, you must submit two copies (original and redacted version) for confidential petitions to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Otherwise, only one copy is necessary. For an exemption under the criteria prescribed in paragraph (a)(1) of this section, the application shall include the information prescribed in paragraphs (c)(1) through (13) of this section. For an exemption under the criteria prescribed in paragraph (a)(2) of this section, the application shall include the information prescribed in paragraphs (c)(3) through (13) of this section. An application for exemption, or for amendment or extension thereof, and correspondence relating to such application shall be made available for public disclosure in Dockets Management Staff, except for confidential or proprietary information submitted in accordance with part 20 of this chapter. Information classified for reasons of national security shall not be included in the application. Except as indicated in this paragraph (c), the application for exemption shall include the following:

(1) The procurement specifications for the product or class of products that govern emissions of electronic product radiation.

(2) Evidence that the product or class of products is of a type used solely or predominantly by departments or agencies of the United States.

(3) Evidence that such product or class of products is intended for use by a department or agency of the United States.

(5) An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use.

(6) A description of the manner in which it is proposed that the product or class of products shall deviate from the requirements of the applicable standard.

(8) An explanation of how means of radiation protection will be provided where the product or class of products deviates from the requirements of the applicable standard.

(9) The period of time it is desired that the exemption be in effect, and, if appropriate, the number of units to be manufactured under the exemption.

(11) The name, address, and telephone number of the appropriate office of the United States department or agency purchasing the product or class of products.

(12) Such other information required by regulation or by the Director, Center for Devices and Radiological Health, to evaluate and act on the application. Where such information includes nonclinical laboratory studies, the information shall include, with respect to each nonclinical study, either a statement that each study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a statement that describes in detail all differences between the practices used in the study and those required in the regulations. When such information includes clinical investigations involving human subjects, the information shall include, with respect to each clinical investigation, either a statement that each investigation was conducted in compliance with the requirements set forth in part 56 of this chapter, or a statement that the investigation is not subject to such requirements in accordance with § 56.104 or § 56.105 and a statement that each investigation was conducted in compliance with the requirements set forth in part 50 of this chapter.

(13) With respect to each nonclinical laboratory study contained in the application, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

(c) If you are submitting an application for exemption, or for amendment or extension thereof, you must submit two copies (original and redacted version) for confidential petitions to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Otherwise, only one copy is necessary. For an exemption under the criteria prescribed in paragraph (a)(1) of this section, the application shall include the information prescribed in paragraphs (c)(1) through (13) of this section. For an exemption under the criteria prescribed in paragraph (a)(2) of this section, the application shall include the information prescribed in paragraphs (c)(3) through (13) of this section. An application for exemption, or for amendment or extension thereof, and correspondence relating to such application shall be made available for public disclosure in Dockets Management Staff, except for confidential or proprietary information submitted in accordance with part 20 of this chapter. Information classified for reasons of national security shall not be included in the application. Except as indicated in this paragraph (c), the application for exemption shall include the following:

(1) The procurement specifications for the product or class of products that govern emissions of electronic product radiation.

(2) Evidence that the product or class of products is of a type used solely or predominantly by departments or agencies of the United States.

(3) Evidence that such product or class of products is intended for use by a department or agency of the United States.

(5) An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use.

(6) A description of the manner in which it is proposed that the product or class of products shall deviate from the requirements of the applicable standard.

(8) An explanation of how means of radiation protection will be provided where the product or class of products deviates from the requirements of the applicable standard.

(9) The period of time it is desired that the exemption be in effect, and, if appropriate, the number of units to be manufactured under the exemption.

(11) The name, address, and telephone number of the appropriate office of the United States department or agency purchasing the product or class of products.

(12) Such other information required by regulation or by the Director, Center for Devices and Radiological Health, to evaluate and act on the application. Where such information includes nonclinical laboratory studies, the information shall include, with respect to each nonclinical study, either a statement that each study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a statement that describes in detail all differences between the practices used in the study and those required in the regulations. When such information includes clinical investigations involving human subjects, the information shall include, with respect to each clinical investigation, either a statement that each investigation was conducted in compliance with the requirements set forth in part 56 of this chapter, or a statement that the investigation is not subject to such requirements in accordance with § 56.104 or § 56.105 and a statement that each investigation was conducted in compliance with the requirements set forth in part 50 of this chapter.

(13) With respect to each nonclinical laboratory study contained in the application, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

(c) If you are submitting an application for exemption, or for amendment or extension thereof, you must submit two copies (original and redacted version) for confidential petitions to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Otherwise, only one copy is necessary. For an exemption under the criteria prescribed in paragraph (a)(1) of this section, the application shall include the information prescribed in paragraphs (c)(1) through (13) of this section. For an exemption under the criteria prescribed in paragraph (a)(2) of this section, the application shall include the information prescribed in paragraphs (c)(3) through (13) of this section. An application for exemption, or for amendment or extension thereof, and correspondence relating to such application shall be made available for public disclosure in Dockets Management Staff, except for confidential or proprietary information submitted in accordance with part 20 of this chapter. Information classified for reasons of national security shall not be included in the application. Except as indicated in this paragraph (c), the application for exemption shall include the following:

(1) The procurement specifications for the product or class of products that govern emissions of electronic product radiation.

(2) Evidence that the product or class of products is of a type used solely or predominantly by departments or agencies of the United States.

(3) Evidence that such product or class of products is intended for use by a department or agency of the United States.

(5) An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use.

(6) A description of the manner in which it is proposed that the product or class of products shall deviate from the requirements of the applicable standard.

(8) An explanation of how means of radiation protection will be provided where the product or class of products deviates from the requirements of the applicable standard.

(9) The period of time it is desired that the exemption be in effect, and, if appropriate, the number of units to be manufactured under the exemption.

(11) The name, address, and telephone number of the appropriate office of the United States department or agency purchasing the product or class of products.

(12) Such other information required by regulation or by the Director, Center for Devices and Radiological Health, to evaluate and act on the application. Where such information includes nonclinical laboratory studies, the information shall include, with respect to each nonclinical study, either a statement that each study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a statement that describes in detail all differences between the practices used in the study and those required in the regulations. When such information includes clinical investigations involving human subjects, the information shall include, with respect to each clinical investigation, either a statement that each investigation was conducted in compliance with the requirements set forth in part 56 of this chapter, or a statement that the investigation is not subject to such requirements in accordance with § 56.104 or § 56.105 and a statement that each investigation was conducted in compliance with the requirements set forth in part 50 of this chapter.

(13) With respect to each nonclinical laboratory study contained in the application, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

(c) If you are submitting an application for exemption, or for amendment or extension thereof, you must submit two copies (original and redacted version) for confidential petitions to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Otherwise, only one copy is necessary. For an exemption under the criteria prescribed in paragraph (a)(1) of this section, the application shall include the information prescribed in paragraphs (c)(1) through (13) of this section. For an exemption under the criteria prescribed in paragraph (a)(2) of this section, the application shall include the information prescribed in paragraphs (c)(3) through (13) of this section. An application for exemption, or for amendment or extension thereof, and correspondence relating to such application shall be made available for public disclosure in Dockets Management Staff, except for confidential or proprietary information submitted in accordance with part 20 of this chapter. Information classified for reasons of national security shall not be included in the application. Except as indicated in this paragraph (c), the application for exemption shall include the following:

(1) The procurement specifications for the product or class of products that govern emissions of electronic product radiation.

(2) Evidence that the product or class of products is of a type used solely or predominantly by departments or agencies of the United States.

(3) Evidence that such product or class of products is intended for use by a department or agency of the United States.

(5) An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use.

(6) A description of the manner in which it is proposed that the product or class of products shall deviate from the requirements of the applicable standard.

(8) An explanation of how means of radiation protection will be provided where the product or class of products deviates from the requirements of the applicable standard.

(9) The period of time it is desired that the exemption be in effect, and, if appropriate, the number of units to be manufactured under the exemption.

(11) The name, address, and telephone number of the appropriate office of the United States department or agency purchasing the product or class of products.

(12) Such other information required by regulation or by the Director, Center for Devices and Radiological Health, to evaluate and act on the application. Where such information includes nonclinical laboratory studies, the information shall include, with respect to each nonclinical study, either a statement that each study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a statement that describes in detail all differences between the practices used in the study and those required in the regulations. When such information includes clinical investigations involving human subjects, the information shall include, with respect to each clinical investigation, either a statement that each investigation was conducted in compliance with the requirements set forth in part 56 of this chapter, or a statement that the investigation is not subject to such requirements in accordance with § 56.104 or § 56.105 and a statement that each investigation was conducted in compliance with the requirements set forth in part 50 of this chapter.

(13) With respect to each nonclinical laboratory study contained in the application, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

(c) If you are submitting an application for exemption, or for amendment or extension thereof, you must submit two copies (original and redacted version) for confidential petitions to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Otherwise, only one copy is necessary. For an exemption under the criteria prescribed in paragraph (a)(1) of this section, the application shall include the information prescribed in paragraphs (c)(1) through (13) of this section. For an exemption under the criteria prescribed in paragraph (a)(2) of this section, the application shall include the information prescribed in paragraphs (c)(3) through (13) of this section. An application for exemption, or for amendment or extension thereof, and correspondence relating to such application shall be made available for public disclosure in Dockets Management Staff, except for confidential or proprietary information submitted in accordance with part 20 of this chapter. Information classified for reasons of national security shall not be included in the application. Except as indicated in this paragraph (c), the application for exemption shall include the following:

(1) The procurement specifications for the product or class of products that govern emissions of electronic product radiation.

(2) Evidence that the product or class of products is of a type used solely or predominantly by departments or agencies of the United States.

(3) Evidence that such product or class of products is intended for use by a department or agency of the United States.

(5) An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use.

(6) A description of the manner in which it is proposed that the product or class of products shall deviate from the requirements of the applicable standard.

(8) An explanation of how means of radiation protection will be provided where the product or class of products deviates from the requirements of the applicable standard.

(9) The period of time it is desired that the exemption be in effect, and, if appropriate, the number of units to be manufactured under the exemption.

(11) The name, address, and telephone number of the appropriate office of the United States department or agency purchasing the product or class of products.

(12) Such other information required by regulation or by the Director, Center for Devices and Radiological Health, to evaluate and act on the application. Where such information includes nonclinical laboratory studies, the information shall include, with respect to each nonclinical study, either a statement that each study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a statement that describes in detail all differences between the practices used in the study and those required in the regulations. When such information includes clinical investigations involving human subjects, the information shall include, with respect to each clinical investigation, either a statement that each investigation was conducted in compliance with the requirements set forth in part 56 of this chapter, or a statement that the investigation is not subject to such requirements in accordance with § 56.104 or § 56.105 and a statement that each investigation was conducted in compliance with the requirements set forth in part 50 of this chapter.

(13) With respect to each nonclinical laboratory study contained in the application, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

(c) If you are submitting an application for exemption, or for amendment or extension thereof, you must submit two copies (original and redacted version) for confidential petitions to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Otherwise, only one copy is necessary. For an exemption under the criteria prescribed in paragraph (a)(1) of this section, the application shall include the information prescribed in paragraphs (c)(1) through (13) of this section. For an exemption under the criteria prescribed in paragraph (a)(2) of this section, the application shall include the information prescribed in paragraphs (c)(3) through (13) of this section. An application for exemption, or for amendment or extension thereof, and correspondence relating to such application shall be made available for public disclosure in Dockets Management Staff, except for confidential or proprietary information submitted in accordance with part 20 of this chapter. Information classified for reasons of national security shall not be included in the application. Except as indicated in this paragraph (c), the application for exemption shall include the following:

(1) The procurement specifications for the product or class of products that govern emissions of electronic product radiation.

(2) Evidence that the product or class of products is of a type used solely or predominantly by departments or agencies of the United States.

(3) Evidence that such product or class of products is intended for use by a department or agency of the United States.

(5) An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use.

(6) A description of the manner in which it is proposed that the product or class of products shall deviate from the requirements of the applicable standard.

(8) An explanation of how means of radiation protection will be provided where the product or class of products deviates from the requirements of the applicable standard.

(9) The period of time it is desired that the exemption be in effect, and, if appropriate, the number of units to be manufactured under the exemption.

(11) The name, address, and telephone number of the appropriate office of the United States department or agency purchasing the product or class of products.

(12) Such other information required by regulation or by the Director, Center for Devices and Radiological Health, to evaluate and act on the application. Where such information includes nonclinical laboratory studies, the information shall include, with respect to each nonclinical study, either a statement that each study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a statement that describes in detail all differences between the practices used in the study and those required in the regulations. When such information includes clinical investigations involving human subjects, the information shall include, with respect to each clinical investigation, either a statement that each investigation was conducted in compliance with the requirements set forth in part 56 of this chapter, or a statement that the investigation is not subject to such requirements in accordance with § 56.104 or § 56.105 and a statement that each investigation was conducted in compliance with the requirements set forth in part 50 of this chapter.

(13) With respect to each nonclinical laboratory study contained in the application, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

(c) If you are submitting an application for exemption, or for amendment or extension thereof, you must submit two copies (original and redacted version) for confidential petitions to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Otherwise, only one copy is necessary. For an exemption under the criteria prescribed in paragraph (a)(1) of this section, the application shall include the information prescribed in paragraphs (c)(1) through (13) of this section. For an exemption under the criteria prescribed in paragraph (a)(2) of this section, the application shall include the information prescribed in paragraphs (c)(3) through (13) of this section. An application for exemption, or for amendment or extension thereof, and correspondence relating to such application shall be made available for public disclosure in Dockets Management Staff, except for confidential or proprietary information submitted in accordance with part 20 of this chapter. Information classified for reasons of national security shall not be included in the application. Except as indicated in this paragraph (c), the application for exemption shall include the following:

(1) The procurement specifications for the product or class of products that govern emissions of electronic product radiation.

(2) Evidence that the product or class of products is of a type used solely or predominantly by departments or agencies of the United States.

(3) Evidence that such product or class of products is intended for use by a department or agency of the United States.

(5) An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use.

(6) A description of the manner in which it is proposed that the product or class of products shall deviate from the requirements of the applicable standard.

(8) An explanation of how means of radiation protection will be provided where the product or class of products deviates from the requirements of the applicable standard.

(9) The period of time it is desired that the exemption be in effect, and, if appropriate, the number of units to be manufactured under the exemption.

(11) The name, address, and telephone number of the appropriate office of the United States department or agency purchasing the product or class of products.

(12) Such other information required by regulation or by the Director, Center for Devices and Radiological Health, to evaluate and act on the application. Where such information includes nonclinical laboratory studies, the information shall include, with respect to each nonclinical study, either a statement that each study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a statement that describes in detail all differences between the practices used in the study and those required in the regulations. When such information includes clinical investigations involving human subjects, the information shall include, with respect to each clinical investigation, either a statement that each investigation was conducted in compliance with the requirements set forth in part 56 of this chapter, or a statement that the investigation is not subject to such requirements in accordance with § 56.104 or § 56.105 and a statement that each investigation was conducted in compliance with the requirements set forth in part 50 of this chapter.

(13) With respect to each nonclinical laboratory study contained in the application, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

(c) If you are submitting an application for exemption, or for amendment or extension thereof, you must submit two copies (original and redacted version) for confidential petitions to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Otherwise, only one copy is necessary. For an exemption under the criteria prescribed in paragraph (a)(1) of this section, the application shall include the information prescribed in paragraphs (c)(1) through (13) of this section. For an exemption under the criteria prescribed in paragraph (a)(2) of this section, the application shall include the information prescribed in paragraphs (c)(3) through (13) of this section. An application for exemption, or for amendment or extension thereof, and correspondence relating to such application shall be made available for public disclosure in Dockets Management Staff, except for confidential or proprietary information submitted in accordance with part 20 of this chapter. Information classified for reasons of national security shall not be included in the application. Except as indicated in this paragraph (c), the application for exemption shall include the following:

(1) The procurement specifications for the product or class of products that govern emissions of electronic product radiation.

(2) Evidence that the product or class of products is of a type used solely or predominantly by departments or agencies of the United States.

(3) Evidence that such product or class of products is intended for use by a department or agency of the United States.

(5) An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use.

(6) A description of the manner in which it is proposed that the product or class of products shall deviate from the requirements of the applicable standard.

(8) An explanation of how means of radiation protection will be provided where the product or class of products deviates from the requirements of the applicable standard.

(9) The period of time it is desired that the exemption be in effect, and, if appropriate, the number of units to be manufactured under the exemption.

(11) The name, address, and telephone number of the appropriate office of the United States department or agency purchasing the product or class of products.

(12) Such other information required by regulation or by the Director, Center for Devices and Radiological Health, to evaluate and act on the application. Where such information includes nonclinical laboratory studies, the information shall include, with respect to each nonclinical study, either a statement that each study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a statement that describes in detail all differences between the practices used in the study and those required in the regulations. When such information includes clinical investigations involving human subjects, the information shall include, with respect to each clinical investigation, either a statement that each investigation was conducted in compliance with the requirements set forth in part 56 of this chapter, or a statement that the investigation is not subject to such requirements in accordance with § 56.104 or § 56.105 and a statement that each investigation was conducted in compliance with the requirements set forth in part 50 of this chapter.

(13) With respect to each nonclinical laboratory study contained in the application, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

(c) If you are submitting an application for exemption, or for amendment or extension thereof, you must submit two copies (original and redacted version) for confidential petitions to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Otherwise, only one copy is necessary. For an exemption under the criteria prescribed in paragraph (a)(1) of this section, the application shall include the information prescribed in paragraphs (c)(1) through (13) of this section. For an exemption under the criteria prescribed in paragraph (a)(2) of this section, the application shall include the information prescribed in paragraphs (c)(3) through (13) of this section. An application for exemption, or for amendment or extension thereof, and correspondence relating to such application shall be made available for public disclosure in Dockets Management Staff, except for confidential or proprietary information submitted in accordance with part 20 of this chapter. Information classified for reasons of national security shall not be included in the application. Except as indicated in this paragraph (c), the application for exemption shall include the following:

(1) The procurement specifications for the product or class of products that govern emissions of electronic product radiation.

(2) Evidence that the product or class of products is of a type used solely or predominantly by departments or agencies of the United States.

(3) Evidence that such product or class of products is intended for use by a department or agency of the United States.

(5) An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use.

(6) A description of the manner in which it is proposed that the product or class of products shall deviate from the requirements of the applicable standard.

(8) An explanation of how means of radiation protection will be provided where the product or class of products deviates from the requirements of the applicable standard.

(9) The period of time it is desired that the exemption be in effect, and, if appropriate, the number of units to be manufactured under the exemption.

(11) The name, address, and telephone number of the appropriate office of the United States department or agency purchasing the product or class of products.

(12) Such other information required by regulation or by the Director, Center for Devices and Radiological Health, to evaluate and act on the application. Where such information includes nonclinical laboratory studies, the information shall include, with respect to each nonclinical study, either a statement that each study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a statement that describes in detail all differences between the practices used in the study and those required in the regulations. When such information includes clinical investigations involving human subjects, the information shall include, with respect to each clinical investigation, either a statement that each investigation was conducted in compliance with the requirements set forth in part 56 of this chapter, or a statement that the investigation is not subject to such requirements in accordance with § 56.104 or § 56.105 and a statement that each investigation was conducted in compliance with the requirements set forth in part 50 of this chapter.

(13) With respect to each nonclinical laboratory study contained in the application, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

(c) If you are submitting an application for exemption, or for amendment or extension thereof, you must submit two copies (original and redacted version) for confidential petitions to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Otherwise, only one copy is necessary. For an exemption under the criteria prescribed in paragraph (a)(1) of this section, the application shall include the information prescribed in paragraphs (c)(1) through (13) of this section. For an exemption under the criteria prescribed in paragraph (a)(2) of this section, the application shall include the information prescribed in paragraphs (c)(3) through (13) of this section. An application for exemption, or for amendment or extension thereof, and correspondence relating to such application shall be made available for public disclosure in Dockets Management Staff, except for confidential or proprietary information submitted in accordance with part 20 of this chapter. Information classified for reasons of national security shall not be included in the application. Except as indicated in this paragraph (c), the application for exemption shall include the following:

(1) The procurement specifications for the product or class of products that govern emissions of electronic product radiation.

(2) Evidence that the product or class of products is of a type used solely or predominantly by departments or agencies of the United States.

(3) Evidence that such product or class of products is intended for use by a department or agency of the United States.

(5) An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use.

(6) A description of the manner in which it is proposed that the product or class of products shall deviate from the requirements of the applicable standard.

(8) An explanation of how means of radiation protection will be provided where the product or class of products deviates from the requirements of the applicable standard.

(9) The period of time it is desired that the exemption be in effect, and, if appropriate, the number of units to be manufactured under the exemption.

(11) The name, address, and telephone number of the appropriate office of the United States department or agency purchasing the product or class of products.

(12) Such other information required by regulation or by the Director, Center for Devices and Radiological Health, to evaluate and act on the application. Where such information includes nonclinical laboratory studies, the information shall include, with respect to each nonclinical study, either a statement that each study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a statement that describes in detail all differences between the practices used in the study and those required in the regulations. When such information includes clinical investigations involving human subjects, the information shall include, with respect to each clinical investigation, either a statement that each investigation was conducted in compliance with the requirements set forth in part 56 of this chapter, or a statement that the investigation is not subject to such requirements in accordance with § 56.104 or § 56.105 and a statement that each investigation was conducted in compliance with the requirements set forth in part 50 of this chapter.

(13) With respect to each nonclinical laboratory study contained in the application, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

(c) If you are submitting an application for exemption, or for amendment or extension thereof, you must submit two copies (original and redacted version) for confidential petitions to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Otherwise, only one copy is necessary. For an exemption under the criteria prescribed in paragraph (a)(1) of this section, the application shall include the information prescribed in paragraphs (c)(1) through (13) of this section. For an exemption under the criteria prescribed in paragraph (a)(2) of this section, the application shall include the information prescribed in paragraphs (c)(3) through (13) of this section. An application for exemption, or for amendment or extension thereof, and correspondence relating to such application shall be made available for public disclosure in Dockets Management Staff, except for confidential or proprietary information submitted in accordance with part 20 of this chapter. Information classified for reasons of national security shall not be included in the application. Except as indicated in this paragraph (c), the application for exemption shall include the following:

(1) The procurement specifications for the product or class of products that govern emissions of electronic product radiation.

(2) Evidence that the product or class of products is of a type used solely or predominantly by departments or agencies of the United States.

(3) Evidence that such product or class of products is intended for use by a department or agency of the United States.

(5) An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use.

(6) A description of the manner in which it is proposed that the product or class of products shall deviate from the requirements of the applicable standard.

(8) An explanation of how means of radiation protection will be provided where the product or class of products deviates from the requirements of the applicable standard.

(9) The period of time it is desired that the exemption be in effect, and, if appropriate, the number of units to be manufactured under the exemption.

(11) The name, address, and telephone number of the appropriate office of the United States department or agency purchasing the product or class of products.

(12) Such other information required by regulation or by the Director, Center for Devices and Radiological Health, to evaluate and act on the application. Where such information includes nonclinical laboratory studies, the information shall include, with respect to each nonclinical study, either a statement that each study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a statement that describes in detail all differences between the practices used in the study and those required in the regulations. When such information includes clinical investigations involving human subjects, the information shall include, with respect to each clinical investigation, either a statement that each investigation was conducted in compliance with the requirements set forth in part 56 of this chapter, or a statement that the investigation is not subject to such requirements in accordance with § 56.104 or § 56.105 and a statement that each investigation was conducted in compliance with the requirements set forth in part 50 of this chapter.

(13) With respect to each nonclinical laboratory study contained in the application, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.