Source: https://www.federalregister.gov/documents/2015/09/08/2015-22507/agency-information-collection-activities-proposed-collection-comment-request-environmental-impact
Timestamp: 2017-11-18 12:42:03
Document Index: 99905986

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A Notice by the Food and Drug Administration on 09/08/2015
Submit either electronic or written comments on the collection of information by November 9, 2015.
80 FR 53807
53807-53810 (4 pages)
Environmental Impact Considerations—21 CFR Part 25
OMB Control Number 0910-0322
https://www.federalregister.gov/d/2015-22507 https://www.federalregister.gov/d/2015-22507
FDA is requesting OMB approval for the reporting requirements contained in the FDA collection of information “Environmental Impact Considerations.” The National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4347) states national environmental objectives and imposes upon each Federal Agency the duty to consider the environmental effects of its actions. Section 102(2)(C) of NEPA requires the preparation of an Start Printed Page 53808environmental impact statement (EIS) for every major Federal action that will significantly affect the quality of the human environment.
FDA's NEPA regulations are in part 25 (21 CFR part 25). All applications or petitions requesting Agency action require the submission of a claim for categorical exclusion or an environmental assessment (EA). A categorical exclusion applies to certain classes of FDA-regulated actions that usually have little or no potential to cause significant environmental effects and are excluded from the requirements to prepare an EA or EIS. Sections 25.15(a) and (d) specifies the procedures for submitting to FDA a claim for a categorical exclusion. Extraordinary circumstances (§ 25.21), which may result in significant environmental impacts, may exist for some actions that are usually categorically excluded. An EA provides information that is used to determine whether an FDA action could result in a significant environmental impact. Sections 25.40(a) and (c) specifies the content requirements for EAs for non-excluded actions.
Under 21 CFR 312.23(a)(7)(iv)(c), 314.50(d)(1)(iii), and 314.94(a)(9)(i), each investigational new drug application (IND), new drug application (NDA), and abbreviated new drug application (ANDA) must contain a claim for categorical exclusion under § 25.30 or § 25.31, or an EA under § 25.40. Annually, FDA receives approximately 3,677 INDs from 2501 sponsors; 120 NDAs from 87 applicants; 2,718 supplements to NDAs from 399 applicants; 9 biologic license applications (BLAs) from 8 applicants; 317 supplements to BLAs from 43 applicants; 1475 ANDAs from 300 applicants; and 5448 supplements to ANDAs from 318 applicants. FDA estimates that it receives approximately 13,663 claims for categorical exclusions as required under §§ 25.15(a) and (d), and 11 EAs as required under §§ 25.40(a) and (c). Based on information provided by the pharmaceutical industry, FDA estimates that it takes sponsors or applicants approximately 8 hours to prepare a claim for a categorical exclusion and approximately 3,400 hours to prepare an EA.
25.15(a) and (d) 3,416 4 13,664 8 109,312
Total 146,712
Under 21 CFR 71.1, 171.1, 170.39, and 170.100, food additive petitions, color additive petitions, requests from exemption from regulation as a food additive, and submission of a food contact notification for a food contact substance must contain either a claim of categorical exclusion under § 25.30 or § 25.32 or an EA under § 25.40. Annually, FDA receives approximately 97 industry submissions. FDA received an annual average of 42 claims of categorical exclusions as required under § 25.15(a) and (d) and 33 EAs as required under §§ 25.40(a) and (c). FDA estimates that approximately 42 respondents will submit an average of 1 application for categorical exclusion and 33 respondents will submit an average of 1 EA. FDA estimates that, on average, it takes petitioners, notifiers, or requestors approximately 8 hours to prepare a claim of categorical exclusion and approximately 210 hours to prepare an EA.
Start Printed Page 53809
Under 21 CFR 814.20(b)(11), premarket approvals (PMAs) (original PMAs and supplements) must contain a claim for categorical exclusion under § 25.30 or § 25.34 or an EA under § 25.40. In 2012 to 2014, FDA received an average of 39 claims (original PMAs and supplements) for categorical exclusions as required under §§ 25.15(a) and (d), and 0 EAs as required under §§ 25.40(a) and (c). FDA estimates that approximately 39 respondents will submit an average of 1 application for categorical exclusion annually. Based on information provided by sponsors, FDA estimates that it takes approximately 6 hours to prepare a claim for a categorical exclusion.
Under 21 CFR 601.2(a), BLAs as well as INDs (§ 312.23), NDAs (§ 314.50), ANDAs (§ 314.94), and PMAs (§ 814.20) must contain either a claim of categorical exclusion under § 25.30 or 25.32 or an EA under § 25.40. Annually, FDA receives approximately 34 BLAs from 18 applicants, 801 BLA supplements to license applications from 156 applicants, 345 INDs from 256 sponsors, 1 NDA from 1 applicant, 26 supplements to NDAs from 8 applicants, 1 ANDA from 1 applicant, 1 supplement to ANDAs from 1 applicant, 8 PMAs from 3 applicants, and 33 PMA supplements from 16 applicants. FDA estimates that approximately 10 percent of these supplements would be submitted with a claim for categorical exclusion or an EA.
FDA has received approximately 481 claims for categorical exclusion as required under §§ 25.15(a) and (d) annually and 2 EAs as required under §§ 25.40(a) and (c) annually. Therefore, FDA estimates that approximately 247 respondents will submit an average of 2 applications for categorical exclusion and 2 respondents will submit an average of 1 EA. Based on information provided by industry, FDA estimates that it takes sponsors and applicants approximately 8 hours to prepare a claim of categorical exclusion and approximately 3,400 hours to prepare an EA for a biological product.
Table 4—Estimated Annual Reporting Burden for Biological Products1
25.15(a) and (d) 247 2 494 8 3,952
Under 21 CFR 514.1(b)(14), new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs); 21 CFR 514.8(a)(1) supplemental NADAs and ANADAs; 21 CFR 511.1(b)(10) investigational new animal drug applications (INADs), and 21 CFR 571.1(c) food additive petitions must contain a claim for categorical exclusion under § 25.30 or 25.33 or an EA under § 25.40. Annually, FDA's Center for Veterinary Medicine has received approximately 698 claims for categorical exclusion as required under §§ 25.15(a) and (d), and 10 EAs as required under §§ 25.40(a) and (c). FDA estimates that approximately 70 respondents will submit an average of 10 applications for categorical exclusion and 10 respondents will submit an average of 1 EA. FDA estimates that it takes sponsors/applicants approximately 3 hours to prepare a claim of categorical exclusion and an average of 2,160 hours to prepare an EA.Start Printed Page 53810
25.15(a) and (d) 70 10 700 3 2,100
25.40(a) and (c) 10 1 10 2,160 21,600
Under sections 905, 910, and 911 of the Federal Food, Drugs, and Cosmetic Act (21 U.S.C. 387, 387j, and 387k), product applications and supplements (PMTAs), SEs, Exemption from SEs, and modified risk tobacco products must contain a claim for categorical exclusion or an EA. In 2015, FDA estimated it will receive approximately 5 premarket review of new tobacco PMTAs from 5 respondents, 509 reports intended to demonstrate the substantial equivalence of a new tobacco product (SEs) from 509 respondents, 15 exemption from substantial equivalence requirements applications (SE Exemptions) from 15 respondents, and 3 modified risk tobacco product applications (MRTPAs) from 3 respondents. FDA is not accepting claims for categorical exclusions at this time, and estimates that there will be 532 EAs from 532 respondents as required under §§ 25.40(a) and (c). Therefore, over the next 3 years, FDA estimates that approximately 532 respondents will submit an average of 1 application for environmental assessment. Part of the information in the EA will be developed while writing other parts of a PMTA, SE, Exemption from SE, or MRTPA. Based on FDA's experience, previous information provided by potential sponsors and knowledge that part of the EA information has already been produced in one of the tobacco product applications, FDA estimates that it takes approximately 80 hours to prepare an EA.
25.40(a) and (c) 532 1 532 80 42,560
[FR Doc. 2015-22507 Filed 9-4-15; 8:45 am]