Source: https://www.federalregister.gov/documents/2010/01/05/E9-31199/agency-information-collection-activities-submission-for-office-of-management-and-budget-review
Timestamp: 2017-08-18 13:53:38
Document Index: 751432478

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379-382 (4 pages)
Environmental Impact Considerations—21 CFR Part 25—OMB Control Number 0910-0322)—Extension
Estimated Annual Reporting Burden for Human Drugs (Including Biologics in the Center for Devices and Radiological Health)
https://www.federalregister.gov/d/E9-31199 https://www.federalregister.gov/d/E9-31199
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0322. Also include the FDA docket number found in brackets in the heading of this document.
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 a 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. Section 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. Section 25.40(a) and (c) specifies the content requirements for EAs for nonexcluded actions.
This collection of information is used by FDA to assess the environmental impact of agency actions and to ensure that the public is informed of environmental analyses. Firms wishing to manufacture and market substances regulated under statutes for which FDA is responsible must, in most instances, submit applications requesting approval. Environmental information must be included in such applications for the purpose of determining whether the proposed action may have a significant impact on the environment. Where significant adverse effects cannot be avoided, the agency uses the submitted information as the basis for Start Printed Page 380preparing and circulating to the public an EIS, made available through a Federal Register document also filed for comment at the Environmental Protection Agency. The final EIS, including the comments received, is reviewed by the agency to weigh environmental costs and benefits in determining whether to pursue the proposed action or some alternative that would reduce expected environmental impact.
Under 21 CFR 71.1, 171.1, 170.39, and 170.100, food additive petitions, color additive petitions, requests for 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. In 2008, FDA received 112 industry submissions. FDA received an annual average of 67 claims of categorical exclusions as required under § 25.15(a) and (d), and 45 EAs as required under § 25.40(a) and (c). FDA estimates that, on average, it takes petitioners, notifiers, or requestors approximately 3 hours to prepare a claim of categorical exclusion and approximately 210 hours to prepare an EA.
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 environmental assessment under § 25.40. In 2008, FDA received approximately 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). Based on information provided by less than 10 sponsors, FDA estimates that it takes approximately 6 hours to prepare a claim for a categorical exclusion and an unknown number of hours to prepare an EA.Start Printed Page 381
Under § 312.23(a)(7)(iv)(e) and 21 CFR 601.2(a), IND and BLAs must contain a claim for categorical exclusion under § 25.30 or § 25.31 or an EA under § 25.40. In 2008, FDA received 245 INDs from 180 sponsors; 28 BLAs from 13 applicants; and 972 BLA supplements to license applications from 173 applicants. FDA estimates that approximately 10 percent of these supplements would be submitted with a claim for categorical exclusion or an EA.
Under 21 CFR 514.1(b)(14), new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs); § 514.8(a)(1) supplemental NADAs and ANADAs; § 511.1(b)(10) investigational new animal drug applications (INADs); and § 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. In 2008, FDA's Center for Veterinary Medicine has received approximately 676 claims for categorical exclusion as required under § 25.15(a) and (d), and 8 EAs as required under § 25.40(a) and (c). FDA estimates that it takes sponsors/applicants approximately 5 hours to prepare a claim for a categorical exclusion and an average of 2,160 hours to prepare an EA.
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In the Federal Register of September 9, 2009 (74 FR 46430), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
[FR Doc. E9-31199 Filed 1-4-10; 8:45 am]