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Federal Register / Vol. 86, No. 162 / Wednesday, August 25, 2021 / Notices
Confidential SubmissionsTo submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as confidential. Any information marked as confidential will not be disclosed except in accordance with 21 CFR 10.20
and other applicable disclosure law. For more information about FDAs posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https
www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the Search box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 2404027500.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601
Landsdown St., North Bethesda, MD
20852, 3017968867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA 44 U.S.C. 35013521, Federal Agencies must obtain approval from the Office of Management and Budget OMB for each collection of information they conduct or sponsor.
Collection of information is defined in 44 U.S.C. 35023 and 5 CFR
1320.3c and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party.
Section 3506c2A of the PRA 44
U.S.C. 3506c2A requires Federal
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Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB
for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA invites comments on these topics: 1 Whether the proposed collection of information is necessary for the proper performance of FDAs functions, including whether the information will have practical utility; 2 the accuracy of FDAs estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3 ways to enhance the quality, utility, and clarity of the information to be collected; and 4
ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Environmental Impact Considerations OMB Control Number 09100322
Extension I. Background 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. 43214347 states national environmental objectives and imposes upon each Federal Agency the duty to consider the environmental effects of its actions. Section 1022C of NEPA
requires the preparation of an environmental impact statement EIS
for every major Federal action that will significantly affect the quality of the human environment.
FDAs 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. In 25.15a and d 21 CFR 25.15a and d the procedures for submitting to FDA a claim for a categorical exclusion are specified. Extraordinary circumstances under 21 CFR 25.21, which may result
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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 25.40a and c 21 CFR
25.40a and c specifies the content requirements for EAs for non-excluded 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 events cannot be avoided, the Agency uses the submitted information as the basis for preparing 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.
Any final EIS would contain additional information gathered by the Agency after the publication of the draft EIS, a copy or a summary of the comments received on the draft EIS, and the Agencys responses to the comments, including any revisions resulting from the comments or other information. When the Agency finds that no significant environmental effects are expected, the Agency prepares a finding of no significant impact.
FDA estimates the burden of this collection of information as follows:
II. Estimated Annual Reporting Burden for Human Drugs Including Biologics in the Center for Drug Evaluation and Research Under 312.23a7ive, 314.50d1iii, and 314.94a9i 21
CFR 312.23a7ive, 314.50d1iii, and 314.94a9i, 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 21 CFR 25.30 or 25.31 21
CFR 25.31, or an EA under 25.40.
Annually, FDA receives approximately
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