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Federal Register / Vol. 86, No. 170 / Tuesday, September 7, 2021 / Notices For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in Instructions.
Instructions: All submissions received must include Docket No. FDA2021N
0918 for Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling Requirements for Prescription Drugs and Biological Products. Received comments, those filed in a timely manner see ADDRESSES, will be placed in the docket and, except for those submitted as Confidential Submissions, publicly viewable at https www.regulations.gov or at the Dockets Management Staff between 9
a.m. and 4 p.m., Monday through Friday, 2404027500.
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.

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respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

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:
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601
Landsdown St., North Bethesda, MD
20852, 3017965733, 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 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
Labeling Requirements for Prescription Drugs OMB Control Number 09100572
Revision This information collection supports FDA regulations governing the labeling of prescription drugs. The regulations are codified in 21 CFR part 201, subpart B 21 CFR 201.50 through 201.58 and set forth both general requirements, as well as specific content and format requirements. The regulations also provide for requesting a waiver from any labeling requirement and do not apply to biological products that are subject to the requirements of section 351 of the Public Health Service Act.
We are revising the information collection to include burden associated with regulations applicable to medical gas labeling found in 201.328 21 CFR
201.328 and established by a final rule in the Federal Register of November 18, 2016 81 FR 81685 at 81694. While we included corresponding changes and adjustments resulting from the final rule to the information collection approved under OMB control number 09100139
as it pertains to good manufacturing practice requirements and regulations in part 211 21 CFR part 211, we did not make corresponding changes and adjustments to this information collection with regard to burden that may be associated with labeling requirements found in 201.328 81 FR
81685 at 81694.
To assist respondents with the information collection we continue to develop and issue guidance documents, available from our searchable guidance database at https www.fda.gov/
regulatory-information/search-fdaguidance-documents. All Agency guidance documents are issued consistent with our good guidance practice regulations found in 21 CFR
10.115, which provide for public comment at any time.
We estimate the burden of the information collection as follows:

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TABLE 1ESTIMATED ANNUAL REPORTING BURDEN 1
Number of respondents
Activity/21 CFR Section Labeling requirements for prescription drugs;
201.56 and 201.57.
Labeling of medical gas containers; 201.328

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Number of responses per respondent
Total annual responses
Average burden per response
Total hours
414

1.326

549

3,349

1,838,601

260

1,663

432,380

0.17 10 minutes ..

43,238

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