[Federal Register Volume 86, Number 170 (Tuesday, September 7, 2021)]
[Notices]
[Pages 50134-50136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19218]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0918]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Labeling Requirements for Prescription Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
associated with labeling requirements for prescription drugs.

DATES: Submit either electronic or written comments on the collection 
of information by November 8, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 8, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 8, 2021. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

[[Page 50135]]

     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. FDA-
2021-N-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, 240-402-7500.
     Confidential Submissions--To 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 FDA's 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-2015-09-18/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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
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 FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's 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.

Labeling Requirements for Prescription Drugs

OMB Control Number 0910-0572--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 
Sec.  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 
0910-0139 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 Sec.  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-fda-guidance-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:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                   Number of
            Activity/21 CFR Section                Number of     responses per   Total annual          Average burden per response          Total hours
                                                  respondents     respondent       responses
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Labeling requirements for prescription drugs;              414           1.326             549  3,349...................................       1,838,601
 Sec.  Sec.   201.56 and 201.57.
Labeling of medical gas containers; Sec.                   260           1,663         432,380  0.17 (10 minutes).......................          43,238
 201.328.
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[[Page 50136]]

 
    Total.....................................  ..............  ..............         432,929  ........................................       1,881,839
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    New drug product and biological product applicants must: (1) Design 
and create prescription drug labeling containing ``Highlights,'' 
``Contents,'' and ``Full Prescribing Information''; (2) test the 
designed labeling (for example, to ensure that the designed labeling 
fits into carton-enclosed products); and (3) submit it to FDA for 
approval. Based on our experience with the information collection, we 
estimate 414 applicants will prepare an average of 549 prescription 
drug labels and assume it will require 3,349 hours to design, test, and 
submit to FDA as part of a new drug application or a biologics license 
application. Similarly, new medical gas containers must meet applicable 
requirements found in part 211, as well as specific labeling 
requirements in Sec.  201.328. We estimate that 260 respondents will 
incur burden for the design, testing, production, and submission of 
labeling for new medical gas containers as required under Sec.  201.328 
and assume an average of 10 minutes (0.17) is required for these 
activities.
    Our estimated burden for the information collection reflects an 
overall increase resulting from an increase in submissions for new 
product labeling as well as from the revision to include burden 
associated with requirements in Sec.  201.328.

    Dated: August 31, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19218 Filed 9-3-21; 8:45 am]
BILLING CODE 4164-01-P


