[Federal Register Volume 89, Number 182 (Thursday, September 19, 2024)]
[Notices]
[Pages 76853-76855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21436]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-4167]


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 or Agency) 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 revision 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: Either electronic or written comments on the collection of 
information must be submitted by November 18, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 18, 2024. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-
2024-N-4167 for ``Agency Information Collection Activities; Proposed 
Collection; Comment Request; Labeling Requirements for Prescription 
Drugs.'' 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.
    <bullet> 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

[[Page 76854]]

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, 
<a href="/cdn-cgi/l/email-protection#114143504265707777517775703f7979623f767e67"><span class="__cf_email__" data-cfemail="a3f3f1e2f0d7c2c5c5e3c5c7c28dcbcbd08dc4ccd5">[email protected]</span></a>.

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 revision 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 helps implement statutory and 
regulatory requirements that govern the labeling of prescription drugs. 
FDA regulations codified in part 201 (21 CFR part 201), subpart B 
(Sec.  201.50 to Sec.  201.58) apply to requisite labeling elements 
that include a statement of identity; a declaration of net quantity of 
contents; a statement of dosage; and specific content and formatting of 
information. The regulations also provide for requesting that FDA waive 
any requirement under Sec. Sec.  201.56, 201.57, and 201.80. Since last 
approval of the information collection, FDA requested, and OMB 
approved, adding tasks provided for under Sec.  201.25(d), requiring 
that manufacturers submit a written request for exemption from 
applicable bar code requirements, and tasks relating to exceptions or 
alternatives to the labeling requirements of products in the Strategic 
National Stockpile (SNS) as provided for in Sec.  201.26, to the scope 
of the activity. Under the Public Health Service Act (PHS Act), the 
Department of Health and Human Services stockpiles medical products 
that are essential to the security of the Nation (section 319F-2 of the 
PHS Act (42 U.S.C. 247d-6b). Information regarding the SNS is available 
at the following website: www.phe.gov/about/sns/Pages/default.aspx.
    Relevant information regarding applicable statutory and regulatory 
requirements are also discussed in topic-specific guidance documents 
issued consistent with 21 CFR 314.445, 21 CFR 601.29 (guidance 
documents), and Agency Good Guidance Practice regulations in 21 CFR 
10.115, which provide for public comment at any time. The following 
guidance documents discuss activities included in the information 
collection:
    ``Safety Labeling Changes--Implementation of Section 505(o)(4) of 
the Federal Food, Drug, and Cosmetic Act,'' (July 2013). The guidance 
document includes instruction on communicating with FDA regarding 
labeling changes required under section 505(o)(4) (Section IV--
Procedures) and is available for download from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-labeling-changes-implementation-section-505o4-federal-food-drug-and-cosmetic-act.
    ``Guidance for Industry on Hypertension Indication: Drug Labeling 
for Cardiovascular Outcome Claims,'' (March 2011). The guidance 
document is intended to help respondents with developing labeling for 
cardiovascular outcome claims for drugs that are indicated to treat 
hypertension. The guidance document is available for download from our 
website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/hypertension-indication-drug-labeling-cardiovascular-outcome-claims.
    Respondents to the information collection are sponsors of product 
labeling subject to the applicable labeling requirements. We 
characterize the information collection activities as recordkeeping, 
consistent with 5 CFR 1320.3(m), noting that a recordkeeping 
requirement means a requirement to maintain specified records, 
including the requirement to retain, notify third parties, the Federal 
government, or the public regarding such records. Regulations in part 
201 govern the statement of ingredients and declaration of net quantity 
of contents with regard to prescription drug product labeling. The 
regulations require that firms identify bulk or transport containers 
with the name of the product contained therein and that containers be 
accompanied by documentation that identifies the product as meeting 
applicable compendial standards. 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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 76855]]



                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
            Activity/21 CFR section                Number of     responses per   Total annual          Average burden per response          Total hours
                                                  respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling requirements for prescription drugs;              414           1.326             549  3,349...................................       1,838,601
 Sec.  Sec.   201.56 and 201.57.
Labeling applicable to medical gas containers;             260           1,663         432,380  0.17 (10 minutes).......................          73,505
 Sec.  Sec.   201.161(b) and 201.328.
Exemption from barcode requirements Sec.                     2               1               2  24......................................              48
 201.25(d).
Safety labeling required under section                      36               1              36  6.......................................             216
 505(o)(4) of the Federal Food, Drug, and
 Cosmetic Act (FD&C Act), and rebuttal
 statement.
Safety labeling changes; posting approved                  351               1             351  4.......................................           1,404
 letter on application holder's website.
Exceptions or alternatives to labeling                       1               1               1  32......................................              32
 requirements for human drug product held by
 SNS; Sec.   201.26.
Hypertension claims; recommended labeling                    5               1               5  18......................................              90
 considerations.
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............         433,324  ........................................       1,913,896
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on our evaluation, we have retained the currently approved 
estimate that 414 applicants will prepare an average of 549 
prescription drug labels annually, 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.
    New medical gas containers must meet applicable requirements found 
in 21 CFR part 211, as well as specific labeling requirements in Sec.  
201.328. Consistent with statutory authority under the Consolidated 
Appropriations Act, 2017 (Pub. L. 115-31), we have revised the 
information collection to include burden associated new medical gas 
labeling requirements under Sec.  201.161(b), established by a final 
rule published in the Federal Register of June 18, 2024 (89 FR 51738). 
We estimate 260 respondents will incur burden for the design, testing, 
production, and submission of labeling for new medical gas containers 
as established in Sec.  201.328 and assume an average of 10 minutes 
(0.17) is required for these activities.
    Based on our evaluation, few requests for exemption from barcode 
requirements are received and we have therefore made no changes to the 
currently approved estimate for this activity. Likewise, we have also 
retained the currently approved estimate for information collection 
activities associated with safety labeling requirements established in 
section505(o)(4) of the FD&C Act. Similarly, we retain the currently 
approved estimate for exceptions to labeling under Sec.  201.26, 
however this activity was previously approved in OMB control number 
0910-0614 and is a new element to the collection, adding 1 response and 
32 hours annually.
    Finally, we have combined activity elements associated with 
labeling recommendations regarding drug products that include a 
hypertension indication as discussed in the applicable guidance, 
reducing the overall estimate for this element by 4 hours annually.

    Dated: September 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21436 Filed 9-18-24; 8:45 am]
BILLING CODE 4164-01-P


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