Notice2024-21436
Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling Requirements for Prescription Drugs
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 19, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 182 (Thursday, September 19, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 182 (Thursday, September 19, 2024)]
[Notices]
[Pages 76853-76855]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21436]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: <a href="http://www.phe.gov/about/sns/Pages/default.aspx">www.phe.gov/about/sns/Pages/default.aspx</a>.
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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-labeling-changes-implementation-section-505o4-federal-food-drug-and-cosmetic-act">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-labeling-changes-implementation-section-505o4-federal-food-drug-and-cosmetic-act</a>.
``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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/hypertension-indication-drug-labeling-cardiovascular-outcome-claims">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/hypertension-indication-drug-labeling-cardiovascular-outcome-claims</a>.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on September 19, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.