Notice2022-27016
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Drug Labeling Provisions and Over-the-Counter Monograph Drug User Fee Submissions
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Published
December 13, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 87 Issue 238 (Tuesday, December 13, 2022)</title>
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[Federal Register Volume 87, Number 238 (Tuesday, December 13, 2022)]
[Notices]
[Pages 76200-76203]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-27016]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1794]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; General Drug Labeling
Provisions and Over-the-Counter Monograph Drug User Fee Submissions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by January 12, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0340. Also include the FDA docket
number found in brackets in the heading of this document.
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#510103100225303737113735307f3939227f363e27"><span class="__cf_email__" data-cfemail="6a3a382b391e0b0c0c2a0c0e0b44020219440d051c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
General Drug Labeling Provisions and OTC Monograph Drug User Fee
Submissions--21 CFR Part 201
OMB Control Number 0910-0340--Revision
I. Over-the-Counter (OTC) Drug Product Labeling
This information collection supports implementation of general drug
labeling provisions, including certain OTC drug product labeling
requirements found in FDA regulations in 21 CFR part 201 and in section
502(x) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 352(x)), as well as OTC drug product labeling recommendations
discussed in FDA guidance documents enumerated below. The requirements
and recommendations contained in this authority help ensure that OTC
drug product labeling includes information to assist consumers with
product selection and with the safe and effective use of products that
protect the public health from potential harm that could result from
the dissemination of false and misleading statements regarding FDA-
regulated products. As described further below, the information
collection provisions of one guidance also apply to prescription drug
labeling.
A. Principal Display Panel Labeling
Certain information collection provisions address the labeling
(third-party disclosures) that drug companies provide on the principal
display panel of every OTC drug product in package form--the part of
that drug product's label that is most likely to be displayed or
examined in a retail sale setting (see 21 CFR 201.60). Information on
this panel supports consumers' product selection, as well as
identification after purchase. OTC drug product companies must include
a declaration of the net quantity of the OTC product contents on the
principal display panel (see Sec. 201.62 (21 CFR 201.62)). They also
must include a statement of identity (see Sec. 201.61 (21 CFR
201.61)).
FDA has made available a draft guidance for industry entitled
``Statement of Identity and Strength--Content and Format of Labeling
for Human Nonprescription Drug Products'' \1\ (available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quantitative-labeling-sodium-potassium-and-phosphorus-human-over-counter-and-prescription-drug">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quantitative-labeling-sodium-potassium-and-phosphorus-human-over-counter-and-prescription-drug</a>) that further addresses content and
format of statement of identity information and drug product strength
information to be included in the principal display panel labeling of
human nonprescription drug products. The guidance provides
recommendations to help manufacturers comply with statement of identity
labeling requirements under Sec. 201.61 and also provides a
recommended alternative to the statement required by that regulation to
provide consumers with consistent information about the active
ingredients, strength, and dosage form of the product. Consistent
information about the active ingredients, strength, and dosage form of
the product on the principal display panel may aid consumers in
comparing nonprescription drug products and assist consumers in
appropriate self-selection of these products and in subsequent
identification of the products after purchase.
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\1\ When final, this guidance will represent FDA's current
thinking on this topic.
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In estimating burden for statement of identity labeling, we have
excluded the burden for disclosing any statement of identity specified
in a final OTC monograph order under section 505G of the FD&C Act (21
U.S.C. 355h), because FDA regulations state that for purposes of Sec.
201.61, the statement of identity shall be the term or phrase used in
an applicable OTC monograph (see 21 CFR 330.1(c)(1)). By operation of
law, OTC monographs are now established by order under section 505G of
the FD&C Act, and information collections made under section 505G are
exempt from the PRA under section 505G(o) of the FD&C Act.
B. OTC Drug and Prescription Drug Facts Labeling
In addition to labeling that drug companies provide on the
principal display panel, companies must also comply with Agency
regulations in Sec. 201.66 (21 CFR 201.66), which requires standard
content elements and formatting for the ``Drug Facts'' labeling (DFL)
of all OTC drug products. This standardized labeling helps consumers
understand the information that appears on OTC drug products to help
ensure that consumers can use those products safely and effectively.
The use of consistent language in labeling headings and subheadings
helps consumers comprehend information, and consistent formatting helps
consumers more efficiently locate information.
The DFL is where OTC drug product labeling presents certain
specific, standardized content required or recommended under other
regulations
[[Page 76201]]
or guidance documents. For this reason, our burden estimates address
these information collections together. One such provision authorizes
the optional use of a symbol to convey warnings regarding use of an OTC
drug product while pregnant or breast-feeding (see Sec. 201.63(a) (21
CFR 201.63(a)). In addition, the DFL is where OTC drug product labeling
presents information (if applicable) on the quantity per dosage unit of
certain specific substances. Some consumers need to restrict their
total daily intake of these substances because of their impact on the
consumers' underlying health conditions. Specific quantitative
information must be presented in OTC drug product labeling for
phenylalanine/aspartame (Sec. 201.21(b) (21 CFR 201.21(b))), sodium
(Sec. 201.64(b) (21 CFR 201.64(b))), calcium (Sec. 201.70(b) (21 CFR
201.70(b))), magnesium (Sec. 201.71(b) (21 CFR 201.71(b))), and
potassium (Sec. 201.72(b) (21 CFR 201.72(b))).
The quantitative labeling requirements in those regulations cited
above are complemented by the draft guidance for industry entitled
``Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human
Over-the-Counter and Prescription Drug Products'' \2\ (available at
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quantitative-labeling-sodium-potassium-and-phosphorus-human-over-counter-and-prescription-drug">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quantitative-labeling-sodium-potassium-and-phosphorus-human-over-counter-and-prescription-drug</a>) (Quantitative Sodium, Potassium,
and Phosphorus Labeling Guidance). This draft guidance document
provides content and formatting recommendations for presenting
quantitative information about sodium, potassium, and phosphorus that
can help firms comply with the requirements under Sec. Sec. 201.64 and
201.72 for conveying information about these substances in OTC drug
product labeling. The draft guidance also provides parallel
recommendations for drug companies to provide quantitative information
about phosphorus in OTC drug product labeling. This quantitative
information about sodium, potassium, and phosphorus helps patients who
need to limit their overall consumption of any of these substances
because of its impact on underlying health conditions, such as heart
failure, hypertension, or chronic kidney disease. Quantifying these
substances in drug labeling can also help healthcare providers and
patients select drug products with lower amounts of these substances
when such alternatives are available. The draft guidance recommends
approaches to improve consistency in the presentation of this
information, including clarifying quantities per dosage unit and
rounding consistency. The information collections addressed in the
draft guidance with regard to OTC drug products are included with our
estimates for preparing the DFL panel of labeling, where this
information appears.
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\2\ When final, this guidance will represent FDA's current
thinking on this topic.
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The Quantitative Sodium, Potassium, and Phosphorus Labeling
Guidance also recommends how drug firms can provide quantitative
information on sodium, potassium, and phosphorus in prescription drug
labeling to help patients who need to limit their overall consumption
of these substances. Prescription drugs are not subject to the OTC
labeling regulations, but the content and format of prescription drug
labeling is set forth in 21 CFR 201.56 and 201.57 and approved under
OMB control number 0910-0572. In the guidance, FDA recommends that when
the recommended quantitative information about sodium, potassium, and
phosphorus is included in prescription drug labeling, it should be
presented within the DESCRIPTION section of that labeling, following
the list of inactive ingredients. We estimate that the recommendations
of the guidance regarding disclosing quantitative information about
sodium, potassium, and phosphorus in prescription drug labeling will
have no effect on the overall burden estimate for prescription drug
labeling as a whole, which is addressed under OMB control number 0910-
0572.
Our estimate of burden for OTC drug labeling that appears within
the DFL reflects several considerations. For those OTC drug products
that are marketed pursuant to an application approved under section 505
of the FD&C Act (21 U.S.C. 355), we assume a substantial part of the
burden of developing labeling is addressed in the submission of the new
drug application, which includes submission of the proposed labeling.
The information collections associated with new drug applications are
approved under OMB control number 0910-0001. For OTC drugs that are
legally marketed under section 505G of the FD&C Act that do not have an
approved application under section 505 of the FD&C Act, a substantial
part of the DFL's content, including applicable Uses (Indications),
Warnings, and Directions, is established under section 505G, either by
final administrative orders or by section 505G(a)(3) of the FD&C Act.
Collections of information made under section 505G of the FD&C Act are
exempt from the PRA. Therefore, labeling required by administrative
orders under section 505G of the FD&C Act or required by section
505G(a)(3) of the FD&C Act, even if it would ordinarily be a collection
of information,\3\ is exempt from the PRA and is not considered in our
burden estimate for the DFL (see section 505G(o) of the FD&C Act).
Finally, we note that the DFL of many individual products already being
marketed will remain unchanged within a given year. Thus, our
annualized burden estimate encompasses only new products or those
otherwise undergoing changes, such as reformulation, or changes in
package quantity that necessitate revisions to the DFL, whether those
products are marketed under approved applications (e.g., new drug
application/abbreviated new drug application) or pursuant to section
505G of the FD&C Act.
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\3\ Some labeling required by these administrative orders or
section 505G(a)(3) of the FD&C Act is not a collection of
information at all, but rather, is the public disclosure of
information originally supplied by the Federal government to the
recipient for the purpose of disclosure to the public (see 5 CFR
1320.3(c)(2))).
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Our annualized estimate of burden addresses new products and
products for which the DFL and/or net quantity of contents otherwise
change in a 12-month period.
C. Labeling Related to Adverse Event Reporting
Section 502(x) of the FD&C Act requires the label of a
nonprescription drug product marketed in the United States without an
application approved under section 505 of the FD&C Act to include a
domestic address or domestic telephone number through which a
manufacturer, packer, and distributor may receive a report of a serious
adverse event associated with its product(s). To help implement this
provision, we developed the guidance for industry entitled ``Labeling
of Nonprescription Human Drug Products Marketed Without an Approved
Application as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act: Questions and Answers'' (September 2009)
(available at <a href="https://www.fda.gov/media/77411/download">https://www.fda.gov/media/77411/download</a>). This guidance
document is intended to assist respondents in complying with this
statutory labeling requirement and provides recommendations for
manufacturers to include an additional labeling statement identifying
the purpose of the domestic address or telephone number to improve the
usefulness of the labeling for consumers.
[[Page 76202]]
D. Submissions To Request Exemptions or Deferrals From OTC Drug
Labeling Requirements
FDA regulations in Sec. 201.66(e) authorize FDA to exempt or defer
specific requirements in Sec. 201.66 if FDA finds that the requirement
is inapplicable, impracticable, or contrary to public health or safety.
A manufacturer, packer, or distributor can seek such an exemption or
deferral by submitting a written request in accordance with the
requirements of Sec. 201.66(e), which address the content of such a
written request submission and how and where to submit it. A request
for an exemption or deferral must be submitted in triplicate for each
OTC drug product and contain certain information allowing the Agency to
make an informed decision on the request. FDA uses the submitted
information to assess whether the grounds for an exemption or deferral
are met. Based on historical experience and from feedback received from
respondents who have submitted similar requests, FDA estimates that it
will take 24 hours to prepare and submit each submission and that on
average annually, the Agency will receive one request for a waiver or
exemption from the drug labeling requirement.
In addition, Sec. 201.63(d) states that FDA may grant exemptions
from the specific OTC drug product warning for patients who are
pregnant or breast feeding that is ordinarily required to appear in
labeling by Sec. 201.63(a). To request such an exemption, the
regulations call for submission of a citizen petition in accordance
with Sec. 10.30 (21 CFR 10.30). The submission of citizen petitions
under Sec. 10.30, including those petitions that request this labeling
exemption, is approved under OMB control number 0910-0191, and we do
not address its burden further in this document.
In the Federal Register of September 9, 2022 (87 FR 55440) we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden for New OTC Drug Products 1
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Number of
Information collection activity--labeling Number of disclosures per Total annual Average burden per disclosure Total hours 2
respondents respondent disclosures
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Declaration of Net Quantity of Contents 875 9 7,918 0.5 (30 minutes)...................... 3,959
Labeling for Nonprescription Drug Products--
Sec. 201.62.
Statement of Identity Labeling for 292 11.5 3,383 2.5................................... 8,457.5
Nonprescription Drug Products that are not
covered by a final OTC Drug Monograph under
section 505G of the FD&C Act--Sec. 201.61.
Additional Statement of Identity and Strength 292 11.5 3,383 2.5................................... 8,457.5
information in labeling of nonprescription
drug products that are not covered by a
final OTC Drug Monograph under section 505G
of the FD&C Act (Guidance For Industry
(GFI): Statement of Identity and Strength--
Content and Format of Labeling for Human
Nonprescription Drug Products, section III).
Additional Statement of Identity and Dosage 292 19 5,614 2.5................................... 14,035
Form information in labeling of
nonprescription drug products that are
covered by a final OTC Drug Monograph under
FD&C Act section 505G (GFI: Statement of
Identity and Strength--Content and Format of
Labeling for Human Nonprescription Drug
Products, section III).
DFL for Nonprescription Drug Products--Sec. 875 9 7,918 12.................................... 95,016
201.66(c) and (d) (including content within
DFL described in Sec. Sec. 201.21(b),
201.63(a), 201.64(b), 201.70(b), 201.71(b),
201.72(b), or in guidance)..
Address and phone number of responsible 300 3 900 4..................................... 3,600
person added to labeling for nonprescription
drug products marketed without an
application approved under section 502(x) of
the FD&C Act and GFI: Labeling of
Nonprescription Human Drug Products Marketed
Without an Approved Application as Required
by the Dietary Supplement and
Nonprescription Drug Consumer Protection
Act: Q&A--section III).
Total.................................... .............. ................. .............. ...................................... 133,525
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.
Table 2--Estimated Annual Third-Party Reporting Burden for OTC Drug Products 1
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Number of
Information collection activity--labeling Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
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Requests for exemptions/deferrals of OTC drug product Drug Facts 1 1 1 24 24
labeling requirements--Sec. 201.66(e)...........................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
II. OTC Monograph Drug User Fee Program Submissions
This information collection also includes submissions associated
with the OTC Monograph Drug User Fee Program. Section 744M of the FD&C
Act (21 U.S.C. 379j-72) establishes an OTC monograph drug user fee
program (commonly called OMUFA) and authorizes FDA to assess and
collect: (1) facility fees from qualifying OTC monograph drug
facilities and (2) fees from submitters of qualifying OTC Monograph
Order Requests (OMORs). The OMUFA program supports FDA activities
related to the regulation of OTC monograph drug products, including
provisions of section 505G of the FD&C Act that facilitate innovation
and make it easier for FDA to better respond to safety issues when they
emerge. We provide information regarding the OMUFA program on our
website at <a href="https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-user-fee-program-omufa">https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-user-fee-program-omufa</a>.
[[Page 76203]]
We developed Form FDA 5009, Over-The-Counter Monograph User Fee
Cover Sheet, (available at <a href="https://www.fda.gov/about-fda/reports-manuals-forms/forms">https://www.fda.gov/about-fda/reports-manuals-forms/forms</a>, Search for Form FDA 5009) to facilitate the
submission of OMUFA fees and to more efficiently administer the OMUFA
program. Form FDA 5009 provides FDA with necessary information to
determine the total user fee payment amount required and to help the
Agency track payments. Respondents to this collection are qualifying
finished dosage form manufacturers of OTC monograph drugs and
submitters of qualifying OMORs submitted under section 505G(b)(5) of
the FD&C Act.
In the Federal Register of September 9, 2022 (87 FR 55440) we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of the collection of information as follows:
Table 3--Estimated Annual OMUFA Reporting Burden \1\
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Number of
Form FDA 5009--OMUFA cover sheet Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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Submission associated with facility fees...... 1,184 1 1,184 0.5 (30 minutes)........................ 592
Submission associated with fees for qualifying 5 1 5 0.5 (30 minutes)........................ 2.5
OMORs.
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Total..................................... .............. .............. .............. ........................................ 594.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on data from our electronic Drug Registration and Listing
System, we estimate that there will be 1,184 respondents who will
provide information in conjunction with facility fee payments annually.
In addition, consistent with the ``Over-the-Counter Monograph User
Program Performance Goals and Procedures'' commitment letter (available
at <a href="https://www.fda.gov/media/106407/download">https://www.fda.gov/media/106407/download</a>), we estimate submitters
will provide the user fee information using Form FDA 5009 in
conjunction with an average of five qualifying OMORs annually. We
assume the user fee-related submissions will require an average of 30
minutes to prepare, for a total of 594.5 hours annually.
Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27016 Filed 12-12-22; 8:45 am]
BILLING CODE 4164-01-P
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