[Federal Register Volume 87, Number 238 (Tuesday, December 13, 2022)]
[Notices]
[Pages 76200-76203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quantitative-labeling-sodium-potassium-and-phosphorus-human-over-counter-and-prescription-drug) 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 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quantitative-labeling-sodium-potassium-and-phosphorus-human-over-counter-and-prescription-drug) (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 https://www.fda.gov/media/77411/download). 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 https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-user-fee-program-omufa.

[[Page 76203]]

    We developed Form FDA 5009, Over-The-Counter Monograph User Fee 
Cover Sheet, (available at https://www.fda.gov/about-fda/reports-manuals-forms/forms, 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 https://www.fda.gov/media/106407/download), 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