Agency Information Collection Activities; Proposed Collection; Comment Request; General Drug Labeling Provisions and Over-the-Counter Monograph Drug User Fee Submissions, 55440-55444 [2022-19502]
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Federal Register / Vol. 87, No. 174 / Friday, September 9, 2022 / Notices
Information Collection Activities;
Proposed Collection; Comment Request;
General Drug Labeling Provisions and
Over-the-Counter Monograph Drug User
Fee Submissions.’’ The proposed
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). As required by the PRA,
FDA has published an analysis of these
information collection provisions
elsewhere in this edition of the Federal
Register and will submit them for OMB
approval following the period for public
comment. This draft guidance also
refers to previously approved
collections of information found in FDA
regulations. The collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: September 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–19500 Filed 9–8–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–1794]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; General Drug
Labeling Provisions and Over-theCounter Monograph Drug User Fee
Submissions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
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SUMMARY:
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response to the notice. This notice
solicits comments on information
collections related to general drug
product labeling and to over-the-counter
(OTC) Monograph Drug User Fee
(OMUFA) submissions.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
November 8, 2022.
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 8, 2022. 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:
• 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.
• 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
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identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2022–N–1794 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; General
Drug Labeling Provisions and OTC
Monograph Drug User Fee
Submissions.’’ 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-201509-18/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
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White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
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.
SUPPLEMENTARY INFORMATION:
General Drug Labeling Provisions and
OTC Monograph Drug User Fee
Submissions—21 CFR Part 201
OMB Control Number 0910–0340—
Revision
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I. 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. Although we are
including the information collection
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associated with section 502(x) in OMB
control number 0910–0340, we are
evaluating whether the placement of
that information collection is better
located in another approval.
The requirements and
recommendations contained in the
authority above 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 (thirdparty 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 § 201.62
(21 CFR 201.62)). They also must
include a statement of identity (see
§ 201.61 (21 CFR 201.61)).
Elsewhere in this issue of the Federal
Register, 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-sodiumpotassium-and-phosphorus-humanover-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 § 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
1 When final, this guidance will represent FDA’s
current thinking on this topic.
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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 selfselection of these products and in
subsequent identification of the
products after purchase.
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 § 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).
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
§ 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
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
§ 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
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(§ 201.21(b) (21 CFR 201.21(b))), sodium
(§ 201.64(b) (21 CFR 201.64(b))),
calcium (§ 201.70(b) (21 CFR
201.70(b))), magnesium (§ 201.71(b) (21
CFR 201.71(b))), and potassium
(§ 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’’, which FDA has made
available elsewhere in this edition of the
Federal Register 2 (available at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
quantitative-labeling-sodiumpotassium-and-phosphorus-humanover-counter-and-prescription-drug)
(Quantitative Sodium, Potassium, and
Phosphorus Labeling Guidance). This
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 §§ 201.64
and 201.72 for conveying information
about these substances in OTC drug
product labeling. The 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 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 guidance
with regard to OTC drug products are
included with our estimates for
preparing the DFL panel of labeling,
where this information appears.
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.
2 When final, this guidance will represent FDA’s
current thinking on this topic.
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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).
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.
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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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.
Our annualized estimate of burden
addresses new products and products
for which the DFL and/or net quantity
of contents otherwise change in a 12month 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.
D. Submissions To Request Exemptions
or Deferrals From OTC Drug Labeling
Requirements
FDA regulations in § 201.66(e)
authorize FDA to exempt or defer
specific requirements in § 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
§ 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
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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
citizen petition in accordance with
§ 10.30 (21 CFR 10.30). The submission
of citizen petitions under § 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.
We estimate the burden of this
collection of information as follows:
annually, the Agency will receive one
request for a waiver or exemption from
the drug labeling requirement.
In addition, § 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 § 201.63(a). To
request such an exemption, the
regulations call for submission of a
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN FOR NEW OTC DRUG PRODUCTS 1
Number of
disclosures
per
respondent
Number of
respondents
Information collection activity—labeling
Declaration of Net Quantity of Contents Labeling for
Nonprescription Drug Products—§ 201.62.
Statement of Identity Labeling for Nonprescription Drug
Products that are not covered by a final OTC Drug
Monograph under section 505G of the FD&C Act—
§ 201.61.
Additional Statement of Identity and Strength 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 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—§ 201.66(c) and
(d) (including content within DFL described in
§§ 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 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 ...........................................................................
Average
burden per
disclosure
Total annual
disclosures
Total hours
875
9
7,918
* 0.5 ..................
3,959
292
11.5
3,383
2.5 ....................
8,457.5
292
11.5
3,383
2.5 ....................
8,457.5
292
19
5,614
2.5 ....................
14,035
875
9
7,918
12 .....................
95,016
300
3
900
4 .......................
3,600
........................
........................
........................
...........................
133,525
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
* 30 minutes.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY REPORTING BURDEN FOR OTC DRUG PRODUCTS 1
Requests for exemptions/deferrals of OTC drug product
Drug Facts labeling requirements—§ 201.66(e) ..............
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1 There
Number of
disclosures
per
respondent
Number of
respondents
Information collection activity—labeling
1
Average
burden per
disclosure
Total annual
disclosures
1
1
Total hours
24
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
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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)
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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
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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-programomufa.
We developed Form FDA 5009, OverThe-Counter Monograph User Fee Cover
Sheet, (available at www.fda.gov/aboutfda/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.
We estimate the burden of collection
of information as follows:
TABLE 3—ESTIMATED ANNUAL OMUFA REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Form FDA 5009—OMUFA cover sheet
Average
burden per
response
Total annual
responses
Total hours
Submission associated with facility fees ...
Submission associated with fees for qualifying OMORs ..........................................
1,184
1
1,184
* 0.5
592
5
1
5
* 0.5
2.5
Total ....................................................
........................
........................
........................
..................................................
594.5
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
* 30 minutes.
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: September 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–19502 Filed 9–8–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jspears on DSK121TN23PROD with NOTICES
[Docket No. FDA–2021–D–0528]
Quantitative Labeling of Sodium,
Potassium, and Phosphorus for
Human Over-the-Counter and
Prescription Drug Products; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
VerDate Sep<11>2014
18:57 Sep 08, 2022
Jkt 256001
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Quantitative Labeling of Sodium,
Potassium, and Phosphorus for Human
Over-the-Counter and Prescription Drug
Products.’’ This draft guidance is
intended to assist industry in providing
information in labeling about the
quantities at which sodium, potassium,
and phosphorus as constituents of
active or inactive drug ingredients are
present in human over-the-counter
(OTC) and prescription drug products.
DATES: Submit either electronic or
written comments on the draft guidance
by November 8, 2022 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
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
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
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.
• 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 the Docket No. FDA–
2021–D–0528 for ‘‘Quantitative Labeling
of Sodium, Potassium, and Phosphorus
for Human Over-the-Counter and
Prescription Drugs.’’ Received
comments 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
E:\FR\FM\09SEN1.SGM
09SEN1
]]>Agencies
[Federal Register Volume 87, Number 174 (Friday, September 9, 2022)]
[Notices]
[Pages 55440-55444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19502]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1794]
Agency Information Collection Activities; Proposed Collection;
Comment Request; General Drug Labeling Provisions and Over-the-Counter
Monograph Drug User Fee Submissions
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 collections related to general drug
product labeling and to over-the-counter (OTC) Monograph Drug User Fee
(OMUFA) submissions.
DATES: Either electronic or written comments on the collection of
information must be submitted by November 8, 2022.
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 8, 2022. 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:
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.
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 the Docket No.
FDA-2022-N-1794 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; General Drug Labeling Provisions
and OTC Monograph Drug User Fee Submissions.'' 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
[[Page 55441]]
White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD
20852, 301-796-5733, [email protected].
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.
General Drug Labeling Provisions and OTC Monograph Drug User Fee
Submissions--21 CFR Part 201
OMB Control Number 0910-0340--Revision
I. 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. Although we are
including the information collection associated with section 502(x) in
OMB control number 0910-0340, we are evaluating whether the placement
of that information collection is better located in another approval.
The requirements and recommendations contained in the authority
above 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)).
Elsewhere in this issue of the Federal Register, 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.
---------------------------------------------------------------------------
\1\ When final, this guidance will represent FDA's current
thinking on this topic.
---------------------------------------------------------------------------
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).
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 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
[[Page 55442]]
(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'', which FDA has made
available elsewhere in this edition of the Federal Register \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 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 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 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 guidance with regard to OTC
drug products are included with our estimates for preparing the DFL
panel of labeling, where this information appears.
---------------------------------------------------------------------------
\2\ When final, this guidance will represent FDA's current
thinking on this topic.
---------------------------------------------------------------------------
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). 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.
---------------------------------------------------------------------------
\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))).
---------------------------------------------------------------------------
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.
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
[[Page 55443]]
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.
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Information collection activity--labeling Number of disclosures Total annual Average burden per disclosure Total hours
respondents per respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Declaration of Net Quantity of Contents Labeling 875 9 7,918 * 0.5................................. 3,959
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 Form 292 19 5,614 2.5................................... 14,035
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 person 300 3 900 4..................................... 3,600
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
* 30 minutes.
Table 2--Estimated Annual Third-Party Reporting Burden for OTC Drug Products \1\
----------------------------------------------------------------------------------------------------------------
Number of
Information collection activity-- Number of disclosures Total annual Average burden Total hours
labeling respondents per respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
Requests for exemptions/ 1 1 1 24 24
deferrals of OTC drug product
Drug Facts labeling
requirements--Sec. 201.66(e).
----------------------------------------------------------------------------------------------------------------
\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
[[Page 55444]]
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.
We developed Form FDA 5009, Over-The-Counter Monograph User Fee
Cover Sheet, (available at 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.
We estimate the burden of collection of information as follows:
Table 3--Estimated Annual OMUFA Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Form FDA 5009--OMUFA cover sheet Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission associated with facility fees.................. 1,184 1 1,184 * 0.5 592
Submission associated with fees for qualifying OMORs...... 5 1 5 * 0.5 2.5
---------------------------------------------------------------------------------------------
Total................................................. .............. .............. .............. ............................ 594.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
* 30 minutes.
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: September 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19502 Filed 9-8-22; 8:45 am]
BILLING CODE 4164-01-P
