[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]


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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.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed revision of an existing collection of information, and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on information 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.
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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).

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.
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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). 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.

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\
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                                                                     Number of
    Information collection activity--labeling        Number of      disclosures    Total annual        Average burden per disclosure        Total hours
                                                    respondents   per respondent    disclosures
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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
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\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\
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                                                     Number of
Information collection activity--    Number of      disclosures    Total annual   Average burden    Total hours
            labeling                respondents   per respondent    disclosures   per disclosure
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Requests for exemptions/                       1               1               1              24              24
 deferrals of OTC drug product
 Drug Facts 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

[[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\
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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             592
Submission associated with fees for qualifying OMORs......               5               1               5                         * 0.5             2.5
                                                           ---------------------------------------------------------------------------------------------
    Total.................................................  ..............  ..............  ..............  ............................           594.5
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\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


