Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Drug Labeling Provisions and Over-the-Counter Monograph Drug User Fee Submissions, 76200-76203 [2022-27016]
Download as PDF
<![CDATA[
76200
Federal Register / Vol. 87, No. 238 / Tuesday, December 13, 2022 / Notices
Our estimated burden for the
information collection reflects an
overall increase of 1,217,800 hours. We
made this adjustment to correspond
with an observed increase in
submissions relating to medical devices
and an increase in respondents in the
medical device industry since last OMB
review and approval of the information
collection.
Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27023 Filed 12–12–22; 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; Submission for Office of
Management and Budget Review;
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) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by January 12,
2023.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0340. Also include
the FDA docket number found in
brackets in the heading of this
document.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
VerDate Sep<11>2014
16:56 Dec 12, 2022
Jkt 259001
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
General Drug Labeling Provisions and
OTC Monograph Drug User Fee
Submissions—21 CFR Part 201
OMB Control Number 0910–0340—
Revision
I. Over-the-Counter (OTC) Drug Product
Labeling
This information collection supports
implementation of general drug labeling
provisions, including certain OTC drug
product labeling requirements found in
FDA regulations in 21 CFR part 201 and
in section 502(x) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 352(x)), as well as OTC drug
product labeling recommendations
discussed in FDA guidance documents
enumerated below. The requirements
and recommendations contained in this
authority help ensure that OTC drug
product labeling includes information to
assist consumers with product selection
and with the safe and effective use of
products that protect the public health
from potential harm that could result
from the dissemination of false and
misleading statements regarding FDAregulated 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)).
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/
1 When final, this guidance will represent FDA’s
current thinking on this topic.
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
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
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) of the FD&C
Act.
B. OTC Drug and Prescription Drug
Facts Labeling
In addition to labeling that drug
companies provide on the principal
display panel, companies must also
comply with Agency regulations in
§ 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
E:\FR\FM\13DEN1.SGM
13DEN1
lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 238 / Tuesday, December 13, 2022 / Notices
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
(§ 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’’ 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
draft guidance document provides
content and formatting
recommendations for presenting
quantitative information about sodium,
potassium, and phosphorus that can
help firms comply with the
requirements under §§ 201.64 and
201.72 for conveying information about
these substances in OTC drug product
labeling. The draft guidance also
provides parallel recommendations for
drug companies to provide quantitative
information about phosphorus in OTC
drug product labeling. This quantitative
information about sodium, potassium,
and phosphorus helps patients who
need to limit their overall consumption
of any of these substances because of its
impact on underlying health conditions,
such as heart failure, hypertension, or
chronic kidney disease. Quantifying
these substances in drug labeling can
also help healthcare providers and
patients select drug products with lower
amounts of these substances when such
alternatives are available. The draft
2 When final, this guidance will represent FDA’s
current thinking on this topic.
VerDate Sep<11>2014
16:56 Dec 12, 2022
Jkt 259001
guidance recommends approaches to
improve consistency in the presentation
of this information, including clarifying
quantities per dosage unit and rounding
consistency. The information
collections addressed in the draft
guidance with regard to OTC drug
products are included with our
estimates for preparing the DFL panel of
labeling, where this information
appears.
The Quantitative Sodium, Potassium,
and Phosphorus Labeling Guidance also
recommends how drug firms can
provide quantitative information on
sodium, potassium, and phosphorus in
prescription drug labeling to help
patients who need to limit their overall
consumption of these substances.
Prescription drugs are not subject to the
OTC labeling regulations, but the
content and format of prescription drug
labeling is set forth in 21 CFR 201.56
and 201.57 and approved under OMB
control number 0910–0572. In the
guidance, FDA recommends that when
the recommended quantitative
information about sodium, potassium,
and phosphorus is included in
prescription drug labeling, it should be
presented within the DESCRIPTION
section of that labeling, following the
list of inactive ingredients. We estimate
that the recommendations of the
guidance regarding disclosing
quantitative information about sodium,
potassium, and phosphorus in
prescription drug labeling will have no
effect on the overall burden estimate for
prescription drug labeling as a whole,
which is addressed under OMB control
number 0910–0572.
Our estimate of burden for OTC drug
labeling that appears within the DFL
reflects several considerations. For those
OTC drug products that are marketed
pursuant to an application approved
under section 505 of the FD&C Act (21
U.S.C. 355), we assume a substantial
part of the burden of developing
labeling is addressed in the submission
of the new drug application, which
includes submission of the proposed
labeling. The information collections
associated with new drug applications
are approved under OMB control
number 0910–0001. For OTC drugs that
are legally marketed under section 505G
of the FD&C Act that do not have an
approved application under section 505
of the FD&C Act, a substantial part of
the DFL’s content, including applicable
Uses (Indications), Warnings, and
Directions, is established under section
505G, either by final administrative
orders or by section 505G(a)(3) of the
FD&C Act. Collections of information
made under section 505G of the FD&C
Act are exempt from the PRA.
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
76201
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.
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.
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))).
E:\FR\FM\13DEN1.SGM
13DEN1
76202
Federal Register / Vol. 87, No. 238 / Tuesday, December 13, 2022 / Notices
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
appear in labeling by § 201.63(a). To
request such an exemption, the
regulations call for submission of a
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.
In the Federal Register of September
9, 2022 (87 FR 55440) we published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
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, § 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
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN FOR NEW OTC DRUG PRODUCTS 1
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 ...............................................................................................
1
2
Number of
disclosures per
respondent
Number of
respondents
Information collection activity—labeling
Total
annual
disclosures
Average
burden per
disclosure
Total hours 2
875
9
7,918
0.5 (30 minutes) ......
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
There are no capital costs or operating and maintenance costs associated with this collection of information.
Numbers have been rounded.
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) ...................................................................................
1
I
1
I
1
Total
annual
disclosures
I
1
Average
burden per
disclosure
I
24
Total
hours
I
24
There are no capital costs or operating and maintenance costs associated with this collection of information.
II. OTC Monograph Drug User Fee
Program Submissions
lotter on DSK11XQN23PROD with NOTICES1
Number of
disclosures
per
respondent
Number of
respondents
Information collection activity—labeling
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
VerDate Sep<11>2014
16:56 Dec 12, 2022
Jkt 259001
authorizes FDA to assess and collect: (1)
facility fees from qualifying OTC
monograph drug facilities and (2) fees
from submitters of qualifying OTC
Monograph Order Requests (OMORs).
The OMUFA program supports FDA
activities related to the regulation of
OTC monograph drug products,
including provisions of section 505G of
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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/overcounter-monograph-user-fee-programomufa.
E:\FR\FM\13DEN1.SGM
13DEN1
Federal Register / Vol. 87, No. 238 / Tuesday, December 13, 2022 / Notices
We developed Form FDA 5009, OverThe-Counter Monograph User Fee Cover
Sheet, (available at https://www.fda.gov/
about-fda/reports-manuals-forms/forms,
Search for Form FDA 5009) to facilitate
the submission of OMUFA fees and to
more efficiently administer the OMUFA
program. Form FDA 5009 provides FDA
with necessary information to determine
the total user fee payment amount
required and to help the Agency track
payments. Respondents to this
collection are qualifying finished dosage
form manufacturers of OTC monograph
drugs and submitters of qualifying
OMORs submitted under section
505G(b)(5) of the FD&C Act.
76203
In the Federal Register of September
9, 2022 (87 FR 55440) we published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of the
collection of information as follows:
TABLE 3—ESTIMATED ANNUAL OMUFA REPORTING BURDEN 1
Number of
respondents
Form FDA 5009—OMUFA cover sheet
Total
annual
responses
Average
burden per
response
Total
hours
Submission associated with facility fees .....................................................
Submission associated with fees for qualifying OMORs ............................
1,184
5
1
1
1,184
5
0.5 (30 minutes) ......
0.5 (30 minutes) ......
592
2.5
Total .....................................................................................................
........................
........................
........................
..................................
594.5
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on data from our electronic
Drug Registration and Listing System,
we estimate that there will be 1,184
respondents who will provide
information in conjunction with facility
fee payments annually. In addition,
consistent with the ‘‘Over-the-Counter
Monograph User Program Performance
Goals and Procedures’’ commitment
letter (available at https://www.fda.gov/
media/106407/download), we estimate
submitters will provide the user fee
information using Form FDA 5009 in
conjunction with an average of five
qualifying OMORs annually. We assume
the user fee-related submissions will
require an average of 30 minutes to
prepare, for a total of 594.5 hours
annually.
Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2010–D–0319]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Dear Healthcare
Provider Letters: Improving
Communication of Important Safety
Information
AGENCY:
Improving Communication of
Important Safety Information—21 CFR
Part 200
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing that a proposed collection
of information has been submitted to the
SUMMARY:
VerDate Sep<11>2014
20:11 Dec 12, 2022
Jkt 259001
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by January 12,
2023.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0754. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2022–27016 Filed 12–12–22; 8:45 am]
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
OMB Control Number 0910–0754—
Extension
This information collection supports
Agency regulations and
recommendations found in associated
Agency guidance, as discussed below.
Under section 705 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 375), the Secretary of the
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
Department of Health and Human
Services (the Secretary) may require
dissemination of information for drugs
in situations that involve, in the
Secretary’s opinion, ‘‘imminent danger
to health, or gross deception of the
consumer.’’ Implementing regulations
are found in § 200.5 (21 CFR 200.5) and
outline the general provisions for ‘‘Dear
Healthcare Provider’’ (DHCP) letters that
manufacturers and distributors
disseminate about important drug
warnings, important prescribing
information, and important correction of
drug information. The regulations also
prescribe certain format and content
instructions regarding the dissemination
of covered information. Manufacturers
or distributors send DHCP letters to
physicians and other healthcare
providers to communicate an important
drug warning, a change in prescribing
information, or a correction of
misinformation in prescription drug
promotional labeling or advertising. We
developed the guidance document
entitled ‘‘Dear Healthcare Provider
Letters: Improving Communication of
Important Safety Information’’ (January
2014), available at https://www.fda.gov/
media/79793/download, to provide
instructions and recommendations to
respondents on implementing the
applicable requirements. All Agency
guidance documents are issued
consistent with our good guidance
practice regulations at 21 CFR 10.115.
In addition to the content and format
recommendations for each type of DHCP
letter, the guidance also includes
recommendations on consulting with
FDA on: (1) how to develop a DHCP
letter; (2) when to send a letter; (3) what
type of letter to send; and (4) how to
assess the letter’s impact.
In the Federal Register of June 24,
2022 (87 FR 37871), we published a 60day notice requesting public comment
E:\FR\FM\13DEN1.SGM
13DEN1
]]>Agencies
[Federal Register Volume 87, Number 238 (Tuesday, December 13, 2022)]
[Notices]
[Pages 76200-76203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27016]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1794]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; General Drug Labeling
Provisions and Over-the-Counter Monograph Drug User Fee Submissions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by January 12, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0340. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
General Drug Labeling Provisions and OTC Monograph Drug User Fee
Submissions--21 CFR Part 201
OMB Control Number 0910-0340--Revision
I. Over-the-Counter (OTC) Drug Product Labeling
This information collection supports implementation of general drug
labeling provisions, including certain OTC drug product labeling
requirements found in FDA regulations in 21 CFR part 201 and in section
502(x) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 352(x)), as well as OTC drug product labeling recommendations
discussed in FDA guidance documents enumerated below. The requirements
and recommendations contained in this authority help ensure that OTC
drug product labeling includes information to assist consumers with
product selection and with the safe and effective use of products that
protect the public health from potential harm that could result from
the dissemination of false and misleading statements regarding FDA-
regulated products. As described further below, the information
collection provisions of one guidance also apply to prescription drug
labeling.
A. Principal Display Panel Labeling
Certain information collection provisions address the labeling
(third-party disclosures) that drug companies provide on the principal
display panel of every OTC drug product in package form--the part of
that drug product's label that is most likely to be displayed or
examined in a retail sale setting (see 21 CFR 201.60). Information on
this panel supports consumers' product selection, as well as
identification after purchase. OTC drug product companies must include
a declaration of the net quantity of the OTC product contents on the
principal display panel (see Sec. 201.62 (21 CFR 201.62)). They also
must include a statement of identity (see Sec. 201.61 (21 CFR
201.61)).
FDA has made available a draft guidance for industry entitled
``Statement of Identity and Strength--Content and Format of Labeling
for Human Nonprescription Drug Products'' \1\ (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quantitative-labeling-sodium-potassium-and-phosphorus-human-over-counter-and-prescription-drug) that further addresses content and
format of statement of identity information and drug product strength
information to be included in the principal display panel labeling of
human nonprescription drug products. The guidance provides
recommendations to help manufacturers comply with statement of identity
labeling requirements under Sec. 201.61 and also provides a
recommended alternative to the statement required by that regulation to
provide consumers with consistent information about the active
ingredients, strength, and dosage form of the product. Consistent
information about the active ingredients, strength, and dosage form of
the product on the principal display panel may aid consumers in
comparing nonprescription drug products and assist consumers in
appropriate self-selection of these products and in subsequent
identification of the products after purchase.
---------------------------------------------------------------------------
\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) of the FD&C Act.
B. OTC Drug and Prescription Drug Facts Labeling
In addition to labeling that drug companies provide on the
principal display panel, companies must also comply with Agency
regulations in Sec. 201.66 (21 CFR 201.66), which requires standard
content elements and formatting for the ``Drug Facts'' labeling (DFL)
of all OTC drug products. This standardized labeling helps consumers
understand the information that appears on OTC drug products to help
ensure that consumers can use those products safely and effectively.
The use of consistent language in labeling headings and subheadings
helps consumers comprehend information, and consistent formatting helps
consumers more efficiently locate information.
The DFL is where OTC drug product labeling presents certain
specific, standardized content required or recommended under other
regulations
[[Page 76201]]
or guidance documents. For this reason, our burden estimates address
these information collections together. One such provision authorizes
the optional use of a symbol to convey warnings regarding use of an OTC
drug product while pregnant or breast-feeding (see Sec. 201.63(a) (21
CFR 201.63(a)). In addition, the DFL is where OTC drug product labeling
presents information (if applicable) on the quantity per dosage unit of
certain specific substances. Some consumers need to restrict their
total daily intake of these substances because of their impact on the
consumers' underlying health conditions. Specific quantitative
information must be presented in OTC drug product labeling for
phenylalanine/aspartame (Sec. 201.21(b) (21 CFR 201.21(b))), sodium
(Sec. 201.64(b) (21 CFR 201.64(b))), calcium (Sec. 201.70(b) (21 CFR
201.70(b))), magnesium (Sec. 201.71(b) (21 CFR 201.71(b))), and
potassium (Sec. 201.72(b) (21 CFR 201.72(b))).
The quantitative labeling requirements in those regulations cited
above are complemented by the draft guidance for industry entitled
``Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human
Over-the-Counter and Prescription Drug Products'' \2\ (available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quantitative-labeling-sodium-potassium-and-phosphorus-human-over-counter-and-prescription-drug) (Quantitative Sodium, Potassium,
and Phosphorus Labeling Guidance). This draft guidance document
provides content and formatting recommendations for presenting
quantitative information about sodium, potassium, and phosphorus that
can help firms comply with the requirements under Sec. Sec. 201.64 and
201.72 for conveying information about these substances in OTC drug
product labeling. The draft guidance also provides parallel
recommendations for drug companies to provide quantitative information
about phosphorus in OTC drug product labeling. This quantitative
information about sodium, potassium, and phosphorus helps patients who
need to limit their overall consumption of any of these substances
because of its impact on underlying health conditions, such as heart
failure, hypertension, or chronic kidney disease. Quantifying these
substances in drug labeling can also help healthcare providers and
patients select drug products with lower amounts of these substances
when such alternatives are available. The draft guidance recommends
approaches to improve consistency in the presentation of this
information, including clarifying quantities per dosage unit and
rounding consistency. The information collections addressed in the
draft guidance with regard to OTC drug products are included with our
estimates for preparing the DFL panel of labeling, where this
information appears.
---------------------------------------------------------------------------
\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) of the FD&C Act.
Collections of information made under section 505G of the FD&C Act are
exempt from the PRA. Therefore, labeling required by administrative
orders under section 505G of the FD&C Act or required by section
505G(a)(3) of the FD&C Act, even if it would ordinarily be a collection
of information,\3\ is exempt from the PRA and is not considered in our
burden estimate for the DFL (see section 505G(o) of the FD&C Act).
Finally, we note that the DFL of many individual products already being
marketed will remain unchanged within a given year. Thus, our
annualized burden estimate encompasses only new products or those
otherwise undergoing changes, such as reformulation, or changes in
package quantity that necessitate revisions to the DFL, whether those
products are marketed under approved applications (e.g., new drug
application/abbreviated new drug application) or pursuant to section
505G of the FD&C Act.
---------------------------------------------------------------------------
\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.
[[Page 76202]]
D. Submissions To Request Exemptions or Deferrals From OTC Drug
Labeling Requirements
FDA regulations in Sec. 201.66(e) authorize FDA to exempt or defer
specific requirements in Sec. 201.66 if FDA finds that the requirement
is inapplicable, impracticable, or contrary to public health or safety.
A manufacturer, packer, or distributor can seek such an exemption or
deferral by submitting a written request in accordance with the
requirements of Sec. 201.66(e), which address the content of such a
written request submission and how and where to submit it. A request
for an exemption or deferral must be submitted in triplicate for each
OTC drug product and contain certain information allowing the Agency to
make an informed decision on the request. FDA uses the submitted
information to assess whether the grounds for an exemption or deferral
are met. Based on historical experience and from feedback received from
respondents who have submitted similar requests, FDA estimates that it
will take 24 hours to prepare and submit each submission and that on
average annually, the Agency will receive one request for a waiver or
exemption from the drug labeling requirement.
In addition, Sec. 201.63(d) states that FDA may grant exemptions
from the specific OTC drug product warning for patients who are
pregnant or breast feeding that is ordinarily required to appear in
labeling by Sec. 201.63(a). To request such an exemption, the
regulations call for submission of a citizen petition in accordance
with Sec. 10.30 (21 CFR 10.30). The submission of citizen petitions
under Sec. 10.30, including those petitions that request this labeling
exemption, is approved under OMB control number 0910-0191, and we do
not address its burden further in this document.
In the Federal Register of September 9, 2022 (87 FR 55440) we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden for New OTC Drug Products 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Information collection activity--labeling Number of disclosures per Total annual Average burden per disclosure Total hours 2
respondents respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Declaration of Net Quantity of Contents 875 9 7,918 0.5 (30 minutes)...................... 3,959
Labeling for Nonprescription Drug Products--
Sec. 201.62.
Statement of Identity Labeling for 292 11.5 3,383 2.5................................... 8,457.5
Nonprescription Drug Products that are not
covered by a final OTC Drug Monograph under
section 505G of the FD&C Act--Sec. 201.61.
Additional Statement of Identity and Strength 292 11.5 3,383 2.5................................... 8,457.5
information in labeling of nonprescription
drug products that are not covered by a
final OTC Drug Monograph under section 505G
of the FD&C Act (Guidance For Industry
(GFI): Statement of Identity and Strength--
Content and Format of Labeling for Human
Nonprescription Drug Products, section III).
Additional Statement of Identity and Dosage 292 19 5,614 2.5................................... 14,035
Form information in labeling of
nonprescription drug products that are
covered by a final OTC Drug Monograph under
FD&C Act section 505G (GFI: Statement of
Identity and Strength--Content and Format of
Labeling for Human Nonprescription Drug
Products, section III).
DFL for Nonprescription Drug Products--Sec. 875 9 7,918 12.................................... 95,016
201.66(c) and (d) (including content within
DFL described in Sec. Sec. 201.21(b),
201.63(a), 201.64(b), 201.70(b), 201.71(b),
201.72(b), or in guidance)..
Address and phone number of responsible 300 3 900 4..................................... 3,600
person added to labeling for nonprescription
drug products marketed without an
application approved under section 502(x) of
the FD&C Act and GFI: Labeling of
Nonprescription Human Drug Products Marketed
Without an Approved Application as Required
by the Dietary Supplement and
Nonprescription Drug Consumer Protection
Act: Q&A--section III).
Total.................................... .............. ................. .............. ...................................... 133,525
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.
Table 2--Estimated Annual Third-Party Reporting Burden for OTC Drug Products 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Information collection activity--labeling Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requests for exemptions/deferrals of OTC drug product Drug Facts 1 1 1 24 24
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 activities
related to the regulation of OTC monograph drug products, including
provisions of section 505G of the FD&C Act that facilitate innovation
and make it easier for FDA to better respond to safety issues when they
emerge. We provide information regarding the OMUFA program on our
website at https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-user-fee-program-omufa.
[[Page 76203]]
We developed Form FDA 5009, Over-The-Counter Monograph User Fee
Cover Sheet, (available at https://www.fda.gov/about-fda/reports-manuals-forms/forms, Search for Form FDA 5009) to facilitate the
submission of OMUFA fees and to more efficiently administer the OMUFA
program. Form FDA 5009 provides FDA with necessary information to
determine the total user fee payment amount required and to help the
Agency track payments. Respondents to this collection are qualifying
finished dosage form manufacturers of OTC monograph drugs and
submitters of qualifying OMORs submitted under section 505G(b)(5) of
the FD&C Act.
In the Federal Register of September 9, 2022 (87 FR 55440) we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of the collection of information as follows:
Table 3--Estimated Annual OMUFA Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 (30 minutes)........................ 592
Submission associated with fees for qualifying 5 1 5 0.5 (30 minutes)........................ 2.5
OMORs.
------------------------------------------------ ---------------
Total..................................... .............. .............. .............. ........................................ 594.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on data from our electronic Drug Registration and Listing
System, we estimate that there will be 1,184 respondents who will
provide information in conjunction with facility fee payments annually.
In addition, consistent with the ``Over-the-Counter Monograph User
Program Performance Goals and Procedures'' commitment letter (available
at https://www.fda.gov/media/106407/download), we estimate submitters
will provide the user fee information using Form FDA 5009 in
conjunction with an average of five qualifying OMORs annually. We
assume the user fee-related submissions will require an average of 30
minutes to prepare, for a total of 594.5 hours annually.
Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27016 Filed 12-12-22; 8:45 am]
BILLING CODE 4164-01-P
