Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Records and Reports Concerning Experiences With Approved New Animal Drugs: Adverse Event Reports, 26318-26320 [2023-08999]
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<![CDATA[
26318
Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices
a 60-day notice requesting public
comment on the proposed collection of
information. FDA received no
comments.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Study 1
Study 1 Pretest Screener Completes ..........................
Study 1 Pretest Questionnaire Completes ..................
Number of
responses per
respondent
Study 2 Pretest Screener Completes ..........................
Study 2 Pretest Questionnaire Completes ..................
Study 1 Main Study Screener Completes ...................
Study 1 Main Study Questionnaire Completes ...........
630
126
.03 (2 minutes) ......
.30 (18 minutes) .....
18.9
38
1
1
420
126
.03 (2 minutes) ......
.30 (18 minutes) .....
12.6
38
1
1
3,240
648
.03 (2 minutes) .......
.30 (18 minutes) .....
97.2
194
Main Study
3,240
648
Study 2
1
1
Pretest
420
126
Study 1
Total hours
Pretest
630
126
Study 2
Average burden
per response
(in hours) 2
Total annual
responses
Main Study
Study 2 Main Study Screener Completes ...................
Study 2 Main Study Questionnaire Completes ...........
2,160
648
1
1
2,160
648
.03 (2 minutes) .......
.30 (18 minutes) .....
64.8
194
Total ......................................................................
........................
........................
........................
................................
657.50
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60.’’
2 Burden
ddrumheller on DSK120RN23PROD with NOTICES1
References
The following references marked with
an asterisk (*) are on display at the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852 and are available for viewing by
interested persons between 9 a.m. and 4
p.m., Monday through Friday; they also
are available electronically at https://
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff. FDA
has verified the website addresses, as of
the date this document publishes in the
Federal Register, but websites are
subject to change over time.
1. LaTour, C. and M. Smith, ‘‘A Study of
Expert Endorsement of OTC
Pharmaceutical Products,’’ Journal of
Pharmaceutical Marketing &
Management, Vol. 1, Issue 2, pp. 117–
128, 1986.
2. Bhutada, N.S. and B.L. Rollins, ‘‘DiseaseSpecific Direct-to-Consumer Advertising
of Pharmaceuticals: An Examination of
Endorser Type and Gender Effects on
Consumers’ Attitudes and Behaviors,’’
Research in Social and Administrative
Pharmacy, Vol. 11, Issue 6, pp. 891–900,
2015.
3. *Pharmaceutical Research and
Manufacturers of America (PhRMA),
‘‘PhRMA Guiding Principles: Direct to
VerDate Sep<11>2014
18:44 Apr 27, 2023
Jkt 259001
Consumer Advertisements About
Prescription Medicines,’’
Pharmaceutical Research and
Manufacturers of America, Washington,
DC, https://www.phrma.org, revised
October 2018, available at https://
phrma.org/-/media/Project/PhRMA/
PhRMA-Org/PhRMA-Org/PDF/P-R/
PhRMA_Guiding_Principles_2018.pdf
(accessed May 18, 2022).
4. *Schouten, A.P., L. Janssen, and M.
Verspaget, ‘‘Celebrity vs. Influencer
Endorsements in Advertising: The Role
of Identification, Credibility, and
Product-Endorser Fit,’’ International
Journal of Advertising, Vol. 39, Issue 2,
pp. 258–281, 2020, https://doi.org/
10.1080/02650487.2019.1634898.
5. *Bulik, B.S., ‘‘Merck Adds Real Patient to
‘TRU’ Keytruda TV Ad,’’ Fierce Pharma,
September 27, 2017, available at https://
www.fiercepharma.com/marketing/newmerck-tv-ad-for-keytruda-continues-trutheme-but-now-features-real-patient
(accessed May 18, 2022).
Dated: April 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–08965 Filed 4–27–23; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00070
Fmt 4703
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–3208]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Records and
Reports Concerning Experiences With
Approved New Animal Drugs: Adverse
Event Reports
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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 May 30,
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
SUMMARY:
E:\FR\FM\28APN1.SGM
28APN1
Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices
control number for this information
collection is 0910–0284. 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, PRAStaff@
fda.hhs.gov.
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:
Records and Reports Concerning
Experiences With Approved New
Animal Drugs: Adverse Event Reports
OMB Control Number 0910–0284—
Extension
This information collection supports
statutory and regulatory requirements
governing reporting associated with
certain animal drug products. With
regard to adverse events and product/
manufacturing defects associated with
approved new animal drugs, section
512(l) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(l))
requires applicants with approved new
animal drug applications (NADAs) and
abbreviated new animal drug
applications (ANADAs) to establish and
maintain records and reports of data
relating to experience with uses of such
drug, or with respect to animal feeds
bearing or containing such drug, to
facilitate a determination under section
512(e) as to whether there may be
grounds for suspending or withdrawing
approval of the NADA or ANADA under
section 512(e) or 512(m)(4).
In 2020, FDA amended § 514.80 (21
CFR 514.80) to require electronic
submission of certain postmarketing
safety reports for approved new animal
drugs and to provide a procedure for
requesting a temporary waiver of the
requirement. We, therefore, retain use of
certain paper-based forms. Section
514.80 requires applicants and
nonapplicants to keep records of and
report to us data, studies, and other
information concerning experience with
new animal drugs for each approved
NADA and ANADA. Following
complaints from animal owners or
veterinarians, or following their own
detection of a problem, applicants or
nonapplicants are required to submit
adverse event reports and product/
manufacturing defect reports under
§ 514.80(b)(1), (b)(2)(i) and (ii), (b)(3),
and (b)(4)(iv)(A) and (C) on Form FDA
1932.
The information collection includes
electronic submission of adverse event
reports and product/manufacturing
defect reports under § 514.80(b)(1),
26319
(b)(2)(i) and (ii), (b)(3), and (b)(4)(iv)(A)
and (C) using Form FDA 1932. The
information collection also includes
submissions under § 514.80(d)(2), by an
applicant or nonapplicant requesting, in
writing, a temporary waiver of the
electronic submission requirements.
The initial request may be by telephone
or email to the Center for Veterinary
Medicine’s Division of
Pharmacovigilance and Surveillance,
with prompt written followup
submitted as a letter to the
application(s). FDA will grant waivers
on a limited basis for good cause shown.
If FDA grants a waiver, the applicant or
nonapplicant must comply with the
conditions for reporting specified by
FDA upon granting the waiver.
Description of Respondents:
Respondents to this collection of
information are applicants and
nonapplicants as defined in 21 CFR
514.3. Respondents include individuals
and the private sector (for-profit
businesses).
In the Federal Register of December
22, 2022 (87 FR 78694) FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. Although one comment
was received it was not responsive to
any of the four information collection
topics solicited in our notice.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
FDA form No.
Medicated feed reports, 510.301(a)
and (b).
Submission of postmarketing safety
reports under § 514.80(b)(1), (2)(i)
and (ii), (3) , and (4)(iv)(A) and (C).
Voluntary reporting FDA Form 1932a
for the public.
514.80(b)(4) Periodic Drug Experience Reports.
514.80(b)(5)(i) Special Drug Experience Reports.
514.80(b)(5)(ii) Advertisement and
Promotional labeling.
514.80(b)(5)(iii) Distributor’s Statements.
514.80(d)(2) .......................................
ddrumheller on DSK120RN23PROD with NOTICES1
Total ...........................................
1 There
Number of
responses per
respondent
Number of
respondents
Total annual
responses
Average burden
per response
Total hours
N/A
8
1
8
0.25 (15 minutes)
2
1932
85
1,249
98,639
1 ...........................
98,639
1932a
106
1
106
1 ...........................
106
2301
79
20
1,582
16 .........................
25,312
2301
78
215
16,790
2 ...........................
33,580
2301
38
192
7,282
2 ...........................
14,564
2301
22
2
36
2 ...........................
72
N/A
1
1
1
1 ...........................
1
........................
........................
........................
........................
..............................
172,276
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Recordkeeping, 510.301 2 .............................................
VerDate Sep<11>2014
18:44 Apr 27, 2023
Jkt 259001
PO 00000
Frm 00071
Number of
records per
recordkeeper
8
Fmt 4703
Total annual
records
1
Sfmt 4703
E:\FR\FM\28APN1.SGM
Average burden
per recordkeeping
8
4 ...........................
28APN1
Total hours
32
26320
Federal Register / Vol. 88, No. 82 / Friday, April 28, 2023 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
Recordkeeping, 21 U.S.C. 360b(1) and 514.80(e) 3 .....
79
1,575.14
124,436
14 .........................
1,742,104
Total .......................................................................
........................
........................
........................
..............................
1,742,136
1 There
2 This
3 This
are no capital costs or operating and maintenance costs associated with this collection of information.
estimate includes all recordkeeping by licensed medicated feed manufacturers under § 510.301.
estimate includes all recordkeeping by applicants of approved NADAs, ANADAs, and conditional NADAs under § 514.80(e).
Upon review of the information
collection, we have adjusted our
estimated burden to reflect an overall
increase of 136,029.75 hours and
1,677,019 responses/records, annually.
Dated: April 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–08999 Filed 4–27–23; 8:45 am]
BILLING CODE 4164–01–P
Federal-State Food Regulatory Program
Standards
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0341]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Federal-State Food
Regulatory Program Standards
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 May 30,
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 0910–0760. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:44 Apr 27, 2023
Jkt 259001
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
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.
OMB Control Number 0910–0760—
Revision
This information collection supports
the FDA’s Animal Food (formerly Feed)
Regulatory Program Standards (AFRPS)
and Egg Regulatory Program Standards
(ERPS). In the United States, Federal
and State government agencies ensure
the safety of human and animal food.
FDA is responsible for ensuring that all
human and animal food moving in
interstate commerce, except those under
the U.S. Department of Agriculture
jurisdiction, are safe, wholesome, and
labeled properly. States are responsible
for conducting inspections and
regulatory activities that help ensure
human and animal food produced,
processed, and distributed within their
jurisdictions are safe and in compliance
with State laws and regulations. States
primarily perform inspections under
their own regulatory authority. Some
States conduct inspections of human
and animal food facilities under
contract with FDA. Because
jurisdictions may overlap, FDA and
States collaborate and share resources to
protect human and animal food.
The FDA Food Safety Modernization
Act calls for enhanced partnerships and
provides a legal mandate for developing
an Integrated Food Safety System
(IFSS). FDA is committed to
implementing an IFSS thereby
optimizing coordination of human and
animal food safety efforts with Federal,
State, local, tribal, and territorial
regulatory and public health agencies.
Model standards provide a consistent,
underlying foundation that is critical for
uniformity across State and Federal
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
agencies to ensure credibility of human
and animal food programs within the
IFSS. The AFRPS and ERPS provide a
uniform and consistent approach to
animal food and egg regulation in the
United States. Implementation is
voluntary.
The AFRPS and ERPS are the
frameworks that each State should use
to design, manage, and improve its
animal food or egg regulatory program.
Each standard has a purpose statement,
requirement summary, description of
program elements, projected outcomes,
and a list of required documentation.
When a state program voluntarily agrees
to implement the standards, it must
fully implement and maintain the
individual program elements and
documentation requirements in each
standard in order to fully implement the
standard. We invite you to visit our
website (https://www.fda.gov/federalstate-local-tribal-and-territorialofficials/national-integrated-food-safetysystem-ifss-programs-and-initiatives/
regulatory-programstandards#:∼:text=Regulatory%20
program%20standards%20establish
%20a,regulating%20human
%20and%20animal%20food) for more
information and to access the program
standards.
Both the AFRPS and ERPS packages
include forms, worksheets, and
templates to help the State program
assess and meet the program elements
in the standard. State programs are not
obligated to use the forms, worksheets,
and templates. Other manual or
automated forms, worksheets, and
templates may be used as long as the
pertinent data elements are present.
States submit the information collected
annually via email to the appropriate
FDA program manager. Records and
other documents specified in the AFRPS
and ERPS must be maintained in good
order by the state program and must be
available to verify the implementation
of each standard.
As set forth in the AFRPS and ERPS,
the state program is expected to review
and update its improvement plan on an
annual basis. The state program
completes an evaluation of its
E:\FR\FM\28APN1.SGM
28APN1
]]>Agencies
[Federal Register Volume 88, Number 82 (Friday, April 28, 2023)]
[Notices]
[Pages 26318-26320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08999]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-3208]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Records and Reports
Concerning Experiences With Approved New Animal Drugs: Adverse Event
Reports
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) 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 May 30, 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
[[Page 26319]]
control number for this information collection is 0910-0284. 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.
Records and Reports Concerning Experiences With Approved New Animal
Drugs: Adverse Event Reports
OMB Control Number 0910-0284--Extension
This information collection supports statutory and regulatory
requirements governing reporting associated with certain animal drug
products. With regard to adverse events and product/manufacturing
defects associated with approved new animal drugs, section 512(l) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(l)) requires
applicants with approved new animal drug applications (NADAs) and
abbreviated new animal drug applications (ANADAs) to establish and
maintain records and reports of data relating to experience with uses
of such drug, or with respect to animal feeds bearing or containing
such drug, to facilitate a determination under section 512(e) as to
whether there may be grounds for suspending or withdrawing approval of
the NADA or ANADA under section 512(e) or 512(m)(4).
In 2020, FDA amended Sec. 514.80 (21 CFR 514.80) to require
electronic submission of certain postmarketing safety reports for
approved new animal drugs and to provide a procedure for requesting a
temporary waiver of the requirement. We, therefore, retain use of
certain paper-based forms. Section 514.80 requires applicants and
nonapplicants to keep records of and report to us data, studies, and
other information concerning experience with new animal drugs for each
approved NADA and ANADA. Following complaints from animal owners or
veterinarians, or following their own detection of a problem,
applicants or nonapplicants are required to submit adverse event
reports and product/manufacturing defect reports under Sec.
514.80(b)(1), (b)(2)(i) and (ii), (b)(3), and (b)(4)(iv)(A) and (C) on
Form FDA 1932.
The information collection includes electronic submission of
adverse event reports and product/manufacturing defect reports under
Sec. 514.80(b)(1), (b)(2)(i) and (ii), (b)(3), and (b)(4)(iv)(A) and
(C) using Form FDA 1932. The information collection also includes
submissions under Sec. 514.80(d)(2), by an applicant or nonapplicant
requesting, in writing, a temporary waiver of the electronic submission
requirements. The initial request may be by telephone or email to the
Center for Veterinary Medicine's Division of Pharmacovigilance and
Surveillance, with prompt written followup submitted as a letter to the
application(s). FDA will grant waivers on a limited basis for good
cause shown. If FDA grants a waiver, the applicant or nonapplicant must
comply with the conditions for reporting specified by FDA upon granting
the waiver.
Description of Respondents: Respondents to this collection of
information are applicants and nonapplicants as defined in 21 CFR
514.3. Respondents include individuals and the private sector (for-
profit businesses).
In the Federal Register of December 22, 2022 (87 FR 78694) FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received it was not
responsive to any of the four information collection topics solicited
in our notice.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section FDA form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medicated feed reports, 510.301(a) and N/A 8 1 8 0.25 (15 minutes)............... 2
(b).
Submission of postmarketing safety 1932 85 1,249 98,639 1............................... 98,639
reports under Sec. 514.80(b)(1),
(2)(i) and (ii), (3) , and (4)(iv)(A)
and (C).
Voluntary reporting FDA Form 1932a for 1932a 106 1 106 1............................... 106
the public.
514.80(b)(4) Periodic Drug Experience 2301 79 20 1,582 16.............................. 25,312
Reports.
514.80(b)(5)(i) Special Drug 2301 78 215 16,790 2............................... 33,580
Experience Reports.
514.80(b)(5)(ii) Advertisement and 2301 38 192 7,282 2............................... 14,564
Promotional labeling.
514.80(b)(5)(iii) Distributor's 2301 22 2 36 2............................... 72
Statements.
514.80(d)(2).......................... N/A 1 1 1 1............................... 1
-----------------------------------------------------------------------------------------------------------------
Total............................. .............. .............. .............. .............. ................................ 172,276
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping, 510.301 \2\.................... 8 1 8 4....................................... 32
[[Page 26320]]
Recordkeeping, 21 U.S.C. 360b(1) and 514.80(e) 79 1,575.14 124,436 14...................................... 1,742,104
\3\.
---------------------------------------------------------------------------------------------------------
Total..................................... .............. .............. .............. ........................................ 1,742,136
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ This estimate includes all recordkeeping by licensed medicated feed manufacturers under Sec. 510.301.
\3\ This estimate includes all recordkeeping by applicants of approved NADAs, ANADAs, and conditional NADAs under Sec. 514.80(e).
Upon review of the information collection, we have adjusted our
estimated burden to reflect an overall increase of 136,029.75 hours and
1,677,019 responses/records, annually.
Dated: April 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08999 Filed 4-27-23; 8:45 am]
BILLING CODE 4164-01-P
