Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Dear Healthcare Provider Letters: Improving Communication of Important Safety Information, 76203-76204 [2022-27012]
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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
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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
76204
Federal Register / Vol. 87, No. 238 / Tuesday, December 13, 2022 / Notices
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 REPORTING BURDEN 1
Activity; 21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average time
per response
(in hours)
Total hours
Preparation of DHCP letters; § 200.5 ..................................
6
1.3
8
100
800
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We have identified 24 DHCP letters
that 18 distinct sponsors submitted to
FDA during the 3-year period (2019 to
2021). Based on our Document
Archiving, Reporting, and Regulatory
Tracking System, we estimate eight
DHCP letters will be submitted annually
from six application holders. Based on
our experience, we assume that each
letter will require 100 hours to prepare
and disseminate as recommended in the
guidance. Our estimate reflects a
downward adjustment by five responses
and 500 hours annually. We attribute
this decrease to the effectiveness of the
guidance and the decreased number of
DHCP letters submitted for FDA review.
Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27012 Filed 12–12–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; The Teaching Health Center
Graduate Medical Education Program
Reconciliation Tool, OMB No. 0915–
0342—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
16:56 Dec 12, 2022
Jkt 259001
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than February 13,
2023.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Samantha Miller, the HRSA
Information Collection Clearance Officer
at (301) 594–4394.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
The Teaching Health Center Graduate
Medical Education (THCGME) Program
Reconciliation Tool OMB No. 0915–
0342— Revision
Abstract: The THCGME program,
authorized by Section 340H of the
Public Health Service Act, was
established by Section 5508 of Public
Law 111–148. The Consolidated
Appropriations Act, 2021 (Pub. L. 116–
260) and the American Rescue Plan Act
of 2021 (Pub. L. 117–2) provide
continued funding for the THCGME
Program.
The THCGME program awards
payment for both direct and indirect
expenses to support training for primary
care residents in community-based
ambulatory patient care settings. Direct
expense payments are designed to
compensate eligible teaching health
centers for those expenses directly
associated with sponsoring resident
training programs, while indirect
expense payments are intended to
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Frm 00031
Fmt 4703
Sfmt 4703
compensate for the additional costs
relating to teaching residents in such
programs.
HRSA collects information from
THCGME program award recipients
using an OMB-approved reconciliation
tool. HRSA seeks to extend its approved
information collection and is increasing
the total estimated annual burden hours
associated with the collection, due to an
increase in the number of program
award recipients from 58 to 83.
Need and Proposed Use of the
Information: THCGME program
payments are prospective payments,
and the statute provides for a
reconciliation process, through which
overpayments may be recouped and
underpayments may be adjusted at the
end of the fiscal year. This data
collection instrument will gather
information relating to the number of
resident full-time equivalents in
Teaching Health Center training
programs in order to reconcile payments
for both direct and indirect expenses.
Likely Respondents: The likely
respondents to the THCGME
Reconciliation Tool are THCGME
program award recipients.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
E:\FR\FM\13DEN1.SGM
13DEN1
]]>Agencies
[Federal Register Volume 87, Number 238 (Tuesday, December 13, 2022)]
[Notices]
[Pages 76203-76204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27012]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[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: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, 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 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: 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.
Improving Communication of Important Safety Information--21 CFR Part
200
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 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 Sec. 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 60-day notice requesting public comment
[[Page 76204]]
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 Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average time
Activity; 21 CFR section Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparation of DHCP letters; Sec. 200.5.......................... 6 1.3 8 100 800
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We have identified 24 DHCP letters that 18 distinct sponsors
submitted to FDA during the 3-year period (2019 to 2021). Based on our
Document Archiving, Reporting, and Regulatory Tracking System, we
estimate eight DHCP letters will be submitted annually from six
application holders. Based on our experience, we assume that each
letter will require 100 hours to prepare and disseminate as recommended
in the guidance. Our estimate reflects a downward adjustment by five
responses and 500 hours annually. We attribute this decrease to the
effectiveness of the guidance and the decreased number of DHCP letters
submitted for FDA review.
Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27012 Filed 12-12-22; 8:45 am]
BILLING CODE 4164-01-P
