National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 64542 [2019-25306]
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64542
Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Dear Health Care Provider
Letters: Improving Communication of
Important Safety Information
OMB Control Number 0910–0754—
Extension
This information collection supports
recommendations found in the Agency
guidance document entitled ‘‘Dear
Health Care Provider Letters: Improving
Communication of Important Safety
Information.’’ The guidance provides
instruction to industry and FDA staff on
the content and format of Dear Health
Care Provider (DHCP) letters. These
letters are sent by manufacturers or
distributors to health care providers to
communicate an important drug
warning, a change in prescribing
information, or a correction of
misinformation in prescription drug
promotional labeling or advertising. The
guidance is available from our website
at: https://www.fda.gov/media/79793/
download.
The guidance document gives specific
instruction on what should and should
not be included in DHCP letters. Some
DHCP letters have been too long, have
contained promotional material, or
otherwise have not met the goals set
forth in the applicable regulation (21
CFR 200.5). In some cases, health care
providers have not been aware of
important new information, and have
been unable to communicate it to
patients, because the letters’ content and
length have made it difficult to find the
relevant information. In addition, letters
have sometimes been sent for the wrong
reasons.
In addition to content and format
recommendations for each type of DHCP
letter, the guidance also includes
recommendations on consulting with
FDA on how to develop a DHCP letter,
when to send a letter, what type of letter
to send, and how to assess the letter’s
impact. Based on a review of FDA’s
Document Archiving, Reporting, and
Regulatory Tracking System for 2016—
2018, we identified 38 DHCP letters that
were sent by 24 distinct sponsors during
the 3-year timeframe. We estimate that
we will receive approximately 13 DHCP
letters annually from approximately 8
application holders. FDA professionals
familiar with DHCP letters, and with the
recommendations in the guidance,
estimate that it should take an
application holder approximately 100
hours to prepare and send DHCP letters
in accordance with the guidance.
In the Federal Register of August 19,
2019 (84 FR 42929), we published a 60day notice requesting public comment
on the proposed collection of
information. One comment was received
expressing the importance of
communicating safety information, for
which we are appreciative. No other
comments were received.
We estimate the annual reporting
burden of this collection of information
as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Type of activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Dear Health Care Provider Letters ......................................
8
1.625
13
100
1,300
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection, we have reduced our burden
estimate by 17 respondents with a
corresponding decrease in annual hours
by 1,200. We attribute the decrease to
the effectiveness of the guidance.
Dated: November 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25333 Filed 11–21–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
khammond on DSKJM1Z7X2PROD with NOTICES
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
VerDate Sep<11>2014
16:57 Nov 21, 2019
Jkt 250001
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Centers for AIDS Research
(P30) and Developmental Centers for AIDS
Research (P30).
Date: December 16–17, 2019.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Chelsea D. Boyd, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institutes of Health, NIAID, 5601
Fishers Lane, MSC–9823, Rockville, MD
20852–9834, 240–669–2081, chelsea.boyd@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
PO 00000
Frm 00090
Fmt 4703
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Dated: November 15, 2019.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–25306 Filed 11–21–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
Mental Health Special Emphasis Panel,
November 25, 2019, 11:00 a.m. to
November 25, 2019, 4:00 p.m., National
Institutes of Health Neuroscience Center
Building (NSC), 6001 Executive
Boulevard, Rockville, MD 20852, which
was published in the Federal Register
on November 14, 2019, 84 FR 61920.
This notice is to amend the date of the
NIMH HIV/AIDS Review meeting from
November 25, 2019, from 11:00 a.m.–
4:00 p.m. to December 17, 2019, from
1:00 p.m.–5:00 p.m. The meeting is
closed to the public.
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]]>Agencies
[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Page 64542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25306]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of
Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Allergy and Infectious
Diseases Special Emphasis Panel; Centers for AIDS Research (P30) and
Developmental Centers for AIDS Research (P30).
Date: December 16-17, 2019.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Chelsea D. Boyd, Ph.D., Scientific Review
Officer, Scientific Review Program, Division of Extramural
Activities, National Institutes of Health, NIAID, 5601 Fishers Lane,
MSC-9823, Rockville, MD 20852-9834, 240-669-2081,
[email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
Dated: November 15, 2019.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-25306 Filed 11-21-19; 8:45 am]
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