Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information, 72808-72809 [2016-25481]
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72808
Federal Register / Vol. 81, No. 204 / Friday, October 21, 2016 / Notices
State
Grantee
New Hampshire ........................................
New Jersey ...............................................
New Mexico ..............................................
New York ..................................................
North Carolina ...........................................
North Dakota .............................................
Ohio ..........................................................
Oregon ......................................................
Pennsylvania .............................................
Rhode Island .............................................
South Dakota ............................................
Tennessee ................................................
Texas ........................................................
Utah ..........................................................
Vermont ....................................................
Virginia ......................................................
Washington ...............................................
Wisconsin ..................................................
NH. Dept. of Health & Human Services ......................................................................
New Jersey Department of Human Services ..............................................................
New Mexico Human Services Department ..................................................................
NY Office of Temporary and Disability Assistance ......................................................
North Caroline Dept. of Health & Human Services .....................................................
North Dakota Department of Public Instruction ...........................................................
Ohio Department of Job and Family Services .............................................................
Lutheran Community Services Northwest ...................................................................
Commonwealth of Pennsylvania ..................................................................................
Rhode Island Department of Human Services ............................................................
Lutheran Social Services of South Dakota ..................................................................
Catholic Charities of Tennessee, Inc. ..........................................................................
Texas Health and Human Services Commission ........................................................
Utah Department of Workforce Services .....................................................................
Vermont Agency of Human Services ...........................................................................
Virginia Department of Social Services .......................................................................
WA State Department of Social & Health Services .....................................................
Wisconsin Department of Public Instruction ................................................................
25,736
25,736
25,736
171,426
84,000
25,736
73,746
39,822
100,488
25,736
25,736
56,671
171,426
43,797
25,736
66,428
107,083
31,240
Total ...................................................
.......................................................................................................................................
2,500,000
asabaliauskas on DSK3SPTVN1PROD with NOTICES
ORR provides 28 States and ten
Wilson-Fish agencies with Refugee
School Impact funding to undertake a
comprehensive statewide approach
supporting local school systems that are
impacted by significant numbers of
newly arrived refugee children. As
currently awarded, the FY14–16
Refugee School Impact funding period
concludes on August 14, 2016.
Beginning in FFY17, ORR will award
Refugee School Impact funding as a
formula set-aside within the Refugee
Social Services funding awarded to all
States and Wilson-Fish programs
coordinating refugee resettlement. This
change in timing for Refugee School
Impact funding will create a gap in
Refugee School Impact program services
between August 15, 2016 and October 1,
2016. The low-cost extensions will
support refugee access to services
critical to refugee student success at the
beginning of the school year, when such
services are greatest and most urgent.
DATES: Low-cost extension supplement
grants will support activities from
August 15, 2016, through September 30,
2016.
FOR FURTHER INFORMATION CONTACT: Carl
Rubenstein, Director, Division of
Refugee Assistance, Office of Refugee
Resettlement, 330 C Street SW.,
Washington, DC 20201. Email:
carl.rubenstein@acf.hhs.gov.
Statutory Authority: This program is
authorized by Section 412(c)(1)(A)(iii) of the
Immigration and Nationality Act (INA), 8
U.S.C. 1522(c)(1)(A)(iii).
Christopher Beach,
Senior Grants Policy Specialist, Office of
Administration, Office of Financial Services,
Division of Grants Policy.
[FR Doc. 2016–25496 Filed 10–20–16; 8:45 am]
BILLING CODE 4184–01–P
VerDate Sep<11>2014
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Jkt 241001
Amount
Food and Drug Administration
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
[Docket No. FDA–2010–D–0319]
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry and Food and Drug
Administration Staff on Dear Health
Care Provider Letters: Improving
Communication of Important Safety
Information
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
(the PRA).
DATES: Fax written comments on the
collection of information by November
21, 2016.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0754. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
SUMMARY:
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Fmt 4703
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In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Guidance for Industry and Food and
Drug Administration Staff on Dear
Health Care Provider Letters:
Improving Communication of
Important Safety Information—OMB
Control Number 0910–0754—Extension
This final Guidance for Industry and
FDA staff entitled ‘‘Dear Health Care
Provider Letters: Improving
Communication of Important Safety
Information’’ offers specific guidance 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.
This guidance gives specific
instruction on what should and should
not be included in DHCP letters. To
date, 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
E:\FR\FM\21OCN1.SGM
21OCN1
72809
Federal Register / Vol. 81, No. 204 / Friday, October 21, 2016 / Notices
sometimes been sent for the wrong
reasons.
In addition to content and format
recommendations for each type of DHCP
letter, the guidance also includes advice
on consulting with FDA to develop a
DHCP letter, when to send a letter, what
type of letter to send, and conducting an
assessment of the letter’s impact.
Based on a review of FDA’s Document
Archiving, Reporting and Regulatory
Tracking System for 2012 to 2015, we
identified DHCP letters that were sent
and the identity of each sponsor sending
out a DHCP letter for each year. We
estimate that we will receive
approximately 25 DHCP Letters
annually from approximately 18
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 March 10,
2016 (81 FR 12734), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. No comments
were received.
FDA estimates the annual reporting
burden of this collection of information
as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of respondents
Number of responses per
respondent
Total annual
responses
Average burden per response (hours)
Total hours
Annual average ....................................................................
18
1.4
25
100
2,500
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 17, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–25481 Filed 10–20–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Request for Nominations for Voting
Members on a Public Advisory
Committee; Food Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on the Food Advisory Committee
(the Committee), Office of Regulations,
Policy, and Social Sciences, Center for
Food Safety and Applied Nutrition.
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
DATES: Nominations received on or
before December 20, 2016, will be given
first consideration for membership on
the Food Advisory Committee.
Nominations received after December
20, 2016, will be considered for
nomination to the committee as later
vacancies occur.
ADDRESSES: All nominations for
membership should be sent
electronically by logging into the FDA
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
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Jkt 241001
Advisory Committee Membership
Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002.
FOR FURTHER INFORMATION CONTACT:
Regarding all nomination questions for
membership, the primary contact is:
Karen Strambler, 5001 Campus Drive,
Rm. 1C–008, College Park, MD 20740,
email: karen.strambler@fda.hhs.gov,
240–402–2589, Fax: 301–436–2367.
Information about becoming a
member on an FDA advisory committee
can also be obtained by visiting FDA’s
Web site by using the following link:
https://www.fda.gov/
AdvisoryCommittees/default.htm.
SUPPLEMENTARY INFORMATION: FDA is
requesting nomination for voting
members on the Committee.
I. General Description of the Committee
Duties
The Committee reviews and evaluates
emerging food safety, nutrition, and
other food- or cosmetic-related health
issues that FDA considers of primary
importance for its food and cosmetics
programs. The Committee may be
charged with reviewing and evaluating
available data and making
recommendations on matters such as
those relating to: (1) Broad scientific and
technical food- or cosmetic-related
issues, (2) the safety of food ingredients
and new foods, (3) labeling of foods and
cosmetics, (4) nutrient needs and
nutritional adequacy, and (5) safe
exposure limits for food contaminants.
The Committee may also be asked to
provide advice and make
PO 00000
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Fmt 4703
Sfmt 4703
recommendations on ways of
communicating to the public the
potential risks associated with these
issues and on approaches that might be
considered for addressing the issues.
II. Criteria for Voting Members
The Committee consists of a core of
15 voting members including the Chair.
Members and the Chair are selected by
the Commissioner of Food and Drugs
(the Commissioner) designee from
among authorities knowledgeable in the
fields of physical sciences, biological
and life sciences, food science, risk
assessment, nutrition, food technology,
molecular biology, epidemiology and
other relevant scientific and technical
disciplines. Members will be invited to
serve for overlapping terms of up to 4
years. Almost all non-Federal members
of this Committee serve as Special
Government Employees. The core of
voting members may include two
technically qualified member(s),
selected by the Commissioner or
designee, who are identified with
consumer interests and are
recommended by either a consortium of
consumer-oriented organizations or
other interested persons. In addition to
the voting members, the Committee may
include two non-voting member(s) who
are identified with industry interests.
III. Nomination Procedures
Any interested person may nominate
one or more qualified individuals for
membership on the advisory committee.
Self-nominations are also accepted.
Nominations must include a current,
´
´
complete resume or curriculum vitae for
each nominee, including current
business address and/or home address,
telephone number, and email address if
available. Nominations must also
E:\FR\FM\21OCN1.SGM
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Agencies
[Federal Register Volume 81, Number 204 (Friday, October 21, 2016)]
[Notices]
[Pages 72808-72809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25481]
-----------------------------------------------------------------------
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; Guidance for Industry
and Food and Drug Administration Staff on Dear Health Care Provider
Letters: Improving Communication of Important Safety Information
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 (the PRA).
DATES: Fax written comments on the collection of information by
November 21, 2016.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0754.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 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.
Guidance for Industry and Food and Drug Administration Staff on Dear
Health Care Provider Letters: Improving Communication of Important
Safety Information--OMB Control Number 0910-0754--Extension
This final Guidance for Industry and FDA staff entitled ``Dear
Health Care Provider Letters: Improving Communication of Important
Safety Information'' offers specific guidance 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.
This guidance gives specific instruction on what should and should
not be included in DHCP letters. To date, 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
[[Page 72809]]
sometimes been sent for the wrong reasons.
In addition to content and format recommendations for each type of
DHCP letter, the guidance also includes advice on consulting with FDA
to develop a DHCP letter, when to send a letter, what type of letter to
send, and conducting an assessment of the letter's impact.
Based on a review of FDA's Document Archiving, Reporting and
Regulatory Tracking System for 2012 to 2015, we identified DHCP letters
that were sent and the identity of each sponsor sending out a DHCP
letter for each year. We estimate that we will receive approximately 25
DHCP Letters annually from approximately 18 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 March 10, 2016 (81 FR 12734), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. No comments were received.
FDA estimates the annual reporting burden of this collection of
information as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of responses per Total annual per response Total hours
respondents respondent responses (hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual average..................................................... 18 1.4 25 100 2,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 17, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25481 Filed 10-20-16; 8:45 am]
BILLING CODE 4164-01-P