Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Dear Health Care Provider Letters: Improving Communication of Important Safety Information, 64541-64542 [2019-25333]
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Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices
Based on Agency data, we have
received no more than 50 submissions
since establishing the collection in
2017.
Dated: November 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25364 Filed 11–21–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–4844]
‘‘Ruby Chocolate’’ Deviating From
Identity Standard; Temporary Permit
for Market Testing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a temporary permit has
been issued to Barry Callebaut U.S.A.
LLC (the applicant) to market test a
product identified as ‘‘ruby chocolate’’
that deviates from the U.S. standards of
identity for chocolate products. The
temporary permit will allow the
applicant to evaluate commercial
viability of the product and to collect
data on consumer acceptance of the
product.
SUMMARY:
This permit is effective for 15
months, beginning on the date the
applicant introduces or causes
introduction of the test product into
interstate commerce, but not later than
February 20, 2020.
FOR FURTHER INFORMATION CONTACT:
Marjan Morravej, Center for Food Safety
and Applied Nutrition (HFS–820), Food
and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240–402–
2371.
SUPPLEMENTARY INFORMATION: We are
giving notice that we have issued a
temporary permit to Barry Callebaut
U.S.A. LLC. We are issuing the
temporary permit in accordance with 21
CFR 130.17, which addresses temporary
permits for interstate shipment of
experimental packs of food varying from
the requirements of definitions and
standards of identity issued under
section 401 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 341).
The permit covers the interstate
market testing of the product identified
as ‘‘ruby chocolate.’’ The test product
deviates from the U.S. standards of
identity for chocolates (21 CFR 163.111,
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DATES:
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163.123, 163.124, 163.130, 163.135,
163.140, and 163.145).
For the purpose of this permit, ‘‘ruby
chocolate’’ is the solid or semiplastic
food prepared by mixing and grinding
cacao fat with one or more of the cacao
ingredients (namely, chocolate liquor,
breakfast cocoa, cocoa, and lowfat
cocoa), citric acid, one or more of
optional dairy ingredients, and one or
more optional nutritive carbohydrate
sweeteners. ‘‘Ruby chocolate’’ contains
not less than 1.5 percent nonfat cacao
solids, not less than 20 percent by
weight of cacao fat, not less than 2.5
percent by weight of milk fat, not less
than 12 percent by weight of total milk
solids, not more than 1.5 percent of
emulsifying agents, and not more than
5 percent of whey or whey products. It
may also contain other ingredients such
as antioxidants approved for food use,
spices, natural and artificial flavorings,
and other seasonings. However, these
other ingredients cannot imitate the
flavor of chocolate, milk or butter, berry
or another fruit. Additionally, ‘‘ruby
chocolate’’ contains no added coloring.
The test product ‘‘ruby chocolate’’
contains the principal ingredients used
in most of the current standards for
cacao products under 21 CFR part 163;
however, it deviates from the current
standards of identity for chocolate
products in terms of its final
composition, taste, and color.
The purpose of the temporary permit
is to allow the applicant to market test
the product throughout the United
States. The permit will allow the
applicant to evaluate commercial
viability of the product and to collect
data on consumer acceptance of the
product.
The permit provides for the temporary
marketing of approximately 60 million
pounds (27,215,540 kilograms) of the
test product. The test product will be
manufactured at the Barry Callebaut
facilities located at Aalstersestraat 122,
9280 Lebbeke, Belgium; 400 Industrial
Park Rd., St. Albans, VT 05478; and
1175 Commerce Blvd., American
Canyon, CA 94503.
Barry Callebaut U.S.A. LLC will
distribute the test product to various
manufacturers throughout the United
States for further manufacturing and
market testing. Each ingredient used in
the food must be declared on the label
as required by 21 CFR part 101. The
permit is effective for 15 months,
beginning on the date the applicant
introduces or causes the introduction of
the test product into interstate
commerce, but not later than February
20, 2020.
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64541
Dated: November 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25325 Filed 11–21–19; 8:45 am]
BILLING CODE 4164–01–P
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 Health Care
Provider Letters: Improving
Communication of Important Safety
Information
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the 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.
SUMMARY:
Fax written comments on the
collection of information by December
23, 2019.
DATES:
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.
ADDRESSES:
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:
E:\FR\FM\22NON1.SGM
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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]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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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
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16:57 Nov 21, 2019
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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]
BILLING CODE 4140–01–P
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.
E:\FR\FM\22NON1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Pages 64541-64542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25333]
-----------------------------------------------------------------------
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 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, the 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: Fax written comments on the collection of information by
December 23, 2019.
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 [email protected]. 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: 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.
[[Page 64542]]
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 60-day 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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]
BILLING CODE 4164-01-P
