Gifts to the Food and Drug Administration: Evaluation and Acceptance; Guidance for the Public and Food and Drug Administration; Availability, 91180-91181 [2016-30312]
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91180
Federal Register / Vol. 81, No. 242 / Friday, December 16, 2016 / Notices
European Medicines Agency;
International Federation for Animal
Health—Europe; FDA; the U.S.
Department of Agriculture; the U.S.
Animal Health Institute; the Japanese
Ministry of Agriculture, Forestry, and
Fisheries; and the Japanese Veterinary
Products Association.
Six observers are eligible to
participate in the VICH Steering
Committee: One representative from the
government of Australia/New Zealand,
one representative from the industry in
Australia/New Zealand, one
representative from the government of
Canada, one representative from the
industry of Canada, one representative
from the government of South Africa,
and one representative from the
industry of South Africa. The VICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation for Animal Health (IFAH).
mstockstill on DSK3G9T082PROD with NOTICES
II. Guidance on Bioequivalence: Blood
Level Bioequivalence Study
In the Federal Register of September
24, 2014 (79 FR 57113), FDA published
the notice of availability for a draft
guidance for industry entitled
‘‘Bioequivalence: Blood Level
Bioequivalence Study’’ (VICH GL52)
giving interested persons until
November 24, 2014, to comment on the
draft guidance. FDA received one
comment on the draft guidance, and that
comment, as well as those received by
other VICH member regulatory agencies,
was considered as the guidance was
finalized. The guidance announced in
this notice finalizes the draft guidance
dated September 2014. The final
guidance is a product of the
Bioequivalence Expert Working Group
of the VICH.
This VICH guidance document is
intended to harmonize the data
recommendations associated with in
vivo blood level bioequivalence (BE) for
veterinary pharmaceutical products. To
meet this objective, the guidance
addresses the following topics: A
harmonized definition of BE, factors/
variables that should be considered
when developing scientifically sound
blood level BE study designs, and
information that should be included in
a blood level BE study report.
III. Significance of Guidance
This guidance, developed under the
VICH process, is being issued consistent
with FDA’s good guidance practices
regulation (21 CFR 10.115). For
example, the document has been
designated ‘‘guidance’’ rather than
‘‘guideline.’’ In addition, guidance
documents must not include mandatory
VerDate Sep<11>2014
18:42 Dec 15, 2016
Jkt 241001
language such as ‘‘shall,’’ ‘‘must,’’
‘‘require,’’ or ‘‘requirement,’’ unless
FDA is using these words to describe a
statutory or regulatory requirement.
This guidance represents the current
thinking of FDA on ‘‘Bioequivalence:
Blood Level Bioequivalence Study.’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
United States. The Secretary has
delegated this gift authority to the
Commissioner of Food and Drugs. This
guidance provides the process and
principles we will use in implementing
this authority.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
as follows:
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 514 have been approved
under OMB control number 0910–0032.
The collections of information in
section 512(n)(1) of the FD&C Act (21
U.S.C. 360K) have been approved under
OMB control number 0910–0669.
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
V. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: December 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–30309 Filed 12–15–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–4361]
Gifts to the Food and Drug
Administration: Evaluation and
Acceptance; Guidance for the Public
and Food and Drug Administration;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, we, or Agency) is
announcing the availability of a
guidance for industry entitled ‘‘Gifts to
FDA: Evaluation and Acceptance.’’ The
Secretary of the Department of Health
and Human Services (HHS) has the
authority to accept conditional or
unconditional gifts on behalf of the
SUMMARY:
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Frm 00066
Fmt 4703
Sfmt 4703
Electronic Submissions
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2015–D–4361 for ‘‘Gifts to FDA:
Evaluation and Acceptance: Guidance
for the Public and FDA Staff;
Availability.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
E:\FR\FM\16DEN1.SGM
16DEN1
mstockstill on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 81, No. 242 / Friday, December 16, 2016 / Notices
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of this guidance to the Office of
Policy, Office of Policy, Planning,
Legislation, and Analysis, Food and
Drug Administration, Bldg. 32, Rm.
4238, 10903 New Hampshire Ave.,
Silver Spring, MD, 20993. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Robert Berlin, Office of Policy, Office of
Policy, Planning, Legislation, and
VerDate Sep<11>2014
18:42 Dec 15, 2016
Jkt 241001
Analysis, Food and Drug
Administration, Bldg. 32, Rm. 4238,
10903 New Hampshire Ave., Silver
Spring, MD, 20993, 301–796–8828,
robert.berlin@fda.hhs.gov. Alternate
contact: Office of Policy, 301–796–4830.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for the public and FDA staff
entitled ‘‘Gifts to FDA: Evaluation and
Acceptance.’’ The Secretary of HHS has
the authority to accept conditional or
unconditional gifts on behalf of the
United States. The Secretary has
delegated this gift authority to the
Commissioner of Food and Drugs. This
guidance provides the process and
principles we will use in implementing
this authority.
FDA will consider gifts from all
sources except the Reagan-Udall
Foundation (RUF) on a case-by-case
basis using a balancing test, described in
the guidance. While any person may
offer a gift, there are five reasons we
should reject a gift without additional
evaluation. We should not accept a gift
if: (1) The donor imposes conditions
that are illegal, are contrary to public
policy, are unreasonable to administer,
are contrary to FDA’s current policies
and procedures, or are contrary to
generally accepted public standards; (2)
the donor requires us to provide the
donor with some privilege, concession,
or other present or future benefit in
return for the gift; (3) a debarred entity
offers the gift; (4) a different authority or
financial mechanism applies; or (5) the
total costs associated with acceptance
are expected to exceed the cost of
purchasing a similar item and the cost
of normal care and maintenance.
In the Federal Register of June 29,
2016 (81 FR 42365), FDA announced the
availability of a draft guidance entitled
‘‘Gifts to FDA: Evaluation and
Acceptance: Evaluation and
Acceptance.’’ FDA received one
comment expressing concern regarding
the policy described in the guidance. It
appears the commenter may have
misunderstood the policy and
incorrectly believed that gifts would not
be limited, would be unreported, and
would be provided to Federal
employees themselves. As explained in
the guidance, that is not the case.
Rather, the recipients of any gifts would
be the Agency, gifts are extensively
reviewed to ensure receipt would be
appropriate, and the Agency intends to
publish a summary of received gifts.
The Agency has made only minor
changes to the guidance to clarify that
the evaluation of gifts from RUF will
reflect RUF’s unique role in support of
PO 00000
Frm 00067
Fmt 4703
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91181
the Agency and the statutory safeguards
in 21 U.S.C. 379dd. In addition, the
discussion of restrictions on funds for
travel has been clarified to better reflect
the scope of statutes and policies
governing the use of non-Agency funds
for travel.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on this matter. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/RegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: December 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–30312 Filed 12–15–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–3995]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices;
Pediatric Uses of Devices;
Requirement for Submission of
Information on Pediatric
Subpopulations That Suffer From a
Disease or Condition That a Device Is
Intended To Treat, Diagnose, or Cure
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (the PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on information
collection associated with the
requirement for submission of
information on pediatric subpopulations
SUMMARY:
E:\FR\FM\16DEN1.SGM
16DEN1
Agencies
[Federal Register Volume 81, Number 242 (Friday, December 16, 2016)]
[Notices]
[Pages 91180-91181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30312]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-4361]
Gifts to the Food and Drug Administration: Evaluation and
Acceptance; Guidance for the Public and Food and Drug Administration;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
announcing the availability of a guidance for industry entitled ``Gifts
to FDA: Evaluation and Acceptance.'' The Secretary of the Department of
Health and Human Services (HHS) has the authority to accept conditional
or unconditional gifts on behalf of the United States. The Secretary
has delegated this gift authority to the Commissioner of Food and
Drugs. This guidance provides the process and principles we will use in
implementing this authority.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2015-D-4361 for ``Gifts to FDA: Evaluation and Acceptance: Guidance
for the Public and FDA Staff; Availability.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
[[Page 91181]]
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of this guidance to the
Office of Policy, Office of Policy, Planning, Legislation, and
Analysis, Food and Drug Administration, Bldg. 32, Rm. 4238, 10903 New
Hampshire Ave., Silver Spring, MD, 20993. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
FOR FURTHER INFORMATION CONTACT: Robert Berlin, Office of Policy,
Office of Policy, Planning, Legislation, and Analysis, Food and Drug
Administration, Bldg. 32, Rm. 4238, 10903 New Hampshire Ave., Silver
Spring, MD, 20993, 301-796-8828, robert.berlin@fda.hhs.gov. Alternate
contact: Office of Policy, 301-796-4830.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for the public and
FDA staff entitled ``Gifts to FDA: Evaluation and Acceptance.'' The
Secretary of HHS has the authority to accept conditional or
unconditional gifts on behalf of the United States. The Secretary has
delegated this gift authority to the Commissioner of Food and Drugs.
This guidance provides the process and principles we will use in
implementing this authority.
FDA will consider gifts from all sources except the Reagan-Udall
Foundation (RUF) on a case-by-case basis using a balancing test,
described in the guidance. While any person may offer a gift, there are
five reasons we should reject a gift without additional evaluation. We
should not accept a gift if: (1) The donor imposes conditions that are
illegal, are contrary to public policy, are unreasonable to administer,
are contrary to FDA's current policies and procedures, or are contrary
to generally accepted public standards; (2) the donor requires us to
provide the donor with some privilege, concession, or other present or
future benefit in return for the gift; (3) a debarred entity offers the
gift; (4) a different authority or financial mechanism applies; or (5)
the total costs associated with acceptance are expected to exceed the
cost of purchasing a similar item and the cost of normal care and
maintenance.
In the Federal Register of June 29, 2016 (81 FR 42365), FDA
announced the availability of a draft guidance entitled ``Gifts to FDA:
Evaluation and Acceptance: Evaluation and Acceptance.'' FDA received
one comment expressing concern regarding the policy described in the
guidance. It appears the commenter may have misunderstood the policy
and incorrectly believed that gifts would not be limited, would be
unreported, and would be provided to Federal employees themselves. As
explained in the guidance, that is not the case. Rather, the recipients
of any gifts would be the Agency, gifts are extensively reviewed to
ensure receipt would be appropriate, and the Agency intends to publish
a summary of received gifts. The Agency has made only minor changes to
the guidance to clarify that the evaluation of gifts from RUF will
reflect RUF's unique role in support of the Agency and the statutory
safeguards in 21 U.S.C. 379dd. In addition, the discussion of
restrictions on funds for travel has been clarified to better reflect
the scope of statutes and policies governing the use of non-Agency
funds for travel.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on this matter. It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.
II. Electronic Access
Persons with access to the Internet may obtain the guidance at
either https://www.fda.gov/RegulatoryInformation/Guidances/default.htm
or https://www.regulations.gov.
Dated: December 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30312 Filed 12-15-16; 8:45 am]
BILLING CODE 4164-01-P