81 FR 91180 - Gifts to the Food and Drug Administration: Evaluation and Acceptance; Guidance for the Public and Food and Drug Administration; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 242 (December 16, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 242 (December 16, 2016)
| Page Range | 91180-91181 | |
| FR Document | 2016-30312 |
[Federal Register Volume 81, Number 242 (Friday, December 16, 2016)] [Notices] [Pages 91180-91181] From the Federal Register Online [www.thefederalregister.org] [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: http://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, [email protected]. 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 http://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
![91180 Federal Register / Vol. 81, No. 242 / Friday, December 16, 2016 / Notices
European Medicines Agency; language such as ‘‘shall,’’ ‘‘must,’’ United States. The Secretary has
International Federation for Animal ‘‘require,’’ or ‘‘requirement,’’ unless delegated this gift authority to the
Health—Europe; FDA; the U.S. FDA is using these words to describe a Commissioner of Food and Drugs. This
Department of Agriculture; the U.S. statutory or regulatory requirement. guidance provides the process and
Animal Health Institute; the Japanese This guidance represents the current principles we will use in implementing
Ministry of Agriculture, Forestry, and thinking of FDA on ‘‘Bioequivalence: this authority.
Fisheries; and the Japanese Veterinary Blood Level Bioequivalence Study.’’ It DATES: Submit either electronic or
Products Association. does not establish any rights for any written comments on Agency guidances
Six observers are eligible to person and is not binding on FDA or the at any time.
participate in the VICH Steering public. You can use an alternative
ADDRESSES: You may submit comments
Committee: One representative from the approach if it satisfies the requirements
government of Australia/New Zealand, as follows:
of the applicable statutes and
one representative from the industry in regulations. Electronic Submissions
Australia/New Zealand, one
IV. Paperwork Reduction Act of 1995 Submit electronic comments in the
representative from the government of
This guidance refers to previously following way:
Canada, one representative from the
approved collections of information • Federal eRulemaking Portal:
industry of Canada, one representative
found in FDA regulations. These https://www.regulations.gov. Follow the
from the government of South Africa,
and one representative from the collections of information are subject to instructions for submitting comments.
industry of South Africa. The VICH review by the Office of Management and Comments submitted electronically,
Secretariat, which coordinates the Budget (OMB) under the Paperwork including attachments, to https://
preparation of documentation, is Reduction Act of 1995 (44 U.S.C. 3501– www.regulations.gov will be posted to
provided by the International 3520). The collections of information in the docket unchanged. Because your
Federation for Animal Health (IFAH). 21 CFR part 514 have been approved comment will be made public, you are
under OMB control number 0910–0032. solely responsible for ensuring that your
II. Guidance on Bioequivalence: Blood comment does not include any
The collections of information in
Level Bioequivalence Study confidential information that you or a
section 512(n)(1) of the FD&C Act (21
In the Federal Register of September U.S.C. 360K) have been approved under third party may not wish to be posted,
24, 2014 (79 FR 57113), FDA published OMB control number 0910–0669. such as medical information, your or
the notice of availability for a draft anyone else’s Social Security number, or
guidance for industry entitled V. Electronic Access confidential business information, such
‘‘Bioequivalence: Blood Level Persons with access to the Internet as a manufacturing process. Please note
Bioequivalence Study’’ (VICH GL52) may obtain the guidance at either http:// that if you include your name, contact
giving interested persons until www.fda.gov/AnimalVeterinary/ information, or other information that
November 24, 2014, to comment on the GuidanceComplianceEnforcement/ identifies you in the body of your
draft guidance. FDA received one GuidanceforIndustry/default.htm or comments, that information will be
comment on the draft guidance, and that http://www.regulations.gov. posted on https://www.regulations.gov.
comment, as well as those received by • If you want to submit a comment
Dated: December 12, 2016.
other VICH member regulatory agencies, with confidential information that you
Leslie Kux,
was considered as the guidance was do not wish to be made available to the
Associate Commissioner for Policy. public, submit the comment as a
finalized. The guidance announced in
[FR Doc. 2016–30309 Filed 12–15–16; 8:45 am] written/paper submission and in the
this notice finalizes the draft guidance
dated September 2014. The final BILLING CODE 4164–01–P manner detailed (see ‘‘Written/Paper
guidance is a product of the Submissions’’ and ‘‘Instructions’’).
Bioequivalence Expert Working Group Written/Paper Submissions
DEPARTMENT OF HEALTH AND
of the VICH.
HUMAN SERVICES Submit written/paper submissions as
This VICH guidance document is
intended to harmonize the data follows:
Food and Drug Administration
recommendations associated with in • Mail/Hand delivery/Courier (for
vivo blood level bioequivalence (BE) for [Docket No. FDA–2015–D–4361] written/paper submissions): Division of
veterinary pharmaceutical products. To Dockets Management (HFA–305), Food
Gifts to the Food and Drug and Drug Administration, 5630 Fishers
meet this objective, the guidance
Administration: Evaluation and Lane, Rm. 1061, Rockville, MD 20852.
addresses the following topics: A
Acceptance; Guidance for the Public • For written/paper comments
harmonized definition of BE, factors/
and Food and Drug Administration; submitted to the Division of Dockets
variables that should be considered
Availability Management, FDA will post your
when developing scientifically sound
blood level BE study designs, and AGENCY: Food and Drug Administration, comment, as well as any attachments,
information that should be included in HHS. except for information submitted,
a blood level BE study report. ACTION: Notice of availability. marked and identified, as confidential,
if submitted as detailed in
III. Significance of Guidance SUMMARY: The Food and Drug ‘‘Instructions.’’
This guidance, developed under the Administration (FDA, we, or Agency) is Instructions: All submissions received
mstockstill on DSK3G9T082PROD with NOTICES
VICH process, is being issued consistent announcing the availability of a must include the Docket No. FDA–
with FDA’s good guidance practices guidance for industry entitled ‘‘Gifts to 2015–D–4361 for ‘‘Gifts to FDA:
regulation (21 CFR 10.115). For FDA: Evaluation and Acceptance.’’ The Evaluation and Acceptance: Guidance
example, the document has been Secretary of the Department of Health for the Public and FDA Staff;
designated ‘‘guidance’’ rather than and Human Services (HHS) has the Availability.’’ Received comments will
‘‘guideline.’’ In addition, guidance authority to accept conditional or be placed in the docket and, except for
documents must not include mandatory unconditional gifts on behalf of the those submitted as ‘‘Confidential
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![Federal Register / Vol. 81, No. 242 / Friday, December 16, 2016 / Notices 91181
Submissions,’’ publicly viewable at Analysis, Food and Drug the Agency and the statutory safeguards
https://www.regulations.gov or at the Administration, Bldg. 32, Rm. 4238, in 21 U.S.C. 379dd. In addition, the
Division of Dockets Management 10903 New Hampshire Ave., Silver discussion of restrictions on funds for
between 9 a.m. and 4 p.m., Monday Spring, MD, 20993, 301–796–8828, travel has been clarified to better reflect
through Friday. robert.berlin@fda.hhs.gov. Alternate the scope of statutes and policies
• Confidential Submissions—To contact: Office of Policy, 301–796–4830. governing the use of non-Agency funds
submit a comment with confidential SUPPLEMENTARY INFORMATION: for travel.
information that you do not wish to be This guidance is being issued
made publicly available, submit your I. Background consistent with FDA’s good guidance
comments only as a written/paper FDA is announcing the availability of practices regulation (21 CFR 10.115).
submission. You should submit two a guidance for the public and FDA staff The guidance represents the current
copies total. One copy will include the entitled ‘‘Gifts to FDA: Evaluation and thinking of FDA on this matter. It does
information you claim to be confidential Acceptance.’’ The Secretary of HHS has not establish any rights for any person
with a heading or cover note that states the authority to accept conditional or and is not binding on FDA or the public.
‘‘THIS DOCUMENT CONTAINS unconditional gifts on behalf of the You can use an alternative approach if
CONFIDENTIAL INFORMATION.’’ The United States. The Secretary has it satisfies the requirements of the
Agency will review this copy, including delegated this gift authority to the applicable statutes and regulations.
the claimed confidential information, in Commissioner of Food and Drugs. This
II. Electronic Access
its consideration of comments. The guidance provides the process and
second copy, which will have the principles we will use in implementing Persons with access to the Internet
claimed confidential information this authority. may obtain the guidance at either http://
redacted/blacked out, will be available FDA will consider gifts from all www.fda.gov/RegulatoryInformation/
for public viewing and posted on sources except the Reagan-Udall Guidances/default.htm or https://
https://www.regulations.gov. Submit Foundation (RUF) on a case-by-case www.regulations.gov.
both copies to the Division of Dockets basis using a balancing test, described in Dated: December 13, 2016.
Management. If you do not wish your the guidance. While any person may Leslie Kux,
name and contact information to be offer a gift, there are five reasons we Associate Commissioner for Policy.
made publicly available, you can should reject a gift without additional
[FR Doc. 2016–30312 Filed 12–15–16; 8:45 am]
provide this information on the cover evaluation. We should not accept a gift
BILLING CODE 4164–01–P
sheet and not in the body of your if: (1) The donor imposes conditions
comments and you must identify this that are illegal, are contrary to public
information as ‘‘confidential.’’ Any policy, are unreasonable to administer, DEPARTMENT OF HEALTH AND
information marked as ‘‘confidential’’ are contrary to FDA’s current policies HUMAN SERVICES
will not be disclosed except in and procedures, or are contrary to
accordance with 21 CFR 10.20 and other generally accepted public standards; (2) Food and Drug Administration
applicable disclosure law. For more the donor requires us to provide the
donor with some privilege, concession, [Docket No. FDA–2016–N–3995]
information about FDA’s posting of
comments to public dockets, see 80 FR or other present or future benefit in Agency Information Collection
56469, September 18, 2015, or access return for the gift; (3) a debarred entity Activities; Proposed Collection;
the information at: http://www.fda.gov/ offers the gift; (4) a different authority or Comment Request; Medical Devices;
financial mechanism applies; or (5) the
regulatoryinformation/dockets/ Pediatric Uses of Devices;
total costs associated with acceptance
default.htm. Requirement for Submission of
Docket: For access to the docket to are expected to exceed the cost of
Information on Pediatric
read background documents or the purchasing a similar item and the cost
Subpopulations That Suffer From a
electronic and written/paper comments of normal care and maintenance.
In the Federal Register of June 29, Disease or Condition That a Device Is
received, go to https:// Intended To Treat, Diagnose, or Cure
2016 (81 FR 42365), FDA announced the
www.regulations.gov and insert the
availability of a draft guidance entitled AGENCY: Food and Drug Administration,
docket number, found in brackets in the ‘‘Gifts to FDA: Evaluation and
heading of this document, into the HHS.
Acceptance: Evaluation and ACTION: Notice.
‘‘Search’’ box and follow the prompts Acceptance.’’ FDA received one
and/or go to the Division of Dockets comment expressing concern regarding SUMMARY: The Food and Drug
Management, 5630 Fishers Lane, Rm. the policy described in the guidance. It Administration (FDA or Agency) is
1061, Rockville, MD 20852. appears the commenter may have announcing an opportunity for public
Submit written requests for single misunderstood the policy and comment on the proposed collection of
copies of this guidance to the Office of incorrectly believed that gifts would not certain information by the Agency.
Policy, Office of Policy, Planning, be limited, would be unreported, and Under the Paperwork Reduction Act of
Legislation, and Analysis, Food and would be provided to Federal 1995 (the PRA), Federal Agencies are
Drug Administration, Bldg. 32, Rm. employees themselves. As explained in required to publish notice in the
4238, 10903 New Hampshire Ave., the guidance, that is not the case. Federal Register concerning each
Silver Spring, MD, 20993. Send one self- Rather, the recipients of any gifts would proposed collection of information,
addressed adhesive label to assist that be the Agency, gifts are extensively including each proposed extension of an
mstockstill on DSK3G9T082PROD with NOTICES
office in processing your requests. See reviewed to ensure receipt would be existing collection of information, and
the SUPPLEMENTARY INFORMATION section appropriate, and the Agency intends to to allow 60 days for public comment in
for electronic access to the guidance publish a summary of received gifts. response to the notice. This notice
document. The Agency has made only minor solicits comments on information
FOR FURTHER INFORMATION CONTACT: changes to the guidance to clarify that collection associated with the
Robert Berlin, Office of Policy, Office of the evaluation of gifts from RUF will requirement for submission of
Policy, Planning, Legislation, and reflect RUF’s unique role in support of information on pediatric subpopulations
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Document Created: 2018-02-14 09:07:10
Document Modified: 2018-02-14 09:07:10
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| 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, [email protected] Alternate contact: Office of Policy, 301-796-4830. | |
| FR Citation | 81 FR 91180 |
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