
[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]


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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.

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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, 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 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


