81 FR 42365 - Gifts to the Food and Drug Administration: Evaluation and Acceptance: Draft Guidance for the Public and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 125 (June 29, 2016)

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for the public and FDA staff entitled ``Gifts to FDA: Evaluation and Acceptance.''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.

[Federal Register Volume 81, Number 125 (Wednesday, June 29, 2016)]
[Notices]
[Pages 42365-42366]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-15385]


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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Acceptance: Draft Guidance for the Public and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for the public and FDA staff entitled 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: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that we consider your comment on this draft 
guidance before we begin work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
September 12, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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

[[Page 42366]]

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 http://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: Draft 
Guidance for the Public and FDA Staff; Availability''. Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://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 http://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.
    Submit written requests for single copies of the draft guidance to 
the Office of Policy, Office of the Commissioner, Food and Drug 
Administration, Bldg. 32, Rm. 4235, 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 draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Aaron Zimmerman, Office of Policy, 
Office of the Commissioner, Food and Drug Administration, Bldg. 32, Rm. 
4235, 10903 New Hampshire Ave., Silver Spring, MD, 20993. 301-796-0339, 
[email protected]. Alternate contact: Office of Policy, 301-
796-4830.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft 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 on a case-by-case basis 
using a balancing test, described in the draft 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.
    This draft guidance is being issued consistent with our good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent our current thinking 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 document at 
either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm 
or http://www.regulations.gov.

    Dated: June 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-15385 Filed 6-28-16; 8:45 am]
 BILLING CODE 4164-01-P