Contains Nonbinding Recommendations 
 
Gifts to FDA: Evaluation and Acceptance: 
Guidance for the Public and FDA Staff  
 
Additional copies are available from: 
 
Office of Policy 
Office of Policy, Planning, Legislation, and Analysis 
Food and Drug Administration 
10903 New Hampshire Avenue 
Silver Spring, MD 20993 
 
http://www.fda.gov/RegulatoryInformation/Guidances/default.htm 
 
You may submit either electronic or written comments regarding this guidance at any time.  
Submit electronic comments to http://www.regulations.gov. Submit written comments to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket. 
  
For questions regarding this document contact Robert Berlin in the Office of Policy at 301-796-
8828.  Alternate contact: Office of Policy, 301-796-4830. 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Policy, Planning, Legislation, and Analysis (OPPLA) 
Office of Policy (OP) 
 
December 2016 
Procedural 
 
 
 
 
 
 
   
  1  Contains Nonbinding Recommendations 
 
CONTENTS 
 
I.  PURPOSE ............................................................................................................................ 3 
II.  FRAMEWORK .................................................................................................................... 3 
III.  DONORS .............................................................................................................................. 4 
IV.  GIFTS ................................................................................................................................... 4 
V.  BALANCING TEST ............................................................................................................ 6 
VI.  ADDITIONAL ..................................................................................................................... 7 
 
   
  2  Contains Nonbinding Recommendations 
 
Gifts to FDA: Evaluation and Acceptance: 
Guidance for the Public and FDA Staff 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic. 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. To discuss an alternative approach, contact the FDA staff 
responsible for this guidance as listed on the title page. 
 
I.  PURPOSE 
 
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.1 The Secretary has 
delegated this gift authority to the Commissioner of Food and Drugs.2 This guidance provides 
the process and principles the Food and Drug Administration (we, FDA, or Agency) will use in 
implementing this authority for gifts from all sources except the Reagan-Udall Foundation (RUF).3 
 
FDAs guidance documents, including this guidance, generally do not establish legally 
enforceable responsibilities. Instead, guidances describe the Agencys current thinking on a topic 
and should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited. The use of the word should in Agency guidances means that something is 
suggested or recommended, but not required. 
II.  FRAMEWORK 
 
The Agency will consider gifts from all sources except RUF on a case-by-case basis using this 
framework and the balancing test described later in this document. While any person4 may offer 
a gift, there are five reasons FDA should reject a gift without additional evaluation. FDA should 
not accept a gift if: 
 
                                                 
1 Section 231 of the Public Health Service Act (42 U.S.C.  238). Such gifts must be for the benefit of the Public 
Health Service (of which FDA is a part) or for carrying out any of its functions. 
2 FDA Staff Manual Guides, Volume II - Delegations of Authority. SMG 1410.10. Section 1, Paragraph 19. FDA. 
2016. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/StaffManualGuides/UCM273771.pdf 
3 Evaluation of gifts from RUF will reflect RUFs unique role in support of the agency and the statutory safeguards 
in 21 U.S.C.  379dd.  FDA is considering developing a guidance addressing gifts from RUF. 
4 Section 201(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.  321(e)) defines the term person to 
include individual, partnership, corporation, and association. 
  3  Contains Nonbinding Recommendations 
 
1.  The donor imposes conditions that are illegal, are contrary to public policy, are 
unreasonable to administer, are contrary to FDAs current policies and procedures, or are 
contrary to generally accepted public standards.5  
2.  The donor requires the Agency to provide the donor with some privilege, concession, or 
other real or apparent present or future benefit in return for the gift. 
3.  A debarred entity offers the gift.  
4.  A different authority or financial mechanism applies. If we decline resources covered by 
those other authorities or mechanisms, we should not then use our gift acceptance 
authority as an alternative means to accept the resources.  
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. 
III.  DONORS 
 
FDA should not accept a gift from regulated industry unless the gift addresses 
exceptional public health circumstances for which no other solution could be achieved in 
the time available. Such a case must be one in which the magnitude of the public health 
benefit overrides other concerns, and the gift must also otherwise meet the criteria in the 
balancing test we describe later in this document. The Commissioner alone holds the 
authority to identify such exceptional circumstances.6 
 
FDA should not consider a gift if the person offering the gift is debarred, a relatively uncommon 
designation that prohibits a person from doing business with FDA or other agencies in the 
Federal Government. This disqualification should last only as long as the entity is debarred. 
After that period of time, any gift they offer would be subject to the balancing test described in 
this guidance.  
IV.  GIFTS 
 
As used in this guidance, gifts means resources of monetary value given to FDA as an 
institution, including competitive grants awarded to FDA employees as part of their official 
duties, including: funds for either general or specific purposes, data, materials, items, 
information, or services. As used in this guidance, gifts does not include resources of monetary 
value to which a different authority or financial mechanism applies, such as resources the 
Agency collects or receives in the course of carrying out our regulatory responsibilities. Other 
examples of such resources are included below. 
 
Competitive grants from non-federal sources are a type of conditional gift, and this guidance 
applies to such offers. FDA should analyze competitive grants as gifts and assess them using the 
same balancing test. 
                                                 
5 Consistent with National Institutes of Health (NIH) standards. See: NIH Policy Manual 1135 - Gifts 
Administration. NIH. 2011. http://oma1.od.nih.gov/manualchapters/management/1135/1135.pdf 
6 The identification by the Commissioner of exceptional circumstances for the purpose of this policy does not 
constitute any declaration or designation of an emergency or crisis as described in statute. Identification of 
exceptional circumstances by the Commissioner does not conflict with or preempt any existing public health 
authority. 
  4  Contains Nonbinding Recommendations 
 
 
Gifts not disqualified or denied should be subject to further review under a balancing test to 
assess whether the benefits of the gift to FDAs public health mission outweigh the real and/or 
apparent risks and conflicts of interest. 
 
The following are examples not considered gifts within the scope of this document: 
 
1.  Gifts to individual employees, which are governed by various statutory and regulatory 
requirements, including the Standards of Ethical Conduct for Employees of the Executive 
Branch 7 (5 CFR  2635).  
2.  Resources provided under Cooperative Research and Development Agreements, co-
sponsorship agreements, Material Transfer and Data Transfer Agreement authorities, and 
existing fellowship authorities (e.g., Reagan-Udall Foundation). 
3.  Samples taken by FDA during inspections.8 
4.  Data or information submitted to FDA as part of: 
a.  an application for market authorization or clearance,  
b.  manufacturers submitting samples for lot release testing, 
c.  comments to the Agency on a regulatory policy or proposal through a public 
docket or otherwise, or 
d.  information sharing and general collaboration that is intended to assist the Agency 
in the development of regulations, policy, and procedures. 
5.  Personal services including volunteering. 
6.  Outside resources for travel that are covered by other statutes and guidelines.9, 10, 11 
7.  Real property, i.e., land and the improvements thereto, including buildings.12 Authority to 
accept gifts of real property is expressly not within the Agencys delegated authority.13 
 
Conditional and Unconditional Gifts 
 
Gifts are categorized as unconditional or conditional. A gift will be considered unconditional if it 
is made to FDA for the carrying out of any of its functions, without further specification as to its 
                                                 
7 Standards of Ethical Conduct for Employees of the Executive Branch. FDA. 2011. http://www.oge.gov/Laws-and-
Regulations/Employee-Standards-of-Conduct/Standards-of-Ethical-Conduct-for-Employees-of-the-Executive-
Branch-(PDF)/ 
8 The taking of samples during FDA inspections is contemplated by the Federal Food, Drug, and Cosmetic Act, see 
704(c) and (d). While FDA does offer to pay for samples, and the owners of the facilities being inspected can choose 
to request payment or not, FDA has never considered a decision not to request payment to be a gift to the Agency, 
and we see no reason to change that position.  
9 E.g., 5 USC  4111, 5 USC  5707, 5 USC  7342, 31 USC  1353, 42 USC  3506, 5 CFR Part 2635 Subpart E, 
41 CFR Chapter 304. 
10 E.g., FDA Staff Manual Guides, Volume III  General Administration, Financial Management, Travel, 
Acceptance of Payment for Travel Expenses from Non-federal Sources. FDA. 2008. 
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/StaffManualGuides/UCM256332.pdf 
11 E.g., HHS Travel Policy Manual. HHS. 2012. http://www.psc.gov/docs/default-
source/travel/2012_policy_manual.pdf?sfvrsn=4 
12 FDA Staff Manual Guides, Volume II - Delegations of Authority. SMG 1410.10. Section 1, Paragraph 19. FDA. 
2016. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/StaffManualGuides/UCM273771.pdf 
13 FDA Staff Manual Guides, Volume II - Delegations of Authority. SMG 1410.10. Section 1, Paragraph 19. FDA. 
2016. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/StaffManualGuides/UCM273771.pdf 
  5  Contains Nonbinding Recommendations 
 
purpose or manner of use. A gift will also be considered unconditional if it is limited to one or 
more of the general purposes of any part of FDA.   
 
A gift will be considered conditional if the donor restricts its purpose, or imposes conditions, to 
support a specific research study, project, or conference; to support activities of an FDA 
employee identified by organizational affiliation; to support specifically identified functions, 
such as observances, ceremonies, particular public information or health promotion campaigns, 
community outreach activities; or purchase of specific items or types of equipment, or other 
specific uses. This guidance applies to both conditional and unconditional gifts except regarding 
delegation of the authority to accept gifts.14  
V.  BALANCING TEST 
 
The benefits of the gift to FDAs mission and the public health should outweigh any real and/or 
apparent risks and conflicts of interest. A balancing test demands development of the factual 
context and circumstances and allows application of all relevant legal and prudential factors. We 
may request that potential donors disclose in writing relevant information such as a list of the 
donors business affiliations and subsidiaries, and any matters expected to require the Agencys 
attention. The following are the minimum factors to consider in applying this balancing test.  
 
1.  What is the nature and magnitude of the public health benefit expected from the gift? 
  Is the gift consistent with the public health mission and goals of FDA? 
  How significant is the public health need? 
  How closely does the gift target the need? In what ways is the gift expected to address 
the need? Is the relationship between the gift and the need obvious and direct? 
  Would an alternate approach to attaining the benefit be feasible and more 
appropriate?  Can the gift be accepted by another PHS agency without raising the 
same conflict of interest concerns while still achieving the same public health benefit? 
 
2.  What is the nature and magnitude of any real or apparent conflict of interest? 
  Would accepting the gift compromise or appear to compromise the independence, 
integrity, or impartiality of the Agency? Would accepting the gift diminish public 
trust by reflecting unfavorably upon the ability of the Agency to carry out its 
responsibilities in a fair and objective manner? 
  Can public perception of any conflict be adequately managed? 
  Does the timing of the gift raise any concerns? 
  Does the size of the gift raise any concerns? 
  Do the circumstances indicate that the gift is neither a result of coercion nor an 
attempt to influence decision making or obtain an advantage? 
 
3.  Donor characteristics to consider: 
  Is this donor regulated by the Agency? If so, a gift may not be accepted unless it is 
intended to address an exceptional public health circumstances for which no other 
solution could be achieved in the time available. 
                                                 
14 See Delegation of Authority in Section IV of this guidance. 
  6  Contains Nonbinding Recommendations 
 
  What is the effect of the outcome of the gift on the donor? What is the nature and 
magnitude of the benefit to the donor (if any)? Is the donor willing to waive or 
transfer rights or ownership of any associated intellectual property that is generated as 
a result of the gift?  
  Has the donor made contributions to the Agency on such a frequent basis as to create 
an appearance of impropriety? Might the accumulation of accepted gifts over a period 
of time result in diminishing the appearance of FDAs independence, integrity and 
impartiality? 
  Is the donor engaged in litigation with the U.S. Government, or has the donor been 
suspended or terminated for cause or default by the U.S. Government?  
  Is FDA aware of the donor presently or previously exhibiting poor or questionable 
contract or grant performance that may 1) lead to the initiation of an adverse action 
against the donor, 2) lead one to question the donors integrity, or 3) raise a concern 
regarding the Governments affiliation with that donor?  
  Is the donor an interested party in pre-award activities surrounding an acquisition, 
grant, cooperative agreement, or other type of obligating instrument? 
  Is the donor a company that has a corporate relationship with a debarred company 
(e.g., is a parent or subsidiary company)? Is the donor a member of any consortium to 
which a debarred company belongs? 
  Consider the full scope of the donors relationship to the Agency, Department, and 
sister agencies. 
  If multiple persons in addition to the Agency are offered a certain gift, would the 
identity of any other expected recipients of the gift on the same occasion reflect 
poorly on the Agency? 
 
4.  Characteristics of the FDA recipient Center/Office to consider: 
  Is the value of the gift a significant percentage of the budget of the office(s) that will 
use the gift? 
  Are there mechanisms for recusing employee(s) whose official duties or office 
benefits from the gift from matters directly affecting the donor (e.g., is an effective 
firewall or recusal possible) when a real or apparent conflict of interest exists? 
  Is the gift reasonable to administer in the current fiscal year and/or multi-years? 
  What is the source of funding?  
VI.  ADDITIONAL 
 
Solicitation 
 
The Agency should not solicit gifts unless there are exceptional public health circumstances for 
which no other solution could be achieved in the time available. In such cases, the solicitation 
can be made by the Commissioner or his/her delegate to achieve a specific, clearly defined 
outcome.  
 
The following circumstances are not considered solicitation for the purpose of this guidance: 
  Applications for competitive grants open to a wide range of applicants from organizations 
such as foundations, non-profit groups, academic organizations, et al. 
  7  Contains Nonbinding Recommendations 
 
  Discussions of an unsolicited gift are underway with a potential donor, so FDA can 
ensure 1) the terms of the gift meet all legal and ethical requirements, 2) the gift will 
promote public health and the FDA mission, and 3) the gift is practical for FDA to accept 
and use. 
 
Transparency 
 
Our use of this gift acceptance authority should be transparent to our stakeholders.  FDA will 
post basic information about each gift on the FDA Ethics Office external website.15 The website 
will show a list of gifts received with basic facts about the gift: a description of the gift, a dollar 
amount (if possible), duration (if any), the Center(s)/office(s) using the gift, information 
identifying the donor, a short statement of purpose that includes a description of the public health 
benefit, and the date that FDA received the gift.  
 
Non-endorsement 
 
The written agreement memorializing the gift should include a non-endorsement provision. The 
non-endorsement provision will state that the donor may not suggest or imply that the gift 
indicates any further partnership between FDA and the donor. It also will state that the donor 
may not suggest or imply any tacit or explicit endorsement by FDA of any activities or products 
of the donor as a result of the gift. 
 
Opt-out provision 
 
FDA retains the ability to reevaluate any gift. FDA retains the ability to halt use of the gift at any 
time after acceptance for any reason.  
 
Delegation of Authority 
 
The authority to accept a gift valued over $5,000 is vested solely in the Commissioner, but other 
officials may decline any gift of any value. A decision by a Center Director or Deputy 
Commissioner to reject a gift is final. The Commissioner may delegate only the authority to 
accept unconditional gifts valued at $5,000 or less.16  
 
 
                                                 
15 http://www.fda.gov/AboutFDA/WorkingatFDA/Ethics/ucm464313.htm 
16 FDA Staff Manual Guides, Volume II - Delegations of Authority. SMG 1410.10. Section 1, Paragraph 19. FDA. 
2016. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/StaffManualGuides/UCM273771.pdf 
 
  8