[Federal Register Volume 79, Number 64 (Thursday, April 3, 2014)]
[Notices]
[Pages 18693-18694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07457]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0261]

Food and Drug Administration


The Meaning of ``Spouse'' and ``Family'' in the Food and Drug 
Administration's Regulations After the Supreme Court's Ruling in United 
States v. Windsor--Questions and Answers: Guidance for Industry, 
Consumers, and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a guidance entitled ``The Meaning of `Spouse' and 
`Family' in FDA's Regulations after the Supreme Court's Ruling in 
United States v. Windsor--Questions and Answers: Guidance for Industry, 
Consumers, and FDA Staff.'' This guidance informs the public of FDA's 
interpretation of the effects of the Supreme Court's decision in United 
States v. Windsor on several of its regulations. This guidance has an 
immediate implementation date because FDA has determined that prior 
public participation is not feasible or appropriate.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Policy, Office of the Commissioner, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-4830. 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.
    Submit electronic comments on the guidance 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.

FOR FURTHER INFORMATION CONTACT: Daniel W. Sigelman, Office of the 
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 32, rm. 4254, Silver Spring, MD 20993, 301-796-4706, email: 
[email protected].

[[Page 18694]]


SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled, ``The 
Meaning of `Spouse' and `Family' in FDA's Regulations after the Supreme 
Court's Ruling in United States v. Windsor--Questions and Answers, 
Guidance for Industry, Consumers, and FDA Staff'' dated March 2014.
    On June 26, 2013, in United States v. Windsor, 133 S.Ct. 2675, the 
U.S. Supreme Court struck down as unconstitutional section 3 of the 
Defense of Marriage Act (Pub. L. 104-199). In the guidance we set forth 
how we will interpret the terms ``spouse'' and ``family'' in our 
regulations in accordance with this decision.
    Because this guidance provides FDA's interpretation of these terms 
in light of a ruling of the Supreme Court, this guidance is being 
implemented without prior public comment because the Agency has 
determined that prior public participation is not feasible or 
appropriate (21 CFR 10.115(g)(2)). Although this guidance document is 
immediately in effect, it remains subject to comment in accordance with 
the Agency's Good Guidance Practices regulation.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm 
or http://www.regulations.gov.

    Dated: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07457 Filed 4-2-14; 8:45 am]
BILLING CODE 4160-01-P