[Federal Register Volume 79, Number 64 (Thursday, April 3, 2014)]
[Notices]
[Pages 18693-18694]
[FR Doc No: 2014-07457]

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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.

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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,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>

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]
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