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, 18693-18694 [2014-07457]

Download as PDF pmangrum on DSK3VPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 64 / Thursday, April 3, 2014 / Notices • Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study. Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential nonresponse bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results. As a general matter, information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. Current Actions: Extension of approval for a collection of information. Type of Review: Extension. Affected Public: Individuals and households, businesses and organizations. Estimated Number of Respondents: 9,000,000 over 3 years. Below we provide projected average estimates for the next three years: Average Expected Annual Number of Activities: 15. Average Number of Respondents per Activity: 200,000. Annual Responses: 3,000,000. Frequency of Response: Once per request. Average Minutes per Response: 10. Burden hours: 500,000 hours annually. Request for Comments: Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. Comments are invited on: (a) Whether the collection of information is necessary VerDate Mar<15>2010 15:17 Apr 02, 2014 Jkt 232001 for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. All written comments will be available for public inspection Regulations.gov. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number. Darius Taylor, Deputy, Information Collection Clearance Officer. [FR Doc. 2014–07394 Filed 4–2–14; 8:45 am] BILLING CODE 4150–05–P PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 18693 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. 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. SUMMARY: 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 https://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: daniel.sigelman@fda.hhs.gov. DATES: E:\FR\FM\03APN1.SGM 03APN1 18694 Federal Register / Vol. 79, No. 64 / Thursday, April 3, 2014 / Notices SUPPLEMENTARY INFORMATION: DEPARTMENT OF THE INTERIOR I. Background Bureau of Land Management 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. [14XLLAZ910000.L12100000.XP0000LXSS 150A00006100.241A] II. Comments Interested persons may submit either electronic comments regarding this document to https://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 https:// www.regulations.gov. pmangrum on DSK3VPTVN1PROD with NOTICES III. Electronic Access Persons with access to the Internet may obtain the guidance at either https://www.fda.gov/ RegulatoryInformation/Guidances/ default.htm or https:// 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 VerDate Mar<15>2010 15:17 Apr 02, 2014 Jkt 232001 State of Arizona Resource Advisory Council Meetings Bureau of Land Management, Interior. ACTION: Notice of Public Meetings. AGENCY: In accordance with the Federal Land Policy and Management Act of 1976 and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management (BLM), Arizona Resource Advisory Council (RAC) will meet in Phoenix, Arizona, as indicated below. DATES: The RAC Working Groups will meet on May 7 from 8:30 a.m. to 4:30 p.m., and the Business meeting will take place May 8 from 8 a.m. to 4 p.m. ADDRESSES: The meetings will be held at the BLM National Training Center located at 9828 North 31st Avenue, Phoenix, Arizona 85051. FOR FURTHER INFORMATION CONTACT: Dorothea Boothe, Arizona RAC Coordinator at the Bureau of Land Management, Arizona State Office, One North Central Avenue, Suite 800, Phoenix, Arizona 85004–4427, 602– 417–9504. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1–800–877–8339 to contact the above individual during normal business hours. The FIRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours. SUPPLEMENTARY INFORMATION: The 15member Council advises the Secretary of the Interior, through the BLM, on a variety of planning and management issues associated with public land management in Arizona. Planned agenda items include: a welcome and introduction of Council members; BLM State Director’s update on BLM programs and issues; recommendations from the RAC Colorado River District Grazing Subcommittee; discussion and feedback on the Department of the Interior Themes and Landscape-Level Opportunities for the BLM; update on the Sonoran Landscape Project; update on the Rapid Ecoregional Assessments; reports by the RAC Working Groups; RAC questions on BLM District Manager Reports; and other items of interest to the RAC. Recommendations from the RAC Colorado River District Grazing SUMMARY: PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 Subcommittee will be presented to the RAC on the day of the business meeting for discussion and a vote. Members of the public are welcome to attend the Working Group and Business meetings. A public comment period is scheduled on the day of the Business meeting from 11:30 a.m. to 12 p.m. for any interested members of the public who wish to address the Council on BLM programs and business. Depending on the number of persons wishing to speak and time available, the time for individual comments may be limited. Written comments may also be submitted during the meeting for the RAC’s consideration. Final meeting agendas will be available two weeks prior to the meetings and posted on the BLM Web site at: https:// www.blm.gov/az/st/en/res/rac.html. Individuals who need special assistance, such as sign language interpretation or other reasonable accommodations, should contact the RAC Coordinator listed above no later than two weeks before the start of the meeting. Under the Federal Lands Recreation Enhancement Act, the RAC has been designated as the Recreation RAC (RRAC) and has the authority to review all BLM and Forest Service recreation fee proposals in Arizona. The RRAC will not review recreation fee program proposals at this meeting. Raymond Suazo, Arizona State Director. [FR Doc. 2014–07441 Filed 4–2–14; 8:45 am] BILLING CODE 4310–32–P DEPARTMENT OF THE INTERIOR National Park Service [NPS–PWR–PWRO–14919; PPPWPWROP0/ PX.P0118032i.00.1] Notice of Termination of Environmental Impact Statement for General Management Plan, Devils Postpile National Monument, Mono and Madera Counties, California National Park Service, Interior. Notice of Termination of Environmental Impact Statement. AGENCY: ACTION: The National Park Service is terminating the preparation of an Environmental Impact Statement (EIS) for the General Management Plan, Devils Postpile National Monument, Mammoth Lakes, California. A Notice of Intent to prepare the EIS for the General Management Plan (GMP) was published in the Federal Register on June 15, 2009. The National Park Service has since determined that an Environmental SUMMARY: E:\FR\FM\03APN1.SGM 03APN1

Agencies

[Federal Register Volume 79, Number 64 (Thursday, April 3, 2014)]
[Notices]
[Pages 18693-18694]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[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.

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

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 https://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:
daniel.sigelman@fda.hhs.gov.

[[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 https://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 https://www.regulations.gov.

III. Electronic Access

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

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