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
<![CDATA[
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]
-----------------------------------------------------------------------
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
