80 FR 17048 - Proposed Information Collection Activity; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 80, Issue 61 (March 31, 2015)

Page Range		17048-17049
FR Document		2015-07316

Federal Register, Volume 80 Issue 61 (Tuesday, March 31, 2015)

[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Pages 17048-17049]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07316]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Proposed Information Collection Activity; Comment Request

    Title: Same-sex relationships: Updates to Healthy Marriage and 
Relationship Education.
    OMB No.: New Collection
    Description: The Administration for Children and Families (ACF) 
will examine how healthy marriage programs currently approach, and 
could approach, serving sexual minority populations, that is, lesbian, 
gay, and bisexual populations. ACF expects to collect and analyze data 
from a range of information collection efforts--including interviews 
with program administrators, program managers, healthy marriage and 
relationship programming experts, and focus groups with program 
applicants and program attendees--to propose methods and practices for 
serving such couples/individuals/youth.
    Respondents: Current healthy marriage program applicants and 
participants, program managers and facilitators, and experts in the 
field.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                   Total/annual      Number of    Average burden
                   Instrument                        number of     responses per     hours per     Annual burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Focus Group Guide for Program Applicants........              30               1             1.5              45
Focus Group Guide for Program Attendees.........              60               1             1.5              90
Focus Group Guide for Program Attendees.........              60               1             1.5              90
Interview Guide for Program Managers............               6               1               1               6
Interview Guide for Program Facilitators........              12               1               1              12
Interview Guide for Program Experts.............              12               1               1              12
----------------------------------------------------------------------------------------------------------------


[[Page 17049]]

    Estimated Total Annual Burden Hours: 255.
    In compliance with the requirements of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Administration for Children and 
Families is soliciting public comment on the specific aspects of the 
information collection described above. Copies of the proposed 
collection of information can be obtained and comments may be forwarded 
by writing to the Administration for Children and Families, Office of 
Planning, Research and Evaluation, 370 L'Enfant Promenade SW., 
Washington, DC 20447, Attn: OPRE Reports Clearance Officer. Email 
address: [email protected]. All requests should be 
identified by the title of the information collection.
    The Department specifically requests comments on (a) whether the 
proposed collection of information is necessary 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 proposed collection of 
information; (c) the quality, utility, and clarity of the information 
to be collected; and (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. 
Consideration will be given to comments and suggestions submitted 
within 60 days of this publication.

Karl Koerper,
Reports Clearance Officer.
[FR Doc. 2015-07316 Filed 3-30-15; 8:45 am]
BILLING CODE 4184-73-P

17048 Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices

industry #226 entitled ‘‘Target Animal entitled ‘‘Target Animal Safety Data and 4 p.m., Monday through Friday, and
Safety Data Presentation and Statistical Presentation and Statistical Analysis.’’ It will be posted to the docket at http://
Analysis.’’ The purpose of this is intended to provide recommendations www.regulations.gov.
document is to provide to industry regarding the presentation
recommendations to industry regarding and statistical analyses of TAS data V. Electronic Access
the presentation and statistical analyses submitted to CVM as part of a study Persons with access to the Internet
of target animal safety (TAS) data report to support approval of a new may obtain the draft guidance at either
submitted to the Center for Veterinary animal drug. These recommendations http://www.fda.gov/AnimalVeterinary/
Medicine (CVM) as part of a study apply to TAS data generated from both GuidanceComplianceEnforcement/
report to support approval of a new TAS and field effectiveness studies GuidanceforIndustry/default.htm or
animal drug. These recommendations conducted in companion animals (e.g.,
http://www.regulations.gov.
apply to TAS data generated from both dogs, cats, and horses) and food animals
TAS and field effectiveness studies (e.g., swine, ruminants, fish, and Dated: March 25, 2015.
conducted in companion animals (e.g., poultry). Leslie Kux,
dogs, cats, and horses) and food animals Associate Commissioner for Policy.
II. Significance of Guidance
(e.g., swine, ruminants, fish, and [FR Doc. 2015–07264 Filed 3–30–15; 8:45 am]
poultry). This level 1 draft guidance is being
issued consistent with FDA’s good BILLING CODE 4164–01–P
DATES: Although you can comment on
guidance practices regulation (21 CFR
any guidance at any time (see 21 CFR
10.115). The draft guidance, when
10.115(g)(5)), to ensure that the Agency DEPARTMENT OF HEALTH AND
finalized, will represent the current
considers your comment on this draft HUMAN SERVICES
thinking of FDA on ‘‘Target Animal
guidance before it begins work on the
Safety Data Presentation and Statistical
final version of the guidance, submit Administration for Children and
Analysis.’’ It does not establish any
either electronic or written comments Families
rights for any person and is not binding
on the draft guidance by June 1, 2015.
on FDA or the public. You can use an
ADDRESSES: Submit written requests for Proposed Information Collection
alternative approach if it satisfies the
single copies of the guidance to the Activity; Comment Request
requirements of the applicable statutes
Communications Staff (HFV–12), Center and regulations.
for Veterinary Medicine, Food and Drug Title: Same-sex relationships: Updates
Administration, 7519 Standish Pl., III. Paperwork Reduction Act of 1995 to Healthy Marriage and Relationship
Rockville, MD 20855. Send one self- This draft guidance refers to Education.
addressed adhesive label to assist that previously approved collections of OMB No.: New Collection
office in processing your requests. See information found in FDA regulations. Description: The Administration for
the SUPPLEMENTARY INFORMATION section These collections of information are
for electronic access to the draft Children and Families (ACF) will
subject to review by the Office of examine how healthy marriage
guidance document. Management and Budget (OMB) under
Submit electronic comments on the programs currently approach, and could
the Paperwork Reduction Act of 1995 approach, serving sexual minority
draft guidance to http:// (44 U.S.C. 3501–3520). The collections
www.regulations.gov. Submit written populations, that is, lesbian, gay, and
of information in 21 CFR part 514 have bisexual populations. ACF expects to
comments to the Division of Dockets been approved under OMB control
Management (HFA–305), Food and Drug collect and analyze data from a range of
number 0910–0032. information collection efforts—
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. IV. Comments including interviews with program
FOR FURTHER INFORMATION CONTACT: Interested persons may submit either administrators, program managers,
Virginia Recta, Center for Veterinary electronic comments regarding this healthy marriage and relationship
Medicine (HFV–164), Food and Drug document to http://www.regulations.gov programming experts, and focus groups
Administration, 7500 Standish Pl., or written comments to the Division of with program applicants and program
Rockville, MD 20855, 240–402–0840, Dockets Management (see ADDRESSES). It attendees—to propose methods and
virginia.recta@fda.hhs.gov. is only necessary to send one set of practices for serving such couples/
comments. Identify comments with the individuals/youth.
SUPPLEMENTARY INFORMATION:
docket number found in brackets in the Respondents: Current healthy
I. Background heading of this document. Received marriage program applicants and
FDA is announcing the availability of comments may be seen in the Division participants, program managers and
a draft guidance for industry #226 of Dockets Management between 9 a.m. facilitators, and experts in the field.

ANNUAL BURDEN ESTIMATES
Total/annual Number of Average Annual burden
Instrument number of responses per burden hours hours
respondents respondent per response
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Focus Group Guide for Program Applicants ................................................... 30 1 1.5 45
Focus Group Guide for Program Attendees .................................................... 60 1 1.5 90
Focus Group Guide for Program Attendees .................................................... 60 1 1.5 90
Interview Guide for Program Managers .......................................................... 6 1 1 6
Interview Guide for Program Facilitators ......................................................... 12 1 1 12
Interview Guide for Program Experts .............................................................. 12 1 1 12

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Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 17049

Estimated Total Annual Burden proposals, the disclosure of which believe she may violate requirements
Hours: 255. would constitute a clearly unwarranted under the FD&C Act relating to drug
In compliance with the requirements invasion of personal privacy. products. Ms. Fernandez was given
of section 3506(c)(2)(A) of the Name of Committee: National Institute of notice of the proposed debarment and
Paperwork Reduction Act of 1995, the Environmental Health Sciences Special an opportunity to request a hearing
Administration for Children and Emphasis Panel; NIH Loan Repayment within the timeframe prescribed by
Families is soliciting public comment Program (Clinical and Pediatric Researchers). regulation. Ms. Fernandez failed to
on the specific aspects of the Date: April 24, 2015. request a hearing. Ms. Fernandez’s
information collection described above. Time: 8:00 a.m. to 5:00 p.m. failure to request a hearing constitutes a
Copies of the proposed collection of Agenda: To review and evaluate contract waiver of her right to a hearing
information can be obtained and proposals. concerning this action.
comments may be forwarded by writing Place: National Institute of Environmental
Health Sciences, Keystone Building, 530 DATES: This order is effective March 31,
to the Administration for Children and 2015.
Davis Drive, Suite 3118, Research Triangle
Families, Office of Planning, Research Park, NC 27709, (Virtual Meeting). ADDRESSES: Submit applications for
and Evaluation, 370 L’Enfant Contact Person: RoseAnne M McGee, termination of debarment to the
Promenade SW., Washington, DC 20447, Scientific Review Officer, Scientific Review Division of Dockets Management (HFA–
Attn: OPRE Reports Clearance Officer. Branch, Division of Extramural Research and 305), Food and Drug Administration,
Email address: OPREinfocollection@ Training, Nat. Institute of Environmental
5630 Fishers Lane, Rm. 1061, Rockville,
acf.hhs.gov. All requests should be Health Sciences, P.O. Box 12233, MD EC–30,
Research Triangle Park, NC 27709 (919) 541– MD 20852.
identified by the title of the information
collection. 0752, mcgee1@niehs.nih.gov. FOR FURTHER INFORMATION CONTACT:
The Department specifically requests (Catalogue of Federal Domestic Assistance Kenny Shade, Division of Enforcement,
comments on (a) whether the proposed Program Nos. 93.115, Biometry and Risk Office of Enforcement and Import
collection of information is necessary Estimation—Health Risks from Operations, Office of Regulatory Affairs,
for the proper performance of the Environmental Exposures; 93.142, NIEHS Food and Drug Administration, 12420
Hazardous Waste Worker Health and Safety Parklawn Dr. (ELEM–4144), Rockville,
functions of the agency, including
Training; 93.143, NIEHS Superfund MD 20857, 301–796–4640.
whether the information shall have Hazardous Substances—Basic Research and
practical utility; (b) the accuracy of the SUPPLEMENTARY INFORMATION:
Education; 93.894, Resources and Manpower
agency’s estimate of the burden of the Development in the Environmental Health I. Background
proposed collection of information; (c) Sciences; 93.113, Biological Response to
the quality, utility, and clarity of the Environmental Health Hazards; 93.114, Section 306(b)(2)(B)(ii)(I) of the FD&C
information to be collected; and (d) Applied Toxicological Research and Testing, Act (21 U.S.C. 335a(b)(2)(B)(ii)(I))
ways to minimize the burden of the National Institutes of Health, HHS) permits debarment of an individual if
collection of information on Dated: March 25, 2015. FDA finds that the individual has been
respondents, including through the use convicted of a felony under Federal law
Carolyn Baum,
of automated collection techniques or for conduct which involves bribery,
Program Analyst, Office of Federal Advisory
other forms of information technology. payment of illegal gratuities, fraud,
Committee Policy.
Consideration will be given to perjury, false statement, racketeering,
[FR Doc. 2015–07249 Filed 3–30–15; 8:45 am]
comments and suggestions submitted blackmail, extortion, falsification or
BILLING CODE 4140–01–P
within 60 days of this publication. destruction of records, or interference
with, obstruction of an investigation
Karl Koerper, into, or prosecution of any criminal
Reports Clearance Officer. DEPARTMENT OF HEALTH AND
offense, and FDA finds, on the basis of
HUMAN SERVICES
[FR Doc. 2015–07316 Filed 3–30–15; 8:45 am] the conviction and other information,
BILLING CODE 4184–73–P Food and Drug Administration that such individual has demonstrated a
pattern of conduct sufficient to find that
[Docket No. FDA–2014–N–0563] there is reason to believe the individual
DEPARTMENT OF HEALTH AND may violate requirements under the
HUMAN SERVICES Odalys Fernandez: Debarment Order
FD&C Act relating to drug products.
AGENCY: Food and Drug Administration, On November 9, 2012, the U.S.
National Institutes of Health HHS. District Court for the Southern District
ACTION: Notice. of Florida entered judgment against Ms.
National Institute of Environmental
Fernandez after a jury found her guilty
Health Sciences; Notice of Closed SUMMARY: The U.S. Food and Drug of five counts of health care fraud in
Meeting Administration (FDA or Agency) is violation of 18 U.S.C. 1347, and one
Pursuant to section 10(d) of the issuing an order under the Federal count of conspiracy to commit health
Federal Advisory Committee Act, as Food, Drug, and Cosmetic Act (the care fraud in violation of 18 U.S.C.
amended (5 U.S.C. App.), notice is FD&C Act) debarring Odalys Fernandez 1349.
hereby given of the following meeting. from providing services in any capacity FDA’s finding that debarment is
The meeting will be closed to the to a person that has an approved or appropriate is based on the felony
public in accordance with the pending drug product application for a convictions referenced herein. The
asabaliauskas on DSK5VPTVN1PROD with NOTICES

provisions set forth in sections period of 6 years. FDA bases this order factual basis for these convictions is as
552b(c)(4) and 552b(c)(6), title 5 U.S.C., on a finding that Ms. Fernandez was follows: Ms. Fernandez was a registered
as amended. The contract proposals and convicted of five felony counts under nurse working for Ideal Home Health
the discussions could disclose Federal law for conduct involving Inc. (Ideal), which was a business in
confidential trade secrets or commercial health care fraud, and one count of Miami-Dade County, FL. Ideal
property such as patentable material, conspiracy to commit health care fraud, purportedly provided skilled nursing
and personal information concerning and that this pattern of conduct is services to Medicare beneficiaries who
individuals associated with the contract sufficient to find that there is reason to required home health services. As a

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Document Created: 2015-12-18 11:48:33
Document Modified: 2015-12-18 11:48:33

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		80 FR 17048

80 FR 17048 - Proposed Information Collection Activity; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESAdministration for Children and Families

Federal Register Volume 80, Issue 61 (March 31, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families