Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards, 15726-15727 [E9-7782]
Download as PDF
15726
Federal Register / Vol. 74, No. 65 / Tuesday, April 7, 2009 / Notices
Trans No.
Acquiring
Acquired
Entities
Transactions Granted Early Termination—02/25/2009
20090294 ................
General Electric Company ...................
ATP Oil & Gas Corporation .................
ATP Infrastructure Partners, L.P.
Transactions Granted Early Termination—02/27/2009
20090306 ................
University of Southern California .........
Tenet Healthcare Corporation ..............
Tenet HealthSystem Norris, Inc.; USC
University Hospital, Inc.
Transactions Granted Early Termination—03/02/2009
20090143 ................
Intercontinental Exchange, Inc. ............
The Clearing Corporation .....................
The Clearing Corporation
Transactions Granted Early Termination—03/03/2009
20090287 ................
20090307 ................
Novartis Pharma AG ............................
Baker Brothers Life Sciences, L.P. ......
Portola Pharmaceuticals, Inc. ..............
Seattle Genetics, Inc. ...........................
Portola Pharmaceuticals, Inc.
Seattle Genetics, Inc.
Transactions Granted Early Termination—03/09/2009
20090317 ................
20090318 ................
20090322 ................
DCP Midstream Partners, LP ..............
DCP Midstream Partners, LP ..............
Roger Penske ......................................
ConocoPhillips ......................................
Spectra Energy Corp. ..........................
General Electric Company ...................
DCP East Texas Holdings, LLC
DCP East Texas Holdings, LLC
Penske Truck Leasing Co., L.P.
Transactions Granted Early Termination—03/11/2009
20090321 ................
Marsh & McLennan Companies, Inc. ..
Callan Associates Inc. ..........................
Callan Associates Inc.
Transactions Granted Early Termination—03/13/2009
20090263 ................
William Goldring ...................................
Constellation Brands, Inc. ....................
20090327 ................
20090333 ................
Mascolo Brothers Limited ....................
Fidelity National Financial, Inc. ............
Toni & Guy Holdings, Inc. ....................
Wind Point Partners V, L.P. .................
20090336 ................
Newport Global Opportunities Fund
L.P.
Wind Point Partners V, L.P. .................
Barton Brands of California, Inc.; Barton Distillers Import Corp.; Constellation Spirits Inc.
Toni & Guy Holdings, Inc.
VI Acquisition Corp.; VICORP Restaurants, Inc.
VI Acquisition Corp.; VICORP Restaurants, Inc.
Transactions Granted Early Termination—03/16/2009
20090311 ................
20090313 ................
Fairholme Funds, Inc. ..........................
Amphenol Corporation .........................
FOR FURTHER INFORMATION CONTACT:
Sandra M. Peay, Contact Representative
or Renee Hallman, Contact
Representative, Federal Trade
Commission, Premerger Notification
Office, Bureau of Competition, Room H–
303, Washington, DC 20580, (202) 326–
3100.
By Direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. E9–7551 Filed 4–6–09; 8:45 am]
BILLING CODE 6750–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Guidance on the Genetic Information
Nondiscrimination Act: Implications
for Investigators and Institutional
Review Boards
AGENCY: Office for Human Research
Protections, Office of Public Health and
Science, Office of the Secretary, HHS.
VerDate Nov<24>2008
17:13 Apr 06, 2009
Jkt 217001
ACTION:
The St. Joe Company ..........................
General Electric Company ...................
Notice.
SUMMARY: The Office for Human
Research Protections (OHRP), Office of
Public Health and Science, is
announcing the availability of a
guidance document entitled, ‘‘Guidance
on the Genetic Information
Nondiscrimination Act: Implications for
Investigators and Institutional Review
Boards.’’ The guidance document
provides OHRP’s first formal guidance
on this topic. The document, which is
available on the OHRP Web site at
https://www.hhs.gov/ohrp/
humansubjects/guidance/gina.html and
https://www.hhs.gov/ohrp/
humansubjects/guidance/gina.pdf, is
intended primarily for investigators who
conduct, and institutional review boards
(IRB) that review, non-exempt human
subjects research involving genetic
testing or collection of genetic
information (hereinafter referred to as
‘‘genetic research’’). The guidance
document provides background on
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
The St. Joe Company.
Times Microwave Systems, Inc.
protections provided by the Genetic
Information Nondiscrimination Act of
2008 (GINA) and discusses some of the
implications of GINA for investigators
who conduct, and IRBs that review,
genetic research, particularly with
respect to the criteria for IRB approval
of research and the requirements for
obtaining informed consent under the
Department of Health and Human
Services (HHS) regulations for the
protection of human subjects (45 CFR
part 46).
DATES: Comments on OHRP guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled, ‘‘Guidance on the Genetic
Information Nondiscrimination Act:
Implications for Investigators and
Institutional Review Boards,’’ to the
Division of Policy and Assurances,
Office for Human Research Protections,
1101 Wootton Parkway, Suite 200,
Rockville, MD 20852. Send one selfaddressed adhesive label to assist that
E:\FR\FM\07APN1.SGM
07APN1
Federal Register / Vol. 74, No. 65 / Tuesday, April 7, 2009 / Notices
office in processing your request, or fax
your request to 301–402–2071. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance document. Submit written
comments to GINA GUIDANCE
COMMENTS, OHRP, 1101 Wootton
Parkway, Suite 200, Rockville, MD
20852. Comments also may be sent via
e-mail to ohrp@hhs.gov or via facsimile
at 240–453–6909. Comments received,
including any personal information,
will be made available to the public
upon request.
FOR FURTHER INFORMATION CONTACT:
Michael A. Carome, M.D., Captain, U.S.
Public Health Service, OHRP, 1101
Wootton Parkway, Suite 200, Rockville,
MD 20852, 240–453–6900; e-mail
Michael.Carome@hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
OHRP, Office of Public Health and
Science, is announcing the availability
of a guidance document entitled,
‘‘Guidance on the Genetic Information
Nondiscrimination Act: Implications for
Investigators and Institutional Review
Boards.’’ The guidance document
provides OHRP’s first formal guidance
on this topic. The document applies to
non-exempt human subjects research
conducted or supported by HHS and is
intended primarily for investigators who
conduct, and IRBs that review, genetic
research.
The guidance document provides
some general background information
regarding GINA and discusses some of
the implications of GINA with respect to
the criteria for IRB approval of research
and the requirements for obtaining
informed consent under the HHS
regulations for the protection of human
subjects (45 CFR part 46).
II. Electronic Access
Persons with access to the Internet
may obtain the guidance document on
OHRP’s Web site at https://www.hhs.gov/
ohrp/humansubjects/guidance/
gina.html and https://www.hhs.gov/ohrp/
humansubjects/guidance/gina.pdf.
III. Request for Comments
Interested persons may submit
comments regarding this guidance
document to OHRP at any time. Please
see the ADDRESSES section for
information on where to submit written
comments.
VerDate Nov<24>2008
17:13 Apr 06, 2009
Jkt 217001
Dated: April 1, 2009.
Jerry Menikoff,
Director, Office for Human Research
Protections.
[FR Doc. E9–7782 Filed 4–6–09; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Cross-Site Evaluation of the
Infant Adoption Awareness Training
Program for Projects Initially Funded in
Fiscal Year 2006.
OMB No.: New Collection.
Description: The Administration for
Children and Families (ACF), Children’s
Bureau (CB), will conduct the Cross-Site
Evaluation of the Infant Adoption
Awareness Training Program (IAATP).
Title XII, Subtitle A, of the Children’s
Health Act of 2000 (CHA) authorizes the
Department of Health and Human
Services to make Infant Adoption
Awareness Training grants available to
national, regional, and local adoption
organizations for the purposes of
developing and implementing programs
that train the staff of public and nonprofit private health service
organizations to provide adoption
information and referrals to pregnant
women on an equal basis with all other
courses of action included in nondirective counseling of pregnant
women. Participants in the training
include individuals who provide
pregnancy or adoption information and
those who will provide such services
after receiving the training, with Title X
(relating to voluntary family planning
projects), Section 330 (relating to
community health centers, migrant
health centers, and centers serving
homeless individuals and residents of
public housing), and CHA-funded
school-based health centers, receiving
priority to receive the training. A total
of six organizations were awarded
IAATP funding in 2006.
Section 1201(a)(2)(A) of the IAATP
legislation requires grantees to develop
and deliver trainings that are consistent
with the Best Practice Guidelines for
Infant Adoption Awareness Training.
The IAATP guidelines address training
goals, basic skills, curriculum and
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
15727
training structure. A complete
description of the guidelines is available
at https://www.acf.hhs.gov/programs/cb/
programs_fund/discretionary/iaatp.htm.
In addition, grantees are required to
conduct local evaluation of program
outcomes and participate in the national
evaluation of the extent to which IAATP
training objectives are met. The Infant
Adoption Awareness Training Program:
Trainee Survey is the primary data
collection instrument for the national
cross-site evaluation. Respondents will
complete the survey prior to receiving
training and approximately 90 days after
the training to assess the extent to
which trainees demonstrate sustained
gains in their knowledge about
adoption, and to determine the impact
of the training on their subsequent work
with pregnant women.
1. Do health care workers who
participate in the IAATP training:
Demonstrate enhanced knowledge,
attitudes, skills, and behaviors with
respect to adoption counseling
following completion of the program?
Provide adoption information to
pregnant women on an equal basis with
other pregnancy planning options?
Demonstrate enhanced awareness of
community adoption-related resources
and refer expectant mothers to them as
needed?
2. Are trainees more confident about
discussing all three pregnancy planning
options (parenting, abortion, and
adoption) in a non-directive counseling
style than they were prior to
participating in the training? Cross-site
evaluation data will be collected on an
annual basis throughout the five-year
funding period. Pre-test and follow-up
versions of the survey are expected to
require approximately 10 to 15 minutes
to complete. Estimated response time
for the follow-up survey includes time
for respondents to access the Web-based
survey, complete the survey online, and
electronically submit the survey.
Respondents will not need to
implement a recordkeeping system or
compile source data in order to
complete the survey. Where possible,
fields in the follow-up version of the
survey will be pre-filled with static data
from the respondents pre-test (e.g.,
demographics, agency type) in order to
further expedite completion of the
survey and minimize respondent
burden.
Respondents: Infant Adoption
Awareness Program Trainees.
E:\FR\FM\07APN1.SGM
07APN1
Agencies
[Federal Register Volume 74, Number 65 (Tuesday, April 7, 2009)]
[Notices]
[Pages 15726-15727]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-7782]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Guidance on the Genetic Information Nondiscrimination Act:
Implications for Investigators and Institutional Review Boards
AGENCY: Office for Human Research Protections, Office of Public Health
and Science, Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Office for Human Research Protections (OHRP), Office of
Public Health and Science, is announcing the availability of a guidance
document entitled, ``Guidance on the Genetic Information
Nondiscrimination Act: Implications for Investigators and Institutional
Review Boards.'' The guidance document provides OHRP's first formal
guidance on this topic. The document, which is available on the OHRP
Web site at https://www.hhs.gov/ohrp/humansubjects/guidance/gina.html
and https://www.hhs.gov/ohrp/humansubjects/guidance/gina.pdf, is
intended primarily for investigators who conduct, and institutional
review boards (IRB) that review, non-exempt human subjects research
involving genetic testing or collection of genetic information
(hereinafter referred to as ``genetic research''). The guidance
document provides background on protections provided by the Genetic
Information Nondiscrimination Act of 2008 (GINA) and discusses some of
the implications of GINA for investigators who conduct, and IRBs that
review, genetic research, particularly with respect to the criteria for
IRB approval of research and the requirements for obtaining informed
consent under the Department of Health and Human Services (HHS)
regulations for the protection of human subjects (45 CFR part 46).
DATES: Comments on OHRP guidance documents are welcome at any time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled, ``Guidance on the Genetic Information
Nondiscrimination Act: Implications for Investigators and Institutional
Review Boards,'' to the Division of Policy and Assurances, Office for
Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville,
MD 20852. Send one self-addressed adhesive label to assist that
[[Page 15727]]
office in processing your request, or fax your request to 301-402-2071.
See the SUPPLEMENTARY INFORMATION section for information on electronic
access to the guidance document. Submit written comments to GINA
GUIDANCE COMMENTS, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD
20852. Comments also may be sent via e-mail to ohrp@hhs.gov or via
facsimile at 240-453-6909. Comments received, including any personal
information, will be made available to the public upon request.
FOR FURTHER INFORMATION CONTACT: Michael A. Carome, M.D., Captain, U.S.
Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200,
Rockville, MD 20852, 240-453-6900; e-mail Michael.Carome@hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
OHRP, Office of Public Health and Science, is announcing the
availability of a guidance document entitled, ``Guidance on the Genetic
Information Nondiscrimination Act: Implications for Investigators and
Institutional Review Boards.'' The guidance document provides OHRP's
first formal guidance on this topic. The document applies to non-exempt
human subjects research conducted or supported by HHS and is intended
primarily for investigators who conduct, and IRBs that review, genetic
research.
The guidance document provides some general background information
regarding GINA and discusses some of the implications of GINA with
respect to the criteria for IRB approval of research and the
requirements for obtaining informed consent under the HHS regulations
for the protection of human subjects (45 CFR part 46).
II. Electronic Access
Persons with access to the Internet may obtain the guidance
document on OHRP's Web site at https://www.hhs.gov/ohrp/humansubjects/guidance/gina.html and https://www.hhs.gov/ohrp/humansubjects/guidance/gina.pdf.
III. Request for Comments
Interested persons may submit comments regarding this guidance
document to OHRP at any time. Please see the ADDRESSES section for
information on where to submit written comments.
Dated: April 1, 2009.
Jerry Menikoff,
Director, Office for Human Research Protections.
[FR Doc. E9-7782 Filed 4-6-09; 8:45 am]
BILLING CODE 4150-36-P