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]


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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
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