Submission for OMB Review; Comment Request; Application for the Pharmacology Research Associate Program, 44266-44267 [2010-18509]

Download as PDF 44266 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Notices The annualized cost to respondents is estimated at: $13,500. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report. Type of respondents Estimated number of respondents Estimated number of responses per respondent Average burden hours per response Estimated annual burden hours requested Primary care physicians .................................................................................. 80 3 0.75 180 Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Quandra Scudder, Project Officer, NIH/NIDA/CCTN, Room 3105, MSC 9557, 6001 Executive Boulevard, Bethesda, MD 20892–9557 or e-mail your request, including your address to scudderq@nida.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: Dated: July 21, 2010. Mary Affeldt, Executive Officer (OM Director), NIDA. [FR Doc. 2010–18511 Filed 7–27–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; Application for the Pharmacology Research Associate Program Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of General Medical Sciences (NIGMS), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on May 18, 2010, pages 27789– 27790, and allowed 60 days for public comment. One comment was received on 6/25/2010. The public respondent requested that eligibility for this program be offered to American citizens only. As stated in A.1., Justification, of the Supporting Statement A, applicants for this program must be U.S. citizens or permanent residents of the United States who have been awarded a terminal degree, or who have been certified by a university as meeting all the requirements leading to a doctorate may be hired as PRAT Fellows. The SUMMARY: Estimated number of responses per respondent Type and number of respondents sroberts on DSKD5P82C1PROD with NOTICES Applicants—25 ................................................................................................. Referees—75 ................................................................................................... Total Number of Respondents: 100. Total Number of Responses: 100. Total Hours: 331.25. The annualized cost to respondents is estimated at: Applicants: $10,250.00. VerDate Mar<15>2010 19:05 Jul 27, 2010 Jkt 220001 Estimated total responses 1 1 Referees: $6,562.50. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Application for the Pharmacology Research Associate Program. Type of Information Collection Request: Extension of a currently approved collection. Need and Use of Information Collection: The Pharmacology Research Associate (PRAT) Program will use the applicant and referee information to award opportunities for training and experience in laboratory or clinical investigation to individuals with a Ph.D. degree in pharmacology or a related science, M.D., or other professional degree through appointments as PRAT Fellows at the National Institutes of Health or the Food and Drug Administration. The goal of the program is to develop leaders in pharmacological research for key positions in academic, industrial, and Federal research laboratories. Frequency of Response: Once a year. Affected Public: Individuals or households; Businesses or other forprofit. Type of Respondents: Applicants and Referees. The annual reporting burden is as follows: 25 75 Average burden hours per responses 8.00 1.75 Estimated total annual burden hours requested 200 131.25 public and affected agencies should address one or more of the following points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the function of the agency, including E:\FR\FM\28JYN1.SGM 28JYN1 Federal Register / Vol. 75, No. 144 / Wednesday, July 28, 2010 / Notices whether the information will have practical utility; (2) evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) enhance the quality, utility, and clarity of the information to be collected; and (4) minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202–395–6974, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Ms. Kimberly Allen, NIGMS, NIH, Natcher Building, Room 2AN–18H, 45 Center Drive, MSC 6200, Bethesda, MD 20892– 6200, or call non-toll-free number 301– 594–2755 or e-mail your request, including your address to allenki@nigms.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. Dated: July 19, 2010. Sally Lee, Executive Officer, NIGMS, National Institute of General Medical Sciences, National Institutes of Health. [FR Doc. 2010–18509 Filed 7–27–10; 8:45 am] BILLING CODE 4140–01–P Food and Drug Administration sroberts on DSKD5P82C1PROD with NOTICES [Docket No. FDA–2009–N–0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period Food and Drug Administration, HHS. ACTION: Notice; reopening of comment period. The Food and Drug Administration (FDA) is reopening until SUMMARY: VerDate Mar<15>2010 19:05 Jul 27, 2010 Jkt 220001 Submit either electronic or written comments by September 7, 2010. DATES: Submit electronic comments 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. ADDRESSES: III. How to Submit Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed 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. Dated: July 22, 2010. David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. [FR Doc. 2010–18406 Filed 7–27–10; 8:45 am] BILLING CODE 4160–01–S FOR FURTHER INFORMATION CONTACT: Robert J. DeLuca, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. G214, Silver Spring, MD 20993–0002, e-mail: Robert.DeLuca@fda.hhs.gov, 301–796– 6630. In the Federal Register of April 5, 2010 (75 FR 17093), FDA published a notice announcing the availability of draft special controls guidance documents for 11 neurological and physical medicine devices. Interested persons were originally given until July 6, 2010, to comment on the draft guidance documents. The agency expressed specific interest in comments on the types of claims appropriate for devices included within the 11 classifications and, for devices that remain subject to premarket review, the data sponsors should submit to support those claims. Following publication of the April 5, 2010, notice, FDA received requests to allow interested persons additional time to comment. The requests asserted that the 90-day time period was insufficient to respond fully to FDA’s specific requests for comments and to allow potential respondents to thoroughly evaluate and address pertinent issues. The agency has considered the requests and is reopening the comment period until September 7, 2010. The agency believes the additional comment period allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues. Frm 00054 Fmt 4703 Sfmt 4703 National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. I. Background PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: SUPPLEMENTARY INFORMATION: II. Request for Comments DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: September 7, 2010, the comment period for the notice that appeared in the Federal Register of April 5, 2010 (75 FR 17143). In the notice, FDA requested comments on draft guidance documents for 11 neurological and physical medicine devices. FDA is reopening the comment period to allow further comment and to receive any new information. 44267 The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: (301) 496–7057; fax: (301) 402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. SUMMARY: Software System With Applications in Clinical Prognosis, Personalized Medicine and Clinical Research Description of Invention: Available for licensing is software that can provide prognostic information for different diseases and in particular for cancer. The software can determine whether a particular genotype has a significant association with survival time for an E:\FR\FM\28JYN1.SGM 28JYN1

Agencies

[Federal Register Volume 75, Number 144 (Wednesday, July 28, 2010)]
[Notices]
[Pages 44266-44267]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-18509]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request; Application for the 
Pharmacology Research Associate Program

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institute of General Medical 
Sciences (NIGMS), the National Institutes of Health (NIH) has submitted 
to the Office of Management and Budget (OMB) a request to review and 
approve the information collection listed below. This proposed 
information collection was previously published in the Federal Register 
on May 18, 2010, pages 27789-27790, and allowed 60 days for public 
comment. One comment was received on 6/25/2010. The public respondent 
requested that eligibility for this program be offered to American 
citizens only. As stated in A.1., Justification, of the Supporting 
Statement A, applicants for this program must be U.S. citizens or 
permanent residents of the United States who have been awarded a 
terminal degree, or who have been certified by a university as meeting 
all the requirements leading to a doctorate may be hired as PRAT 
Fellows. The purpose of this notice is to allow an additional 30 days 
for public comment. The National Institutes of Health may not conduct 
or sponsor, and the respondent is not required to respond to, an 
information collection that has been extended, revised, or implemented 
on or after October 1, 1995, unless it displays a currently valid OMB 
control number.
    Proposed Collection: Title: Application for the Pharmacology 
Research Associate Program.
    Type of Information Collection Request: Extension of a currently 
approved collection.
    Need and Use of Information Collection: The Pharmacology Research 
Associate (PRAT) Program will use the applicant and referee information 
to award opportunities for training and experience in laboratory or 
clinical investigation to individuals with a Ph.D. degree in 
pharmacology or a related science, M.D., or other professional degree 
through appointments as PRAT Fellows at the National Institutes of 
Health or the Food and Drug Administration. The goal of the program is 
to develop leaders in pharmacological research for key positions in 
academic, industrial, and Federal research laboratories.
    Frequency of Response: Once a year.
    Affected Public: Individuals or households; Businesses or other 
for-profit.
    Type of Respondents: Applicants and Referees.
    The annual reporting burden is as follows:

----------------------------------------------------------------------------------------------------------------
                                                     Estimated                                       Estimated
                                                     number of       Estimated        Average      total annual
         Type and number of respondents            responses per       total       burden hours    burden hours
                                                    respondent       responses     per responses     requested
----------------------------------------------------------------------------------------------------------------
Applicants--25..................................               1              25            8.00             200
Referees--75....................................               1              75            1.75          131.25
----------------------------------------------------------------------------------------------------------------

    Total Number of Respondents: 100.
    Total Number of Responses: 100.
    Total Hours: 331.25.
    The annualized cost to respondents is estimated at:
    Applicants: $10,250.00.
    Referees: $6,562.50.
    There are no Capital Costs, Operating Costs, and/or Maintenance 
Costs to report.
    Request for Comments: Written comments and/or suggestions from the 
public and affected agencies should address one or more of the 
following points: (1) Evaluate whether the proposed collection of 
information is necessary for the proper performance of the function of 
the agency, including

[[Page 44267]]

whether the information will have practical utility; (2) evaluate the 
accuracy of the agency's estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (3) enhance the quality, utility, and clarity of 
the information to be collected; and (4) minimize the burden of the 
collection of information on those who are to respond, including the 
use of appropriate automated, electronic, mechanical, or other 
technological collection techniques or other forms of information 
technology.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the: Office of Management and Budget, Office of Regulatory 
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, 
Attention: Desk Officer for NIH. To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact: Ms. Kimberly Allen, NIGMS, NIH, Natcher Building, 
Room 2AN-18H, 45 Center Drive, MSC 6200, Bethesda, MD 20892-6200, or 
call non-toll-free number 301-594-2755 or e-mail your request, 
including your address to allenki@nigms.nih.gov.
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30 days 
of the date of this publication.

    Dated: July 19, 2010.
Sally Lee,
Executive Officer, NIGMS, National Institute of General Medical 
Sciences, National Institutes of Health.
[FR Doc. 2010-18509 Filed 7-27-10; 8:45 am]
BILLING CODE 4140-01-P
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