Submission for OMB Review; Comment Request; the Framingham Heart Study (FHS), 54886-54887 [2010-22472]

Download as PDF 54886 Federal Register / Vol. 75, No. 174 / Thursday, September 9, 2010 / Notices ANNUAL BURDEN ESTIMATES Number of responses per respondent Number of respondents Instrument Discussion Guide for Use with Researchers, Policy Experts, and State-level Coordinators ............................................................... Discussion Guide for Use with Program Directors .......................... Discussion Guide for Use with Program Staff ................................. 50 25 50 Average burden hours per response 1 1 1 1 2.5 2 Estimated Total Annual Burden Hours ..................................... Additional Information Copies of the proposed collection may be obtained 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. All requests should be identified by the title of the information collection. E-mail address: OPREinfocollection@acf.hhs.gov. OMB Comment OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202– 395–6974,Attn: Desk Officer for the Administration for Children and Families. Dated: September 1, 2010. Steven M. Hammer, OPRE Reports Clearance Officer. [FR Doc. 2010–22317 Filed 9–8–10; 8:45 am] BILLING CODE 4184–01–M Total burden hours 50 63 100 213 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; the Framingham Heart Study (FHS) Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. This proposed information collection was previously published in the Federal Register on May 10, 2010, pages 25863– 4, and allowed 60-days for public comment. No comments were received. 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: The Framingham Heart Study. Type of Information Request: Revision (OMB SUMMARY: Estimated number of respondents Type of respondents No. 0925–0216). Need and Use of Information Collection: The Framingham Heart Study will conduct examinations and morbidity and mortality follow-up for the purpose of studying the determinants of cardiovascular disease. Examinations will be conducted on the original, offspring, and Omni Cohorts. Morbidity and mortality follow-up will also occur in all of the cohorts (original, offspring, third generation, and Omni). Frequency of response: The participants will be contacted annually. Affected public: Individuals or households; businesses or other for profit; small businesses or organizations. Types of Respondents: Adult men and women; doctors and staff of hospitals and nursing homes. The annual reporting burden is as follows: Estimated Number of Respondents: 6,921; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: .88; and Estimated Total Annual Burden Hours Requested: 6,091. The annualized cost to respondents is estimated at: $222,040. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Estimated number of responses per respondent Average burden hours per response Estimated total annual burden hours requested Individuals (Participants and Informants) ........................................................ Physicians ........................................................................................................ 4461 2460 1 1 1.00 0.67 4442 1649 Totals ........................................................................................................ 6921 ........................ ........................ 6091 mstockstill on DSKH9S0YB1PROD with NOTICES (Note: Reported and calculated numbers differ slightly due to rounding.) 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 VerDate Mar<15>2010 17:24 Sep 08, 2010 Jkt 220001 the function of the agency, including 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; PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 (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 E:\FR\FM\09SEN1.SGM 09SEN1 Federal Register / Vol. 75, No. 174 / Thursday, September 9, 2010 / Notices 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: Dr. Gina Wei, Division of Cardiovascular Sciences, NHLBI, NIH, Two Rockledge Center, 6701 Rockledge Drive, MSC 7936, Bethesda, MD, 20892–7936, or call nontoll-free number (301) 435–0456, or email your request, including your address to: weig@nhlbi.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: September 1, 2010. Suzanne Freeman, NHLBI Project Clearance Liaison, National Institutes of Health. Michael Lauer, Director, DCVS, National Institutes of Health. [FR Doc. 2010–22472 Filed 9–8–10; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–E–0414] Determination of Regulatory Review Period for Purposes of Patent Extension; REPEL–CV AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for REPEL– CV and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device. ADDRESSES: Submit electronic comments to https:// www.regulations.gov. Submit written petitions along with three copies and written comments to the Division of mstockstill on DSKH9S0YB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:24 Sep 08, 2010 Jkt 220001 Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993– 0002, 301–796–3602. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B). FDA recently approved for marketing the medical device, REPEL–CV. REPEL– CV, a bioresorbable adhesion barrier, is indicated for reducing the severity of post-operative cardiac adhesions in pediatric patients who are likely to require reoperation via sternotomy. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for REPEL– CV (U.S. Patent No. 5,711,958) from SyntheMed, Inc., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated February 17, 2010, FDA advised the Patent and Trademark Office that this medical device had undergone a regulatory review period PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 54887 and that the approval of REPEL–CV represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that the FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for REPEL–CV is 4,023 days. Of this time, 3,256 days occurred during the testing phase of the regulatory review period, while 767 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) involving this device became effective: March 3, 1998. FDA has verified the applicant’s claim that the date the investigational device exemption (IDE) required under section 520(g) of the act for human tests to begin became effective March 3, 1998. 2. The date an application was initially submitted with respect to the device under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e): January 30, 2007. FDA has verified the applicant’s claim that the premarket approval application (PMA) for REPEL–CV (PMA P070005) was initially submitted January 30, 2007. 3. The date the application was approved: March 6, 2009. FDA has verified the applicant’s claim that PMA P070005 was approved on March 6, 2009. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,742 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments and ask for a redetermination by November 8, 2010. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by March 8, 2011. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Interested persons may submit to the Division of Dockets Management (see E:\FR\FM\09SEN1.SGM 09SEN1

Agencies

[Federal Register Volume 75, Number 174 (Thursday, September 9, 2010)]
[Notices]
[Pages 54886-54887]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22472]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Submission for OMB Review; Comment Request; the Framingham Heart
Study (FHS)

Summary: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Heart, Lung, and Blood Institute
(NHLBI), the National Institutes of Health (NIH) has submitted to the
Office of Management and Budget (OMB) a request for review and approval
the information collection listed below. This proposed information
collection was previously published in the Federal Register on May 10,
2010, pages 25863-4, and allowed 60-days for public comment. No
comments were received. 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: The Framingham Heart Study. Type of
Information Request: Revision (OMB No. 0925-0216). Need and Use of
Information Collection: The Framingham Heart Study will conduct
examinations and morbidity and mortality follow-up for the purpose of
studying the determinants of cardiovascular disease. Examinations will
be conducted on the original, offspring, and Omni Cohorts. Morbidity
and mortality follow-up will also occur in all of the cohorts
(original, offspring, third generation, and Omni). Frequency of
response: The participants will be contacted annually. Affected public:
Individuals or households; businesses or other for profit; small
businesses or organizations. Types of Respondents: Adult men and women;
doctors and staff of hospitals and nursing homes. The annual reporting
burden is as follows: Estimated Number of Respondents: 6,921; Estimated
Number of Responses per Respondent: 1; Average Burden Hours Per
Response: .88; and Estimated Total Annual Burden Hours Requested:
6,091. The annualized cost to respondents is estimated at: $222,040.
There are no Capital Costs to report. There are no Operating or
Maintenance Costs to report.

----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Estimated number of Average burden total annual
Type of respondents number of responses per hours per burden hours
respondents respondent response requested
----------------------------------------------------------------------------------------------------------------
Individuals (Participants and Informants)....... 4461 1 1.00 4442
Physicians...................................... 2460 1 0.67 1649
---------------------------------------------------------------
Totals...................................... 6921 .............. .............. 6091
----------------------------------------------------------------------------------------------------------------
(Note: Reported and calculated numbers differ slightly due to rounding.)

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 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

[[Page 54887]]

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: Dr. Gina Wei, Division of Cardiovascular
Sciences, NHLBI, NIH, Two Rockledge Center, 6701 Rockledge Drive, MSC
7936, Bethesda, MD, 20892-7936, or call non-toll-free number (301) 435-
0456, or e-mail your request, including your address to:
weig@nhlbi.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: September 1, 2010.
Suzanne Freeman,
NHLBI Project Clearance Liaison, National Institutes of Health.
Michael Lauer,
Director, DCVS, National Institutes of Health.
[FR Doc. 2010-22472 Filed 9-8-10; 8:45 am]
BILLING CODE 4140-01-P

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