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Code · REGISTER · 2008-02-05 · Food and Drug Administration, HHS · Notices

Notices. Notice

4,333 words·~20 min read·/register/2008/02/05/08-481

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BILLING CODE 4160-18-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0051] (formerly Docket No. 2007N-0422) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in the Medical Device Fellowship Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget
(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by March 6, 2008. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to *baguilar@omb.eop.gov* . All comments should be identified with the OMB control number 0910-0551. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley Jr.,Office of the Chief Information Officer (HFA-250), Food and Drug Administration,5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Application for Participation in the Medical Device Fellowship Program; (OMB Control Number 0910-0551)—Extension Sections 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 of title 5 of the United States Code, authorize Federal agencies to rate applicants for Federal jobs. Collecting applications for the Medical Device Fellowship Program will allow FDA's Center for Devices and Radiological Health
(CDRH)to easily and efficiently elicit and review information from students and health care professionals who are interested in becoming involved in CDRH activities. The process will reduce the time and cost of submitting written documentation to the agency and lessen the likelihood of applications being misrouted within the agency mail system. It will assist the agency in promoting and protecting the public health by encouraging outside persons to share their expertise with CDRH. In the **Federal Register** of November 9, 2007 (72 FR 63614), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimate of the burden for this collection of information is as follows: **Table 1.—Estimated Annual Reporting Burden** 1 5 U.S.C. Section/ FDA Form No. No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 1104, 1302, 3301, 3304, 3320, 3361, 3393, 3394/ Form No. 3608 250 1 250 1 250 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA based these estimates on the number of inquiries that have been received concerning the program and the number of requests for application forms over the past 3 years. Dated: January 30, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8-2068 Filed 2-4-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0048] (formerly Docket No. 2007N-0182) Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing that a collection of information entitled “Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank” has been approved by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In the **Federal Register** of October 19, 2007 (72 FR 59295), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0459. The approval expires on January 31, 2011. A copy of the supporting statement for this information collection is available on the Internet at *http://www.reginfo.gov/public/do/PRAMain* . Dated: January 30, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8-2076 Filed 2-4-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0050] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for the tracking of medical devices. DATES: Submit written or electronic comments on the collection of information by April 7, 2008. ADDRESSES: Submit electronic comments on the collection of information to *http://www.regulations.gov* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration,5600 Fishers Lane, Rockville, MD 20857, 301 827-1472. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget
(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:
(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;
(2)the accuracy of FDA'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 respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Medical Devices; Device Tracking—21 CFR Part 821 (OMB Control Number 0910-0442)—Extension Section 211 of the Food and Drug Administration Modernization Act (FDAMA) (Public Law 105-115) became effective on February 19, 1998. FDAMA amended the previous medical device tracking provisions under Section 519(e)(1) and
(2)of the Federal Food, Drug, and Cosmetic Act (the act) 21 U.S.C. 360i(e)(1) and
(2)and were added by the Safe Medical Devices Act of 1990
(SMDA)(Public Law 101-629). Unlike the tracking provisions under SMDA which required tracking of any medical device meeting certain criteria, FDAMA allows FDA discretion in applying tracking provisions to medical devices meeting certain criteria, and provides that tracking requirements for medical devices can be imposed only after FDA issues an order. In the **Federal Register** of February 8, 2002 (67 FR 5943), FDA issued a final rule which conformed existing tracking regulations to changes in tracking provisions effected by FDAMA under part 821 (21 CFR part 821). Section 519(e)(1) of the act, as amended by FDAMA, provides that FDA may require by order, that a manufacturer adopt a method for tracking a class II or III medical device, if the device meets one of the three following criteria:
(1)The failure of the device would be reasonably likely to have serious adverse health consequences,
(2)the device is intended to be implanted in the human body for more than 1 year (referred to as a “tracked implant”), or
(3)the device is life-sustaining or life-supporting (referred to as a “tracked l/s-l/s device”) and is used outside a device user facility. Tracked device information is collected to facilitate identifying the current location of medical devices and patients possessing those devices, to the extent that patients permit the collection of identifying information. Manufacturers and FDA (where necessary), use the data to:
(1)Expedite the recall of distributed medical devices that are dangerous or defective and
(2)facilitate the timely notification of patients or licensed practitioners of the risks associated with the medical device. In addition, the regulations include provisions for:
(1)Exemptions and variances;
(2)system and content requirements for tracking;
(3)obligations of persons other than device manufacturers, e.g., distributors; records and inspection requirements;
(4)confidentiality; and
(5)record retention requirements. Respondents for this collection of information are medical device manufacturers, importers, and distributors of tracked implants or tracked l/s-l/s devices used outside a device user facility. Distributors include multiple and final distributors, including hospitals. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency of Response Total Annual Responses Hours per Response Total Hours 821.2 and 821.30(e) 4 1 4 12 48 821.25(a) 1 1 1 76 76 821.25(d) 22 1 22 2 44 821.30(a) and
(b)17,000 72 1,222,725 0.1666 203,706 821.30(c)(2) 1 1 1 28 28 821.30(d) 17,000 15 259,186 0.1666 43,180 Total 247,082 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 2.—Estimated Average Annual Recordkeeping Burden** 1 21 CFR Section No. of Recordkeepers Annual Frequency of Recordkeeping Total Annual Records Hours per Record Total Hours 821.25(b) 229 46,260 10,593,433 0.2899 3,071,036 821.25(c) 229 1 229 63.0 14,430 821.25(c)(3) 229 1,124 257,454 0.2899 74,636 **Total** 3,160,102 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The annual hourly reporting burden for respondents involved with medical device tracking is estimated to be 247,082 hours, and the annual recordkeeping burden for these respondents is estimated to be 3,160,102 hours. These figures have been rounded up. The burden estimates cited in tables 1 and 2 of this document are based primarily upon the data and methods provided in FDA's assessment for fiscal year
(FY)1999 entitled “A Cost Assessment of Medical Device Tracking.” Using implantation procedures from the National Center for Health Statistics, FDA applied a 2-percent annual growth rate to estimate the number of procedures for tracked implant devices for FY1997 through FY2006. This assessment also used unit shipment data in combination with various growth rates to estimate annual sales distribution for the tracked l/s-l/s devices over the same time period. In addition, the assessment also estimated the burden on industry for developing and maintaining tracking systems for these medical devices for FY1997 through FY2006. For the annual recordkeeping burden, the number of respondent medical device manufacturers subject to device tracking is estimated to be 229 and is based on data from FDA's manufacturers database. FDA issued tracking orders to 20 additional medical device manufacturers during the time period for FY2002 through FY2004. Under § 821.25(c), the additional medical device manufacturers collectively bear a one-time recordkeeping burden of 10,560 hours to develop a medical device tracking system. FDA's estimate of 17,000 medical device distributor respondents contained in this assessment, are derived from Dun & Bradstreet sources on medical equipment wholesalers, retailers, home care dealers, and rental companies. Health Forum, an American Hospital Association Company, provided statistics on hospitals. Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only. Dated: January 30, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8-2078 Filed 2-4-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2008N-0016] Agency Information Collection Activities; Proposed Collection; Comment Request; Additional Listing Information for Medical Device Registration and Listing AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits public comments on the reporting and recordkeeping burden associated with the paperwork requirements under § 807.31 (21 CFR 807.31), which requires device establishments to retain and, upon FDA's specific request, submit certain additional listing information. DATES: Submit written or electronic comments on the collection of information by April 7, 2008. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.regulations.gov* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472 SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget
(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:
(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;
(2)the accuracy of FDA'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 respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Additional Listing Information for Medical Device Registration and Listing—21 CFR 80.31; (OMB Control Number 0910-0387)—Extension The Food and Drug Administration Amendments Act of 2007 (the 2007 Amendments), enacted September 27, 2007, requires that device establishment registrations and listings under 21 U.S.C. 360(p) (including the submission of updated information), be submitted to the Secretary of Health and Human Services (the Secretary) by electronic means, unless the Secretary grants a request for waiver of the requirement because the use of electronic means is not reasonable for the person requesting the waiver. See section 224 of the 2007 Amendments. The 2007 Amendments provides for an October 1, 2007, effective date by which FDA expects approximately 30,000 establishments to begin registering. FDA is seeking OMB approval for the information collected by electronic means. Registration by electronic means for device establishments will mean replacement of FDA Forms 2891 and 2891a, “Registration of Device Establishment” and FDA Form 2892 “Medical Device Listing,” with electronic versions. However, for OMB approval of the extension request for this collection of information, FDA is revising the scope to address only the reporting and recordkeeping requirements by non-electronic means as described in this document and set forth under § 807.31 for “ Additional Listing Information.” To reflect the revised scope of this collection of information, FDA has modified the title. Under § 807.31(a) through (d), each owner or operator is required to maintain an historical file containing the labeling and advertisements in use on the date of initial listing, and in use after October 10, 1978, but before the date of initial listing. The owner or operator must maintain in the historical file any labeling or advertisements in which a material change has been made anytime after initial listing, but may discard labeling and advertisements from the file 3 years after the date of the last shipment of a discontinued device by an owner or operator. Along with the recordkeeping requirements, under § 807.31(e), the owner or operator must be prepared to submit to FDA copies of :
(1)All device labeling,
(2)all device labeling and representative advertising, or
(3)only representative package inserts, depending upon whether the device is subject to the regulatory controls under Sections 514 or 515 of Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d and 360e, respectively), or restrictions imposed by 21 CFR 801.109 or otherwise by section 520(e) of the act. The information collected under these provisions is used by FDA to identify:
(1)Firms subject to FDA's regulations,
(2)geographic distribution in order to effectively allocate FDA's field resources for these inspections, and
(3)the class of the device that determines the frequency of inspection. As a result, when complications occur with a particular device or component, all manufacturers of similar or related devices can easily be identified. The likely respondents to this information collection are domestic and foreign device establishments who must register and submit a device list to FDA, e.g., establishments engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency of Response Total Annual Responses Hours per Response Total Hours 807.31(e) 200 1 200 .50 100 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 2.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section No. of Recordkeepers Annual Frequency of Recordkeeping Total Annual Records Hours per Record Total Hours 807.31(a) through (d ) 16,200 4 64,800 .50 32,400 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The annual respondent reporting burden for device establishment registrations and listing is estimated to be 100 hours and the annual respondent recordkeeping burden is estimated to be 32,400 hours. The estimates cited in tables 1 and 2 of this documet are based primarily on the annual FDA accomplishment report, which includes actual FDA registration and listing data derived for fiscal year
(FY)2006. These estimates are also based on FDA estimates of FY 2006 data from current systems and conversations with industry and trade association representatives. FDA anticipates reviewing annually, 200 historical files. Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through the FDMS only. Dated: January 30, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8-2079 Filed 2-4-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review: Comment Request Questionnaire Cognitive Interview and Pretesting (ARP/DCCPS/NCI) *Summary:* Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), 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 November 26, 2007 (Vol. 72, No. 226, p. 65969) and allowed 60 days for public comment. No public 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:* Questionnaire Cognitive Interview and Pretesting. *Type of Information Collection Request:* New. *Need and Use of Information Collection:* The purpose of the data collection is to conduct cognitive interviews, focus groups, Pilot household interviews, and experimental research in laboratory and field settings, both for applied questionnaire evaluation and more basic research on response errors in surveys. The most common evaluation method is the cognitive interview, in which a questionnaire design specialist interviews a volunteer participant. The interviewer administers the draft survey questions as written, but also probes the participant in depth about interpretations of questions, recall processes used to answer them, and adequacy of response categories to express answers, while noting points of confusion and errors in responding. Interviews are generally conducted in small rounds of 10-15 interviews. When possible, cognitive interviews are conducted in the survey's intended mode of administration. Cognitive interviewing provides useful information on questionnaire performance at minimal cost and respondent burden. Similar methodology has been adopted by other federal agencies, as well as by academic and commercial survey organizations. There are no costs to respondents other than their time. *Frequency of Response:* Once. *Affected Public:* Individuals or households. Type of respondents Project Estimated number of respondents Estimated number of responses per respondent Average burden hours per response Estimated annual burden hours requested Questionnaire Development Volunteers
(1)Survey questionnaire development 200 1 1.25 (75 minutes) 250.0 General Volunteers
(2)Research on the cognitive aspects of survey methodology 100 1 1.25 (75 minutes) 125.0 Computer User Volunteers
(3)Research on computer-user interface design 100 1 1.25 (75 minutes) 125.0 Household Interview Volunteers
(4)Pilot Household interviews 200 1 0.5 (30 minutes) 100.0 Total 600 600.0 The estimated total annual burden hours requested is 600. There are no annualized costs to respondents. The annualized costs to the Federal Government are estimated at $264,000 and include cost of NCI staff to plan, conduct, and analyze outcomes of questionnaire development, $50 payment of pretest participants, contracting for pretesting activities and research, travel costs, and additional materials needed to conduct and recruit participants for the research. 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 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, New Executive Office Building, Room 10235, Washington, DC 20503, 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. Gordon Willis, PhD., Cognitive Psychologist, Applied Research Program, DCCPS, NCI/NIH, 6130 Executive Blvd., MSC 7344, EPN 4005, Bethesda, MD 20892 or call non-toll-free number 301-594-6652 or e-mail your request, including your address to: *willis@mail.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: January 28, 2008. Vivian Horovitch-Kelley, NCI Project Clearance Liaison, National Institutes of Health. [FR Doc. E8-2029 Filed 2-4-08; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel MRI Imaging. *Date:* March 5, 2008. *Time:* 12 p.m. to 3 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). *Contact Person:* Ruixia Zhou, PhD, Scientific Review Officer, 6707 Democracy Boulevard, Democracy Two Building, Suite 957, Bethesda, MD 20892,
(301)496-4773, *zhour@mail.nih.gov.* Dated: January 29, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 08-481 Filed 2-4-08; 8:45 am]
Connectionstraces to 8
6 references not yet in our index
  • 44 USC 3501-3520
  • 5 CFR 1320.3(c)
  • 21 CFR 821
  • Pub. L. 105-115
  • Pub. L. 101-629
  • 21 CFR 807.31
Citation graph
cites case law
Notices
Notice
Cite44 USC 3501-3520
Cite5 CFR 1320.3(c)
Cite21 CFR 821
Pub. L.Pub. L. 105-115
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