54638 Federal Register / Vol. 75, No. 173 / Wednesday, September 8, 2010 / Notices 

approval (PMA) requirements (section 

515 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 360e)). 

On December 4, 2000, at a public 

meeting of FDA’s Circulatory System 

Devices Panel (the Panel), the Panel 

recommended that PTCA catheters, 

other than cutting/scoring PTCA 

catheters and standard PTCA catheters 

for the treatment of in-stent restenosis 

and/or post-deployment stent 

expansion, be reclassified from class III 

to class II, when indicated for balloon 

dilatation of a hemodynamically 

significant coronary artery or bypass 

graft stenosis in patients evidencing 

coronary ischemia for the purpose of 

improving myocardial perfusion, or for 

treatment of acute myocardial 

infarction. The Panel recommended a 

guidance document, labeling, and 

postmarket surveillance as special 

controls. 

FDA considered the Panel’s 

recommendations and, on May 30, 2008, 

published a proposed rule to reclassify 

certain PTCA catheters, including 

standard PTCA catheters for the 

treatment of in-stent restenosis and/or 

post-deployment stent expansion, but 

not cutting/scoring PTCA catheters, into 

class II. In addition, FDA issued a draft 

class II special controls guidance 

document entitled ‘‘Class II Special 

Controls Guidance Document for 

Certain Percutaneous Transluminal 

Coronary Angioplasty (PTCA) 

Catheters’’ to support the proposed 

reclassification. 

Following publication of the draft 

guidance, two sets of comments on the 

guidance were submitted to the FDA. 

The comments received sought minor 

clarifications on several pre-clinical 

testing recommendations, including 

biocompatibility, shelf-life and 

performance testing. We considered the 

suggestions and made appropriate 

revisions. In addition, the guidance was 

updated to include more specific 

recommendations regarding evaluation 

of coating integrity. FDA is now 

identifying the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document for Certain 

Percutaneous Transluminal Coronary 

Angioplasty (PTCA) Catheters’’ as the 

guidance document that will serve as 

the special control for this device type. 

The guidance document provides a 

means by which PTCA catheters, other 

than cutting/scoring PTCA catheters, 

may comply with the requirement of 

special controls for this class II device. 

Following the effective date of the final 

reclassification rule, any firm 

submitting a premarket notification 

(510(k)) for a PTCA catheter will need 

to address the issues covered in the 

special controls guidance document. 

However, the firm need only show that 

its device meets the recommendations 

of the guidance document or in some 

other way provides equivalent 

assurances of safety and effectiveness. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on standard PTCA 

catheters. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. To receive ‘‘Class II Special 

Controls Guidance Document for 

Certain Percutaneous Transluminal 

Coronary Angioplasty (PTCA) 

Catheters’’ you may either send an email request to dsmica@fda.hhs.gov to 

receive an electronic copy of the 

document or send a fax request to 301– 

847–8149 to receive a hard copy. Please 

use the document number (1608) to 

identify the guidance you are 

requesting. 

CDRH maintains an entry on the 

Internet for easy access to information 

including text, graphics, and files that 

may be downloaded to a personal 

computer with Internet access. Updated 

on a regular basis, the CDRH home page 

includes device safety alerts, Federal 

Register reprints, information on 

premarket submissions (including lists 

of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http:// 

www.regulations.gov. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 807, Subpart E, have been 

approved under OMB control number 

0910–0120; the collections of 

information in 21 CFR part 812 have 

been approved under OMB control 

number 0910–0078; the collections of 

information under CFR parts 50 and 56 

have been approved under OMB control 

number 0910–0130; the collections of 

information in 21 CFR part 820 have 

been approved under 0910–0073; and 

the collections of information in 21 CFR 

part 801 have been approved under 

OMB control number 0910–0485. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), 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: August 31, 2010. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2010–22303 Filed 9–7–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings 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: Center for Scientific 

Review Special Emphasis Panel, Selected 

Topics in Transfusion Medicine. 

Date: September 27–28, 2010. 

Time: 8 a.m. to 5 p.m. 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 173 / Wednesday, September 8, 2010 / Notices 54639 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting.) 

Contact Person: Bukhtiar H. Shah, DVM, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4120, 

MSC 7802, Bethesda, MD 20892. (301) 435– 

1233. shahb@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Member 

Conflict: Pain and Chemosensory Systems. 

Date: September 29–30, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting.) 

Contact Person: John Bishop, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5182, 

MSC 7844, Bethesda, MD 20892. (301) 408– 

9664. bishopj@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Member 

Conflict: Dermatology. 

Date: October 1, 2010. 

Time: 2 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Telephone Conference Call.) 

Contact Person: Richard Ingraham, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4116, 

MSC 7814, Bethesda, MD 20892. 301–496– 

8551. ingrahamrh@mail.nih.gov. 

Name of Committee: Emerging 

Technologies and Training Neurosciences 

Integrated Review Group, Neurotechnology 

Study Section. 

Date: October 4, 2010. 

Time: 8 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Savoy Suites, 2505 Wisconsin 

Avenue, NW., Washington, DC 20007. 

Contact Person: Robert C. Elliott, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3130, 

MSC 7850, Bethesda, MD 20892. 301–435– 

3009. elliotro@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, 

Neurotechnology 3. 

Date: October 4, 2010. 

Time: 4 p.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Savoy Suites, 2505 Wisconsin 

Avenue, NW., Washington, DC 20007. 

Contact Person: Robert C. Elliott, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3130, 

MSC 7850, Bethesda, MD 20892. 301–435– 

3009. elliotro@csr.nih.gov. 

Name of Committee: Molecular, Cellular 

and Developmental Neuroscience Integrated 

Review Group, Molecular 

Neuropharmacology and Signaling Study 

Section. 

Date: October 7–8, 2010. 

Time: 8 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Melrose Hotel, 2430 Pennsylvania 

Avenue, NW., Washington, DC 20037. 

Contact Person: Deborah L. Lewis, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4183, 

MSC 7850, Bethesda, MD 20892. 301–408– 

9129. lewisdeb@csr.nih.gov. 

Name of Committee: Emerging 

Technologies and Training Neurosciences 

Integrated Review Group, Molecular 

Neurogenetics Study Section. 

Date: October 7–8, 2010. 

Time: 8 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: St. Gregory Hotel, 2033 M Street, 

NW., Washington, DC 20036. 

Contact Person: Paek-Gyu Lee, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5203, 

MSC 7812, Bethesda, MD 20892. (301) 435– 

0902. leepg@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, 

Neurotechnology Overflow. 

Date: October 12–13, 2010. 

Time: 8 a.m. to 12 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Savoy Suites, 2505 Wisconsin 

Avenue, NW., Washington, DC 20007. 

Contact Person: Robert C. Elliott, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5190, 

MSC 7846, Bethesda, MD 20892. 301–435– 

3009. elliotro@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Shared 

Instrumentation: Neurotechnology. 

Date: October 13, 2010. 

Time: 12 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Savoy Suites, 2505 Wisconsin 

Avenue, NW., Washington, DC 20007. 

Contact Person: Robert C. Elliott, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3130, 

MSC 7850, Bethesda, MD 20892. 301–435– 

3009. elliotro@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Social 

Science and Population Studies: R03s, R15s, 

and R21s. 

Date: October 14, 2010. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Doubletree Guest Suites Santa 

Monica, 1707 Fourth Street, Santa Monica, 

CA 90401. 

Contact Person: Suzanne Ryan, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3139, 

MSC 7770, Bethesda, MD 20892. (301) 435– 

1712. ryansj@csr.nih.gov. 

Name of Committee: Biological Chemistry 

and Macromolecular Biophysics Integrated 

Review Group, Macromolecular Structure 

and Function E Study Section. 

Date: October 14, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Washington Plaza Hotel, 10 Thomas 

Circle, NW., Washington, DC 20005. 

Contact Person: Nitsa Rosenzweig, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 1102, 

MSC 7760, Bethesda, MD 20892. (301) 435– 

1747. rosenzweign@csr.nih.gov. 

Name of Committee: Cardiovascular and 

Respiratory Sciences Integrated Review 

Group, Cardiovascular Differentiation and 

Development Study Section. 

Date: October 14–15, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Churchill Hotel, 1914 Connecticut 

Avenue, NW., Washington, DC 20009. 

Contact Person: Maqsood A Wani, PhD, 

DVM, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4136, 

MSC 7814, Bethesda, MD 20892. 301–435– 

2270. wanimaqs@csr.nih.gov. 

Name of Committee: Immunology 

Integrated Review Group, Innate Immunity 

and Inflammation Study Section. 

Date: October 14–15, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Old Town Alexandria, 1767 

King Street, Alexandria, VA 22314. 

Contact Person: Tina McIntyre, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4202, 

MSC 7812, Bethesda, MD 20892. 301–594– 

6375. mcintyrt@csr.nih.gov. 

Name of Committee: Brain Disorders and 

Clinical Neuroscience Integrated Review 

Group, Acute Neural Injury and Epilepsy 

Study Section. 

Date: October 14–15, 2010. 

Time: 8 a.m. to 2:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Washington Plaza Hotel, 10 Thomas 

Circle, NW., Washington, DC 20005. 

Contact Person: Seetha Bhagavan, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5194, 

MSC 7846, Bethesda, MD 20892. (301) 237– 

9838. bhagavas@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, 

Development Methods of In Vivo Imaging 

and Bioengineering Research. 

Date: October 14–15, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 


jlentini on DSKJ8SOYB1PROD with NOTICES
54640 Federal Register / Vol. 75, No. 173 / Wednesday, September 8, 2010 / Notices 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road, NW., 

Washington, DC 20015. 

Contact Person: Behrouz Shabestari, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5106, 

MSC 7854, Bethesda, MD 20892. (301) 435– 

2409. shabestb@csr.nih.gov. 

Name of Committee: Oncology 1—Basic 

Translational Integrated Review Group, 

Molecular Oncogenesis Study Section. 

Date: October 14–15, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Crowne Plaza Old Town Alexandria, 

901 North Fairfax Street, Alexandria, VA 

22314. 

Contact Person: Nywana Sizemore, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6204, 

MSC 7804, Bethesda, MD 20892. 301–435– 

1718. sizemoren@csr.nih.gov. 

Name of Committee: Cell Biology 

Integrated Review Group, Nuclear and 

Cytoplasmic Structure/Function and 

Dynamics Study Section. 

Date: October 14–15, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The St. Regis Washington, DC, 923 

16th and K Streets, NW., Washington, DC 

20006. 

Contact Person: David Balasundaram, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5189, 

MSC 7840, Bethesda, MD 20892. 301–435– 

1022. balasundaramd@csr.nih.gov. 

Name of Committee: Infectious Diseases 

and Microbiology Integrated Review Group, 

Pathogenic Eukaryotes Study Section. 

Date: October 14–15, 2010. 

Time: 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road, NW., 

Washington, DC 20015. 

Contact Person: Tera Bounds, DVM, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3198, 

MSC 7808, Bethesda, MD 20892. 301–435– 

2306. boundst@csr.nih.gov. 

Name of Committee: Biology of 

Development and Aging Integrated Review 

Group, International and Cooperative 

Projects—1 Study Section. 

Date: October 14, 2010. 

Time: 8:30 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hotel Nikko San Francisco, 222 

Mason Street, San Francisco, CA 94102. 

Contact Person: Dan D. Gerendasy, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5132, 

MSC 7843, Bethesda, MD 20892. 301–594– 

6830. gerendad@csr.nih.gov. 

Name of Committee: Immunology 

Integrated Review Group, Immunity and Host 

Defense Study Section. 

Date: October 14–15, 2010. 

Time: 8:30 a.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Old Town Alexandria, 1767 

King Street, Alexandria, VA 22314. 

Contact Person: Patrick K. Lai, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2215, 

MSC 7812, Bethesda, MD 20892. 301–435– 

1052. laip@csr.nih.gov. 

Name of Committee: Genes, Genomes, and 

Genetics Integrated Review Group, 

Therapeutic Approaches to Genetic Diseases. 

Date: October 14, 2010. 

Time: 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Melrose Hotel, 2430 Pennsylvania 

Avenue, NW., Washington, DC 20037. 

Contact Person: Michael K. Schmidt, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2214, 

MSC 7890, Bethesda, MD 20892. (301) 435– 

1147. mschmidt@mail.nih.gov. 

Name of Committee: Immunology 

Integrated Review Group, Cellular and 

Molecular Immunology—B Study Section. 

Date: October 14–15, 2010. 

Time: 8:30 a.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Courtyard Magnificent Mile 

Downtown Chicago, 165 E. Ontario Street, 

Chicago, IL 60611. 

Contact Person: Betty Hayden, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4206, 

MSC 7812, Bethesda, MD 20892. 301–435– 

1223. haydenb@csr.nih.gov. 

Name of Committee: Genes, Genomes, and 

Genetics Integrated Review Group, Genetic 

Variation and Evolution Study Section. 

Date: October 14–15, 2010. 

Time: 8:30 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The River Inn, 924 25th Street, NW., 

Washington, DC 20037. 

Contact Person: David J. Remondini, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2210, 

MSC 7890, Bethesda, MD 20892. 301–435– 

1038. remondid@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Member 

Conflict: SAT and BTSS Study Sections. 

Date: October 14, 2010. 

Time: 2 p.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting). 

Contact Person: Roberto J. Matus, MD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5108, 

MSC 7854, Bethesda, MD 20892. (301) 435– 

2204. matusr@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: September 1, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–22311 Filed 9–7–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Notice of a Meeting of a Working 

Group of the NIH Blue Ribbon Panel 

The purpose of this notice is to inform 

the public about a meeting of the NIH 

Blue Ribbon Panel to Advise on the Risk 

Assessment of the National Emerging 

Infectious Diseases Laboratories at the 

Boston University Medical Campus. The 

meeting will be held Tuesday, October 

5, 2010 at the Mainstage at Roxbury 

Community College, 1234 Columbus 

Avenue, Roxbury, MA from 

approximately 6:30 p.m. to 10 p.m. 

This public meeting is being held to 

provide an update to the community on 

the status and proposed approach of the 

risk assessment for the BUMC NEIDL. 

The meeting program will include an 

update and review of the ongoing 

supplementary risk assessment study as 

well as opportunity for oral public 

comment. In addition, at any time, 

members of the public may file written 

comments to the following address: NIH 

Blue Ribbon Panel, Office of the 

Director, National Institutes of Health, 

Mail Stop Code 7985, Bethesda, MD 

20892–7985 or by sending an e-mail to: 

nih_brp@od.nih.gov. 

An agenda and slides for the meeting 

will be posted to the NIH Blue Ribbon 

Panel Web site in advance of the 

meeting at: http://nihblueribbonpanelbumc-neidl.od.nih.gov/. For additional 

information concerning this meeting, 

contact Ms. Kelly Fennington, Senior 

Health Policy Analyst, Office of 

Biotechnology Activities, Office of 

Science Policy, Office of the Director, 

National Institutes of Health, 6705 

Rockledge Drive, Room 750, Bethesda, 

MD 20892–7985; telephone 301–496– 

9838; e-mail fennington@nih.gov. 


jlentini on DSKJ8SOYB1PROD with NOTICES