8368 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Notices 

Estimated number of respondents 

Estimated number of responses 

per respondent 

Average burden 

hours per response 

Estimated total 

annual burden 

hours requested 

4,860 ................................................................................................................................ 1 0.33 1,620 

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. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Dr. George Nemo, 

Project Officer, NHLBI, Two Rockledge 

Center, Suite 10042, 6701 Rockledge 

Drive, Bethesda, MD 20892–7950, or 

call 301–435–0075, or E-mail your 

request to nemog@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. 

Dated: February 17, 2010. 

Dr. George Nemo, 

NHLBI Project Officer, NHLBI, National 

Institutes of Health. 

[FR Doc. 2010–3754 Filed 2–23–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0067] 

Advisory Committee for 

Pharmaceutical Science and Clinical 

Pharmacology; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Advisory 

Committee for Pharmaceutical Science 

and Clinical Pharmacology. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on March 17, 2010, from 7:30 a.m. 

to 3 p.m. 

Location: Atlanta Marriott Marquis, 

265 Peachtree Center Ave., Atlanta, GA 

30303. The hotel phone number is 404– 

521–0000. 

Addresses: Submit electronic 

comments on this document to http:// 

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. Submit a 

single copy of electronic comments or 

two paper copies of any mailed 

comments, except that individuals may 

submit one paper copy. Comments 

should be identified with the docket 

number found in brackets in the 

heading of this document. Comments 

received on or before March 8, 2010, 

will be provided to the committee 

before the meeting. Received comments 

may be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Contact Person: Yvette Waples, Center 

for Drug Evaluation and Research (HFD– 

21), Food and Drug Administration, 

5600 Fishers Lane (for express delivery, 

5630 Fishers Lane, rm. 1093), Rockville, 

MD 20857, 301–827–7001, FAX: 301– 

827–6776, e-mail: 

yvette.waples@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512539. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On March 17, 2010, the 

committee will discuss and provide 

comments on the following topics: (1) 

General scientific issues related to the 

application of pharmacogenomics in the 

early stages of drug development. 

Pharmacogenomics examines the 

genetic differences that influence a 

person’s responses, both beneficial and 

harmful, to certain drugs; (2) a new 

patient-centric clinical pharmacology 

approach to drug safety; (3) the design 

and analysis of clinical pharmacology 

studies focusing on how the renal 

function changes in the way the body 

absorbs, distributes, metabolizes, and 

excretes a drug in patients with kidney 

impairment; and (4) scientific 

considerations and recent developments 

in transporter-mediated drug 

interactions. These interactions are 

between two or more drugs that either 

inhibit or enhance the roles of 

specialized proteins known as 

‘‘transporters’’ and, in turn, the 

interactions can affect a drug’s safety 

and/or efficacy. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before March 8, 2010. Oral 

presentations from the public will be 

scheduled between approximately 9:25 

a.m. and 10 a.m., and 1:15 p.m. and 1:45 

p.m. Those desiring to make formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 


pwalker on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Notices 8369 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before March 1, 

2010. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by March 2, 2010. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Yvette 

Waples at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 18, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–3594 Filed 2–23–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

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

hereby given of a meeting of the 

Recombinant DNA Advisory Committee. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: Recombinant DNA 

Advisory Committee. 

Date: March 10–11, 2010. 

Time: March 10, 2010, 8 a.m. to 5:30 p.m. 

Agenda: The Recombinant DNA Advisory 

Committee will review and discuss selected 

human gene transfer protocols as well as 

related data management activities. 

Additionally there will be a discussion of a 

proposal to exempt the mating of certain 

biosafety level 1 transgenic rodents from the 

requirements of Section III–E–3 of the NIH 

Guidelines for Research with Recombinant 

DNA Molecules. Please check the meeting 

agenda at http://oba.od.nih.gov/rdna_rac/ 

rac_meetings.html for more information. 

Place: Hilton Washington/Rockville, 1750 

Rockville Pike, Rockville, MD 20852. 

Time: March 11, 2010, 8 a.m. to 1:30 p.m. 

Agenda: The Recombinant DNA Advisory 

Committee will review and discuss selected 

human gene transfer protocols as well as 

related data management activities. There 

will also be a discussion of the University of 

Wisconsin’s application requesting a 

determination of the appropriate 

biocontainment for the cloning of Ebola and 

Marburg cDNAs into E. coli. Please check the 

meeting agenda at http://oba.od.nih.gov/ 

rdna_rac/rac_meetings.html for more 

information. 

Place: Hilton Washington/Rockville, 1750 

Rockville Pike, Rockville, MD 20852. 

Contact Person: Laurie Lewallen, Advisory 

Committee Coordinator, Office of 

Biotechnology Activities, National Institutes 

of Health, 6705 Rockledge Drive, Room 750, 

Bethesda, MD 20892–7985, 301–496–9838, 

lewallenl@od.nih.gov. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

oba.od.nih.gov/rdna/rdna.html, where an 

agenda and any additional information for 

the meeting will be posted when available. 

OMB’s ‘‘Mandatory Information 

Requirements for Federal Assistance Program 

Announcements’’ (45 FR 39592, June 11, 

1980) requires a statement concerning the 

official government programs contained in 

the Catalog of Federal Domestic Assistance. 

Normally NIH lists in its announcements the 

number and title of affected individual 

programs for the guidance of the public. 

Because the guidance in this notice covers 

virtually every NIH and Federal research 

program in which DNA recombinant 

molecule techniques could be used, it has 

been determined not to be cost effective or 

in the public interest to attempt to list these 

programs. Such a list would likely require 

several additional pages. In addition, NIH 

could not be certain that every Federal 

program would be included as many Federal 

agencies, as well as private organizations, 

both national and international, have elected 

to follow the NIH Guidelines. In lieu of the 

individual program listing, NIH invites 

readers to direct questions to the information 

address above about whether individual 

programs listed in the Catalog of Federal 

Domestic Assistance are affected. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.14, Intramural Research 

Training Award; 93.22, Clinical Research 

Loan Repayment Program for Individuals 

from Disadvantaged Backgrounds; 93.232, 

Loan Repayment Program for Research 

Generally; 93.39, Academic Research 

Enhancement Award; 93.936, NIH Acquired 

Immunodeficiency Syndrome Research Loan 

Repayment Program; 93.187, Undergraduate 

Scholarship Program for Individuals from 

Disadvantaged Backgrounds, National 

Institutes of Health, HHS) 

Dated: February 17, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–3585 Filed 2–23–10; 8:45 am] 

BILLING CODE 4140–01–P 

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; Member 

Conflicts in Memory, Cognition and Motor 

Control. 

Date: March 2, 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 

(Virtual Meeting). 

Contact Person: Dana Jeffrey Plude, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3176, 

MSC 7848, Bethesda, MD 20892, 301–435– 

2309, pluded@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Bone, 

Muscle and Cartilage Biology. 

Date: March 8–9, 2010. 

Time: 8:30 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: Rajiv Kumar, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4122, 

MSC 7802, Bethesda, MD 20892, 301–435– 

1212, kumarra@csr.nih.gov. 


pwalker on DSK8KYBLC1PROD with NOTICES