12140 Federal Register / Vol. 74, No. 54 / Monday, March 23, 2009 / Notices 

3. What additional information, if 

any, that is written in nontechnical, 

understandable language for patients 

should be required to be submitted to 

the data bank or should be provided in 

the data bank to assist patients in 

understanding and interpreting the 

information available in the data bank. 

Please consider the types of information 

that would best assist patients and other 

members of the public in understanding 

and interpreting results information in 

the data bank, including information on 

adverse events. Comment on issues such 

as the types of information that might 

assist patients and the public in 

understanding the results of individual 

clinical trials and of clinical trials in 

general. Identify existing sources of 

explanatory information that are 

oriented toward patients and the public 

and could be included in or linked to 

the data bank. 

4. Whether to require submission of 

the full clinical trial protocol or only 

such information on the protocol as may 

be necessary to help evaluate the results 

of the trial. Comment on the value of the 

full clinical trial protocol versus partial 

information from the protocol in 

evaluating the results of a trial and the 

completeness of results data 

submission. 

5. Procedures the agency might 

consider for quality control, with 

respect to completeness and content of 

clinical trial information, to help ensure 

that data elements are not false or 

misleading and are nonpromotional. 

Consider the effect of different 

approaches on the workload of both 

data submitters and the agency and on 

the quality of data available to the 

public, as well as suitable means for the 

agency to communicate information 

about its quality assurance processes to 

data submitters and the public. 

6. Whether the 1-year period for 

submission of basic results information 

should be increased to a period not to 

exceed 18 months. Comment on the 

advantages and disadvantages of 

increasing the period for submission of 

clinical trial information from 1-year 

after the completion date to a period not 

to exceed 18 months. Consider the 

implications for all stakeholders, 

including governmental bodies, data 

submitters, and users of 

ClinicalTrials.gov; the extent to which 

such a change would affect public 

health or the utility of the data bank; the 

possible effect on the number of 

requests that responsible parties would 

submit to the NIH requesting an 

extension of the results reporting 

deadline; and the possible 

improvements to the quality and or 

completeness of initial submissions of 

results data to the NIH. Consider the 

implications of delay periods of 

different lengths between 12 and 18 

months. 

7. Whether the clinical trial 

information required by the regulation 

should be required to be submitted for 

applicable clinical trials for which 

‘‘basic results’’ information is submitted 

before the effective date of the 

regulation. Consider the advantages and 

disadvantages to data submitters and 

users of the data bank, including 

patients, prospective human subjects, 

care providers, and researchers. 

8. The appropriate timing and 

requirements for updates of clinical trial 

information and procedures for tracking 

such updates. Please comment on the 

advantages and disadvantages of 

requiring more frequent updating of 

information submitted to the clinical 

trial registry and results data bank, 

which elements (if any) would benefit 

from more frequent updating, and what 

would be the optimal frequency of such 

updates. 

9. The standard format for the 

submission of clinical trial information 

required by the regulation, including 

adverse event information, and 

additions or modifications to the 

manner of reporting of the data elements 

established under the basic results 

reporting provisions of the FDAAA. 

10. A statement to accompany the 

entry for an applicable clinical trial 

when the primary and secondary 

outcome measures for such clinical trial 

are submitted as a ‘‘voluntary 

submission’’ after the date specified in 

the FDAAA for submission of such 

information. 

11. Other issues associated with 

Section 801 of the FDAAA that will 

inform rulemaking. 

IV. Request for Comments 

As described previously in this 

Notice, participants wishing to make an 

oral statement at the Public Meeting are 

requested to notify the NIH and to 

submit to the meeting docket or the 

Contact Person a written version of their 

remarks on the topics identified in 

Section IV by 5 p.m. on Monday, April 

13, 2009. The docket will remain open 

after the meeting, and, regardless of 

attendance at the public meeting, 

interested persons may submit written 

or electronic comments to the docket so 

that they may be considered by the 

agency during the subsequent 

rulemaking. To ensure consideration, 

written comments should be submitted 

to the docket by Monday, June 22, 2009. 

Submit electronic comments to Docket 

No. NIH–2009–0002 at http:// 

www.regulations.gov. The site contains 

instructions for submitting comments. 

V. Transcripts 

A transcript of the public meeting will 

be submitted to the docket and posted 

to http://prsinfo.clinicaltrials.gov/ 

public-meeting-april09.html 

approximately 15 working days after the 

public meeting. 

Dated: March 16, 2009. 

Raynard S. Kington, 

Acting Director, National Institutes of Health. 

[FR Doc. E9–6198 Filed 3–20–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of a meeting of the 

National Advisory Allergy and 

Infectious Diseases Council. 

The meeting will be open to the 

public. Individuals who wish to listen 

to the meeting should register with 

Jemma Long at the phone number of the 

contact person listed below at least two 

days in advance of the meeting. 

Name of Committee: National Advisory 

Allergy and Infectious Diseases Council; 

Allergy, Immunology and Transplantation 

Subcommittee. 

Date: March 31, 2009. 

Time: 1 p.m. to 1:30 p.m. 

Agenda: The subcommittee will be 

discussing a concept clearance for the 

Human Immunology Profiling Centers of 

Excellence (U01/U19). 

Place: National Institutes of Health, 6610 

Rockledge Drive, Bethesda, MD 20817 

(Telephone Conference Call). 

Contact Person: Daniel Rotrosen, PhD, 

Director, Division of Allergy, Immunology & 

Transplantation, National Institutes of 

Health/NIAID, 6610 Rockledge Drive, MSC 

6601, Bethesda, MD 20892–6601, 301–496– 

1886, drotrosen@niaid.nih.gov. 

This notice is being published less than 15 

days prior to the meeting date due to timing 

limitations created by the Economic 

Recovery Act. 

Information is also available on the 

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

www.niaid.nih.gov/facts/facts.htm, where an 

agenda and any additional information for 

the meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 


dwashington3 on PROD1PC60 with NOTICES
Federal Register / Vol. 74, No. 54 / Monday, March 23, 2009 / Notices 12141 

Dated: March 16, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–6199 Filed 3–20–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; 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 Cancer 

Institute Special Emphasis Panel; ‘‘Improved 

Effectiveness of Smoking Cessation 

Interventions and Programs in Low Income 

Adult Populations’’. 

Date: April 2–3, 2009. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Marriott Courtyard Gaithersburg 

Washingtonian Center, 204 Boardwalk Place, 

Gaithersburg, MD. 

Contact Person: Gerald G. Lovinger, PhD, 

Scientific Review Officer, Special Review 

and Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, 6116 

Executive Blvd., Room 8101, Bethesda, MD 

20892–8329, 301–496–7987, 

lovingeg@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: March 17, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–6339 Filed 3–20–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of a meeting of the Sleep 

Disorders Research Advisory Board. 

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: Sleep Disorders 

Research Advisory Board. 

Date: April 14, 2009. 

Time: 12 p.m. to 4:30 p.m. 

Agenda: To discuss sleep research, 

education priorities, and programs. 

Place: National Institutes of Health, 

Building 45, 45 Center Drive, Natcher 

Auditorium, Bethesda, MD 20892. 

Contact Person: Michael J Twery, PhD, 

Director, National Center on Sleep Disorders 

Research, Division of Lung Diseases, National 

Heart, Lung, and Blood Institute, National 

Institutes of Health, 6701 Rockledge Drive, 

Suite 10038, Bethesda, MD 20892–7952, 301– 

435–0199, twerym@nhlbi.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

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

www.nhlbi.nih.gov/meetings/index.htm, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: March 16, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–6205 Filed 3–20–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; 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 Heart, Lung, 

and Blood Institute Special Emphasis Panel, 

Conference Grants (R13’s). 

Date: March 31–April 1, 2009. 

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: David A Wilson, PhD, 

Scientific Review Administrator, Review 

Branch/DERA, National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7204, Bethesda, MD 20892–7924, 301–435– 

0299, wilsonda2@nhlbi.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: March 16, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–6207 Filed 3–20–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 


dwashington3 on PROD1PC60 with NOTICES