12138 Federal Register / Vol. 74, No. 54 / Monday, March 23, 2009 / Notices 

Dated: March 17, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–6481 Filed 3–20–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

[Docket No. NIH–2009–0002] 

Public Meeting on Expansion of the 

Clinical Trial Registry and Results Data 

Bank 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: With this notice, the National 

Institutes of Health (NIH) of the U.S. 

Department of Health and Human 

Services (HHS) announces a public 

meeting and requests input from 

interested parties on issues that the 

agency will consider as it develops 

regulations to expand the clinical trial 

registry and results data bank commonly 

known as ClinicalTrials.gov in 

accordance with section 801 of the Food 

and Drug Administration Amendments 

Act of 2007 (FDAAA) [Pub. L. 110–85]. 

FDAAA requires a public meeting to be 

held to provide an opportunity for input 

from interested parties with regard to 

regulations that are to be issued within 

three years of enactment of the law. The 

NIH seeks input from all interested 

parties about issues to be considered in 

the proposed rulemaking. Comments on 

these issues will inform the 

development of draft regulations, which 

will be made available for public 

comment via a separate Notice of 

Proposed Rulemaking (NPRM) that will 

be issued in the Federal Register at a 

later date. Section III of this document 

lists specific topics and questions on 

which input is sought. 

Public Meeting Date and Time: The 

public meeting will be held on Monday, 

April 20, 2009, from 9 a.m. to 5 p.m. 

Location: The public meeting will be 

held in Masur Auditorium, which is 

located on the NIH Campus, Building 

10, South Side, First Floor, 10 Center 

Drive, Bethesda, Maryland 20892. The 

NIH, like all Federal Government 

facilities, has instituted security 

measures to ensure the safety of its 

patients, employees, visitors, and 

facilities. All visitors must enter the NIH 

campus through the Gateway Center, 

which is located adjacent to the Medical 

Center Metro Station (Red Line) at the 

South Drive entrance to the campus 

from Rockville Pike/Wisconsin Avenue 

(Route 355). Security personnel will ask 

you to submit to vehicle and personal 

inspection. Visitors over 15 years of age 

must provide a form of governmentissued ID, such as a driver’s license or 

passport. Visitors under 16 years of age 

must be accompanied by an adult. 

Additional information is available 

online at http://www.nih.gov/about/ 

visitor/. 

Registration and participation: The 

NIH desires broad participation in the 

public meeting. To ensure sufficient 

seating for all participants, we request 

that you register by 5 p.m. on Monday, 

April 13, 2009. Registration may be 

accomplished online at http:// 

prsinfo.clinicaltrials.gov/publicmeeting-april09.html or by submitting 

the following information to the Contact 

Person indicated below: Name; Title; 

Business affiliation (if any); Address; 

Telephone and fax numbers; and e-mail 

address. When registering, please 

indicate whether you need any special 

accommodations (such as wheelchair 

access). Sign-language interpretation 

will be provided at the meeting. 

Registration is on a first-come, firstserved basis. Walk-in registrations will 

be accepted at the site on a spaceavailable basis. Interested parties may 

also view the meeting remotely via live 

videocast, which will be accessible on 

the Internet at http://videocast.nih.gov. 

Oral Statements at the Meeting 

Participants wishing to make an oral 

statement during the public meeting 

should make their request when they 

register and should submit a written 

statement summarizing their remarks. 

Written statements should be submitted 

to the meeting docket at http:// 

www.regulations.gov or to the Contact 

Person indicated below by 5 p.m. on 

Monday, April 13, 2009. Written 

statements should identify by number 

each discussion question addressed, and 

written statements that exceed 10 pages 

should include a one-page executive 

summary. Registered individuals will be 

notified of the approximate scheduled 

time of their remarks prior to the 

meeting. The NIH will try to 

accommodate all persons who wish to 

make a public comment at the meeting, 

including those who register at the site, 

but it may need to limit the number of 

presentations and/or the time allotted 

for each presentation. Nevertheless, the 

full text of all written statements will be 

included in the docket, which will 

remain open for submissions after the 

conclusion of the meeting. In order that 

they may be considered by the agency 

during the development of the proposed 

rule, written comments should be 

submitted to the docket by Monday, 

June 22, 2009. Instructions for 

submitting written comments are 

described in Section IV of this notice. 

Agenda and other meeting materials: 

An agenda for the public meeting will 

be posted on the meeting Web site 

http://prsinfo.clinicaltrials.gov/publicmeeting-april09.html and submitted to 

the public docket by Wednesday, April 

15, 2009. The NIH may make other 

background material available on the 

meeting Web site in advance of the 

meeting and will submit all such 

information to the public docket. 

Contact Person: Christine Ireland, 

Committee Management Officer, 

National Library of Medicine, 6705 

Rockledge Drive, Suite 301, Bethesda, 

MD 20892–7968; telephone: 301–594– 

4929; fax: 301–402–2952; e-mail: 

irelanc@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The NIH, through its National Library 

of Medicine (NLM), has maintained a 

clinical trial registry data bank, 

commonly known as ClinicalTrials.gov, 

since 2000. The registry was 

established, in part, in response to the 

Food and Drug Administration 

Modernization Act of 1997 [Pub.L. 105– 

115], and as of March 2009 it contained 

information on more than 69,000 

clinical trials conducted in more than 

160 countries. 

The Food and Drug Administration 

Amendments Act of 2007 (FDAAA) 

[Pub.L. 110–85], enacted in September 

of 2007, increases the amount and type 

of clinical trial information that is to be 

made publicly available through the 

data bank. Section 801 of the FDAAA 

requires the Director of NIH to expand 

the data bank and requires ‘‘responsible 

parties’’ (generally, trial sponsors or 

designated principal investigators) to 

submit specified registration and results 

information describing ‘‘applicable 

clinical trials’’ (as defined in FDAAA) of 

certain drugs, biological products, and 

devices. The FDAAA specifies a set of 

registration data elements to be 

submitted to the data bank and 

authorizes the Secretary to modify the 

registration data elements by regulation 

if such modification ‘‘improves and 

does not reduce’’ the clinical trial 

information submitted to 

ClinicalTrials.gov. The FDAAA also 

specifies the deadline by which 

responsible parties are to submit 

registration information (in general, 

within 21 days of enrolling the first 

patient) and establishes a requirement 


dwashington3 on PROD1PC60 with NOTICES
Federal Register / Vol. 74, No. 54 / Monday, March 23, 2009 / Notices 12139 

for updating information if there are 

changes to report. 

The FDAAA also requires the NIH to 

expand ClinicalTrials.gov to include 

information describing the results of 

certain applicable clinical trials. The 

law requires responsible parties to 

submit ‘‘basic results’’ information for 

applicable clinical trials for which the 

drugs, biological products, and devices 

under study are approved under section 

505, 515, or 520(m) of the Federal Food, 

Drug, and Cosmetic (FDC) Act, licensed 

under section 351 of the Public Health 

Service (PHS) Act, or cleared under 

section 510(k) of the FDC Act. As 

specified in the law, the information to 

be submitted consists of certain 

administrative information and two 

categories of numerical data related to 

the clinical trial: (1) A table of 

demographic and baseline 

characteristics of the patient population, 

overall and for each arm of the clinical 

trial, including the number of patients 

who dropped out of the clinical trial or 

were excluded from the analysis; and (2) 

a table of values for each of the primary 

and secondary outcome measures, for 

each arm of the trial, including the 

results of scientifically appropriate tests 

of the statistical significance of such 

outcome measures. Narrative summaries 

of the trial results are not permitted. The 

required basic results information has 

been implemented in ClinicalTrials.gov 

as four modules of tabular data that 

describe the participant flow, baseline 

characteristics of the patient population, 

outcome measures and statistical 

analysis, and adverse events. The 

FDAAA specifies that, in general, 

results must be submitted not later than 

12 months after the trial completion 

date, which is defined as the date that 

the final subject was examined or 

received an intervention for the 

purposes of final collection of data for 

the primary outcome; however, the law 

provides several options for delayed 

submission of results information (e.g., 

when seeking initial approval of a drug 

or device or seeking approval of a new 

use for the drug or device). The FDAAA 

includes provisions to ensure that 

information submitted to the data bank 

is complete and accurate and not false, 

misleading, or promotional. The NIH 

and the Food and Drug Administration 

(FDA) are instructed to conduct a pilot 

quality control project to determine the 

‘‘optimal method’’ of verifying that 

submitted results information is 

nonpromotional and not false or 

misleading in any particular way. 

The FDAAA required the NIH 

Director to modify Clinical Trials.gov to 

include the required registration 

information by December 26, 2007, and 

to accommodate the submission of 

required ‘‘basic results information’’ by 

September 27, 2008. The NIH met these 

deadlines, and, since those dates, 

registration information has been 

submitted for more than 20,000 clinical 

trials, and basic results information has 

been submitted for more than 430 

clinical trials. In addition, data 

providers may submit adverse event 

reporting information on a voluntary 

basis; reporting of adverse event 

information will become mandatory at a 

later date. 

To provide more complete results 

information and to enhance patient 

access to and understanding of the 

results of clinical trials, the FDAAA (as 

codified in 42 U.S.C. 242(j)(3)(D)) 

requires the Secretary to further expand 

the registry and results data bank by 

regulation. The regulations are to be 

promulgated within three years of the 

law’s enactment. The FDAAA specifies 

topics to be considered in developing 

the regulations and requires the 

Secretary to convene a public meeting to 

solicit input from interested parties with 

regard to the regulations. Specific 

elements that are to be considered or 

included in the rulemaking are those 

identified for discussion at the public 

meeting in Section III. 

III. Purpose and Scope of the Public 

Meeting 

This public meeting is intended to 

provide an opportunity for interested 

parties to share their perspectives on the 

issues to be considered in the 

rulemaking for the expanded registry 

and results data bank that is required by 

the FDAAA. The NIH anticipates that 

the event will be of interest to a broad 

range of stakeholders, including patients 

and human subjects; patient advocacy 

groups; manufacturers of drugs, 

biological products, and devices whose 

products are subject to registration and 

results reporting under FDAAA; 

academic medical centers; researchers, 

and other organizations that engage in 

clinical research; members of 

Institutional Review Boards; journal 

editors who publish the result of 

clinical trials; and experts in evidencebased medicine who make use of the 

results of clinical trials. The NIH 

encourages broad participation in the 

public meeting. To provide an 

additional opportunity for interested 

parties to provide input on the issues to 

be considered in the rulemaking, the 

docket will remain open for submission 

of written comments after the meeting. 

In order for the agency to consider the 

comments during development of the 

proposed rule, the comments should be 

submitted by Monday, June 22, 2009. 

III. Issues for Discussion 

In keeping with the topics to be 

considered in the rulemaking for the 

expanded registry and results data bank, 

the NIH invites comments from 

interested parties on any and all of the 

following topics and questions: 

1. Whether to require submission of 

results information for applicable 

clinical trials of drugs, biological 

products, and devices that are not 

approved under sections 505, 515, or 

520(m) of the FDC Act, licensed under 

section 351 of the PHS Act, or cleared 

under section 510(k) of the FDC Act 

(whether or not clearance, approval or 

licensure was sought). Please comment 

on issues such as the potential 

advantages and disadvantages to the 

public and public health of disclosing 

results information for trials involving 

drugs, biological products, and devices 

that are not approved, licensed, or 

cleared; the effects (if any) on the 

development of drugs, biological 

products, and devices; the reporting 

burden on data submitters; and the 

appropriate timing of submission and 

public disclosure of information, taking 

into account the certification process 

established by the FDAAA when 

approval, licensure, or clearance is 

sought for a product under study in an 

applicable clinical trial. In particular, 

consider scenarios involving trials of 

different types of unapproved products: 

(a) Applicable clinical trials of products 

for which marketing applications or 

premarket notification submissions are 

never submitted to the FDA; (b) 

applicable clinical trials of products for 

which marketing applications or 

premarket notification submissions are 

submitted, but a decision is pending; 

and (c) applicable clinical trials of 

products for which marketing 

applications or premarket notification 

submissions are submitted and the FDA 

decides not to approve, license, or clear 

the product for marketing. 

2. Whether narrative summaries of the 

clinical trial and its results can be 

included in the data bank without being 

misleading or promotional. Comment on 

issues such as the potential advantages 

and disadvantages to patients, research 

subjects, and the public of requiring 

responsible parties to submit narrative 

summaries that are written in 

nontechnical, understandable language 

for patients; the utility to the scientific 

community of requiring responsible 

parties to submit narrative summaries 

written in technical language; the 

content and structure of any such 

narratives; and procedures that could be 

established to help ensure the content is 

not misleading or promotional. 


dwashington3 on PROD1PC60 with NOTICES
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