Federal Register / Vol. 72, No. 183 / Friday, September 21, 2007 / Notices 54045 

conducted. Minutes shall be kept and 

shall include the numerical results of 

votes on protocols involving use in 

human subjects. Under § 361.1(c)(3), 

each Radioactive Drug Research 

Committee shall submit an annual 

report to FDA. The annual report shall 

include the names and qualifications of 

the members of, and of any consultants 

used by, the Radioactive Drug Research 

Committee, using FDA Form 2914, and 

a summary of each study conducted 

during the proceeding year, using FDA 

Form 2915. 

Under § 361.1(d)(5), each investigator 

shall obtain the proper consent required 

under the regulations. Each female 

research subject of childbearing 

potential must state in writing that she 

is not pregnant, or on the basis of a 

pregnancy test be confirmed as not 

pregnant. 

Under § 361.1(d)(8), the investigator 

shall immediately report to the 

Radioactive Drug Research Committee 

all adverse effects associated with use of 

the drug, and the committee shall then 

report to FDA all adverse reactions 

probably attributed to the use of the 

radioactive drug. 

Section 361.1(f) sets forth labeling 

requirements for radioactive drugs. 

These requirements are not in the 

reporting burden estimate because they 

are information supplied by the Federal 

Government to the recipient for the 

purposes of disclosure to the public (5 

CFR 1320.3(c)(2)). 

Types of research studies not 

permitted under this regulation are also 

specified, and include those intended 

for immediate therapeutic, diagnostic, 

or similar purposes or to determine the 

safety or effectiveness of the drug in 

humans for such purposes (i.e., to carry 

out a clinical trial for safety or efficacy). 

These studies require filing of an 

investigational new drug application 

(IND) under 21 CFR part 312, and the 

associated information collections are 

covered in OMB control no. 0910–0014. 

The primary purpose of this 

collection of information is to determine 

if the research studies are being 

conducted in accordance with required 

regulations and that human subject 

safety is assured. If these studies were 

not reviewed, human subjects could be 

subjected to inappropriate radiation or 

pharmacologic risks. 

Respondents to this information 

collection are the chairperson(s) of each 

individual Radioactive Drug Research 

Committee, investigators, and 

participants in the studies. 

The burden estimates are based on 

FDA’s experience with these reporting 

and recordkeeping requirements over 

the past few years and the number of 

submissions received by FDA under the 

regulations. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR 

Section Forms No. of Respondents 

No. of Responses 

per Respondent 

Total Annual 

Responses 

Hours per 

Response Total Hours 

361.1(c)(3) 

and (c)(4) FDA 2914 80 1 80 1 80 

361.1(c)(3) FDA 2915 50 6.8 340 3.5 1,190 

361.1(d)(8) 50 6.8 340 0.1 34 

Total Reporting 1,304 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

of Recordkeeping 

Hours per 

Record Total Hours 

361.1(c)(2) 80 4 10 800 

361.1(d)(5) 50 6.8 .75 38 

Total Recordkeeping 838 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: September 14, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–18646 Filed 9–20–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0347] 

Information Technology Strategic 

Planning; Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

Request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting to solicit views and 

information from interested persons on 

issues concerning how the agency can 

best plan and apply information 

technology (IT) resources to support the 

process for the review of human drug 

applications. In particular, FDA is 

seeking views and information from 

interested persons to identify and 

prioritize IT solutions that will support 

the process for the review of human 

drug applications. To help solicit such 

information and views, FDA is seeking 

responses to specific questions (see 

section IV of this document). 

DATES: Public Meeting: The public 

meeting will be held on October 19, 

mstockstill on PROD1PC66 with NOTICES

54046 Federal Register / Vol. 72, No. 183 / Friday, September 21, 2007 / Notices 

2007, from 9 a.m. to 5 p.m. However, 

depending on the level of public 

participation, the meeting may be 

extended or may end early. 

Registration and Participation: 

Registration on the day of the public 

meeting will be provided on a space 

available basis beginning at 7:30 a.m. 

Because seating is limited, we 

recommend arriving early. See section I 

of the SUPPLEMENTARY INFORMATION

section of this document for information 

on how to participate in the meeting. If 

you need special accommodations due 

to a disability, please contact Carolyn 

Yancey (see FOR FURTHER INFORMATION

CONTACT) at least 7 days in advance of 

the meeting. 

Comments: Submit written or 

electronic notices of participation and 

comments by 2 weeks prior to the 

public meeting. The docket for this 

meeting will remain open to receive 

additional comments until 15 days after 

the meeting date. 

ADDRESSES: The public meeting will be 

held at the Advisors and Consultants 

Staff Conference Room, FDA, 5630 

Fishers Lane, Rockville, MD 20857. 

Additional information on parking and 

public transportation may be accessed at 

http://www.fda.gov/oc/pdufa/ 

default.htm. 

Submit written notices of 

participation and comments to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20857. Submit electronic notices of 

participation and comments to http:// 

www.accessdata.fda.gov/scripts/oc/ 

dockets/comments/commentdocket.cfm. 

Identify all submissions to the docket 

with the docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Carolyn Yancey, Office of Chief 

Information Officer (HFA–80), Food and 

Drug Administration, 5600 Fishers 

Lane, Rm. 16B–45, Rockville, MD 

20857, 301–827–4302, 

carolyn.yancey@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. How to Participate in the Meeting 

If you wish to make an oral 

presentation during the meeting, you 

must submit a written notice of 

participation with the Division of 

Dockets Management (see ADDRESSES) 

no later than 2 weeks prior to the public 

meeting (see DATES). To ensure timely 

handling, any outer envelope should be 

clearly marked with the docket number 

found in brackets in the heading of this 

document, along with the statement 

‘‘Electronic Submission of Regulatory 

Information, and Creating an Electronic 

Platform for Enhanced Information 

Management.’’ In the written notice, 

submit presenter’s name and title, 

address, telephone and fax number, email address, affiliation (if any), the 

sponsor of the presentation (e.g., the 

organization paying travel expenses or 

fees) (if any), and a brief summary of the 

presentation (including the discussion 

topic(s) that will be addressed or other 

pertinent information related to the 

topic in your presentation). If there are 

multiple participants please include the 

names and addresses of all individuals 

that plan to participate, and the 

approximate time requested for your 

presentation. We encourage individuals 

and organizations with common 

interests to consolidate or coordinate 

their presentations to allow adequate 

time for each request for presentation. 

Participants should submit to the 

Division of Dockets Management two 

copies of each presentation. We will file 

the meeting schedule indicating the 

order of presentation and the time 

allotted to each person with the 

Division of Dockets Management (see 

ADDRESSES). We will also mail or 

telephone the schedule to each 

participant before the meeting. In 

anticipation of the meeting 

presentations moving ahead of 

schedule, participants are encouraged to 

arrive early to ensure their designated 

order of presentation. Participants who 

are not present when called risk 

forfeiting their scheduled time. 

II. Background 

Over the years, FDA has agreed to 

several IT-related performance 

commitments, starting with computer 

assisted reviews in the Prescription 

Drug User Fee Act (PDUFA) I, and 

continuing with the PDUFA III 

Electronic Applications and Submission 

Goals in which FDA committed to 

implementing the electronic Common 

Technical Document (eCTD) and a 

common solution for the secure 

exchange of content, including secure email and electronic submissions. FDA 

met these commitments by 

implementing the Electronic 

Submissions Gateway at http:// 

www.fda.gov/esg/ and an electronic 

system for facilitating the receipt and 

review of submissions in the eCTD 

format (http://www.fda.gov/cder/ 

regulatory/ersr/ectd.htm). In addition, 

FDA implemented the first phase of the 

electronic labeling rule in the Center for 

Drug Evaluation and Research at http:// 

www.fda.gov/oc/datacouncil/spl.html. 

Simultaneously, the Federal 

Government has also been pursuing 

healthcare electronic standards. In 2004, 

the President issued Executive Order 

13335 establishing the position of the 

National Coordinator for Health 

Information Technology within the 

Office of the Secretary of Health and 

Human Services (HHS). The primary 

purpose of this position is to aid the 

Secretary of HHS in achieving the 

President’s goal for most Americans to 

have access to an interoperable 

electronic medical record by 2014. One 

of the key initiatives under the Office of 

the National Coordinator was the 

establishment of the Health Information 

Technology Standards Panel—a publicprivate partnership with broad 

participation across more than 300 

health-related organizations—to identify 

and harmonize data and technical 

standards for healthcare. Adding to the 

complexity of the healthcare movement 

towards a standards-based approach is 

the impact this may have on the 

regulated entities, from the small startup 

companies and research organizations, 

to the large multinational companies 

who submit regulatory submissions 

globally and are requesting global 

coordination on healthcare standards. 

During this timeframe FDA published 

IT plans to communicate FDA’s overall 

direction and strategy in meeting ITrelated performance goals and to 

describe our efforts in moving towards 

an electronic submission and review 

environment. In producing the previous 

IT plans FDA developed the plans 

internally and published the plans on 

the web—for example at http:// 

www.fda.gov/oc/pdufa/default.htm. As 

FDA moves towards an automated 

standards-based electronic review 

environment, the agency is seeking 

public input on the type of information 

to be included in future IT plans that 

will provide our external stakeholders 

the information needed to be in 

alignment with the program direction 

and goals. 

III. Purpose and Scope of the Meeting 

The purpose of this public meeting is 

to provide stakeholders the opportunity 

to address specific topics (see section IV 

of this document) and present their 

views, recommendations, and any other 

pertinent information related to the 

scope of this public meeting. The scope 

of this public meeting includes the 

following areas: 

1. The content of IT plans that is most 

useful to external stakeholders, 

2. The data standards and guidance 

that best support available IT 

capabilities and any implementation 

considerations, and 

3. How agency architecture and IT 

solutions can best be applied to support 

public health mission needs. 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 72, No. 183 / Friday, September 21, 2007 / Notices 54047 

IV. Issues for Discussion 

We are specifically interested in 

hearing comments regarding the 

following questions and any other 

pertinent information related to the 

feasibility of the electronic submission 

of premarket applications and other 

regulatory information related to the 

review of human drug applications 

including postmarket data sources: 

1. What would help improve the 

quality of electronic submissions to the 

agency? 

2. What would help increase the 

quantity of electronic submissions to the 

agency? 

3. How would you prioritize these 

quality and quantity improvements? 

4. What data standards are needed to 

implement these improvements? 

5. How should FDA engage 

stakeholders while developing, testing, 

and implementing these solutions? 

6. What topics are most useful to 

include in IT plans? 

7. What lead time is needed for 

stakeholders to respond to and be in 

alignment with FDA initiatives? 

8. How should FDA coordinate with 

stakeholders on the adoption and 

implementation of data standards? 

9. What data standards areas provide 

the greatest challenge? 

10. What approaches will facilitate 

the most effective and efficient adoption 

and implementation of data standards? 

11. What key areas require new or 

expanded electronic submissions 

guidance? 

12. What lessons learned and best 

practices should FDA consider as we 

transition from program-specific to 

enterprise IT solutions using a reusable 

and modular model? 

13. What specific concerns (i.e., 

security, confidentiality, etc.) exist for a 

third party entity or entities providing 

services related to electronic 

submissions and review and how can 

they be addressed? 

V. Notice of Public Meeting 

The Commissioner of Food and Drugs 

is announcing that the public meeting 

will be conducted by FDA senior 

management. Persons who wish to 

participate in the meeting must file a 

written or electronic notice of 

participation with the Division of 

Dockets Management (see ADDRESSES

and DATES). No participant may 

interrupt the presentation of another 

participant. Only the presiding officer 

and panel members may question any 

person during or at the conclusion of 

each presentation. Under 21 CFR 

10.205, representatives of the electronic 

media may be permitted, subject to 

certain limitations, to videotape, film, or 

otherwise record FDA’s public 

administrative proceedings, including 

presentations by participants. 

VI. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic notices 

of participation and comments for 

consideration. To permit time for all 

interested persons to submit data, 

information, or views on this subject, 

the administrative record of the meeting 

will remain open until 2 weeks prior to 

the public meeting. Persons who wish to 

provide additional materials for 

consideration should file these materials 

with the Division of Dockets 

Management (see ADDRESSES). You 

should annotate and organize your 

comments to identify the specific 

questions to which they refer (see 

section IV of this document). Two paper 

copies of any mailed comments are to be 

submitted, except that individuals may 

submit one paper copy. Comments are 

to be identified with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in Division of Dockets Management 

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

through Friday. 

VII. Transcripts 

The meeting will be transcribed. 

Transcripts of the meeting will be 

available for review at the Division of 

Dockets Management (see ADDRESSES) 

and on the Internet at http:// 

www.fda.gov/ohrms/dockets 

approximately 21 days after the 

meeting. You may place orders for 

copies of the transcript through the 

Freedom of Information Office (HFI–35), 

Food and Drug Administration, 5600 

Fishers Lane, Rm. 6–30, Rockville, MD 

20857, at a cost of 10 cents per page. 

Dated: September 17, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–4692 Filed 9–18–07; 12:12 pm] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Research 

Resources; Notice of Closed Meetings 

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 

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: National Center for 

Research Resources Special Emphasis Panel, 

Florida International University Site Visit. 

Date: October 18–19, 2007. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Park Plaza Hotel, 415 North Monroe 

Street, Tallahassee, FL 32301. 

Contact Person: Guo Zhang, PhD, MD, 

Scientific Review Administrator, National 

Center for Research Resources, or National 

Institutes of Health, 6701 Democracy 

Boulevard, 1 Democracy Plaza, Room 1064, 

MSC 4874, Bethesda, MD 20892–4874, 301–

435–0812, zhanggu@mail.nih.gov. 

Name of Committee: National Center for 

Research Resources Special Emphasis Panel, 

Tulane NPRC. 

Date: October 29–31, 2007. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Wyndham New Orleans, 100 Rue 

Iberville, New Orleans, LA 70130. 

Contact Person: Carol Lambert, PhD, 

Scientific Review Administrator, Office of 

Review, National Center for Research 

Resources, National Institutes of Health, 6701 

Democracy Blvd., 1 Dem. Plaza, Room 1076, 

Bethesda, MD 20892, 301–435–0814, 

lambert@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research; 93.371, Biomedical 

Technology; 93.389, Research Infrastructure, 

93.306, 93.333, National Institutes of Health, 

HHS) 

Dated: September 14, 2007. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–4669 Filed 9–20–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

mstockstill on PROD1PC66 with NOTICES