9008 Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Notices 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. 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 

part 1271, subpart C have been 

approved under OMB Control No. 0910–

0543. The collections of information in 

part 1271, subpart D have been 

approved under OMB Control No. 0910–

0559. 

III. Comments 

Interested persons may, at any time, 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the 

guidance announced in this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in the brackets in 

the heading of this document. A copy of 

the guidance and received comments 

are available for public examination in 

the Division of Dockets Management 

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

through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either http:// 

www.fda.gov/cber/guidelines.htmor 

http://www.fda.gov/ohrms/dockets/ 

default.htm. 

Dated: February 21, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–3445 Filed 2–27–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0021] 

Draft Guidance for Industry on 

Advisory Committee Meetings: 

Preparation and Public Availability of 

Information Given to Advisory 

Committee Members; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Advisory Committee 

Meetings—Preparation and Public 

Availability of Information Given to 

Advisory Committee Members.’’ This 

guidance is intended to provide 

information to industry sponsors, 

applicants, and petitioners on the 

development, preparation, or 

submission of briefing materials that 

will be given to advisory committee 

members as background information 

prior to open FDA advisory committee 

meetings. The guidance will help 

sponsors develop, organize, and submit 

advisory committee briefing materials 

for public release and should help 

minimize the time and resources spent 

in preparing these materials for public 

availability. The guidance also describes 

the process FDA intends to follow when 

we make briefing materials available to 

the public. 

DATES: Submit written or electronic 

comments on the draft guidance 

document by April 30, 2007. General 

comments on agency guidance 

documents are welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to 

Office of Policy (HF–11), Office of the 

Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist the 

office in processing your request. 

Submit written comments on the draft 

guidance to Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Poppy Kendall, Food and Drug 

Administration (HF–11), 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

3360, FAX: 301–594–6777, e-mail: 

poppy.kendall@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Advisory Committee Meetings—

Preparation and Public Availability of 

Information Given to Advisory 

Committee Members.’’ This guidance 

will help sponsors develop, prepare, 

and submit advisory committee briefing 

materials and should help minimize the 

time and resources spent in preparing 

these materials for public availability. 

The guidance also describes the process 

FDA intends to follow when we make 

briefing materials available to the 

public. The term ‘‘briefing materials’’ is 

used to describe the package of 

information that we provide to advisory 

committee members before a meeting, 

and that usually contains information 

prepared by us and/or the sponsor (if 

the meeting involves an application or 

particular product). In addition, the 

Appendices to the draft guidance 

provide timelines for preparing and 

submitting briefing materials to FDA. 

For open advisory committee 

meetings for which the briefing 

materials may contain information that 

under certain circumstances could be 

considered to be exempt from disclosure 

under the Freedom of Information Act 

(FOIA) (5 U.S.C. 552), we intend to post 

the publicly available version of the 

briefing materials on our Web site at 

least 2 full business days before the 

advisory committee meeting is 

scheduled to occur. With respect to 

meetings for which the briefing 

materials do not contain information 

that could be considered exempt from 

disclosure under FOIA, we will 

probably make the briefing materials 

available on our Web site more than 2 

full business days before the advisory 

committee meeting is schedule to occur. 

In the latter case, we anticipate that 

meetings subject to this timeline will 

normally address general matters such 

as guidance documents and policy 

issues related to FDA-regulated 

products. 

This draft guidance, which will 

harmonize the preparation and public 

availability of information given to 

advisory committee members for all 

products regulated by FDA, replaces 

three previously issued draft guidances: 

(1) ‘‘Disclosing Information Provided to 

Advisory Committees in Connection 

With Open Advisory Committee 

Meetings Related to the Testing or 

Approval of New Drugs and Convened 

by the Center for Drug Evaluation and 

Research, Beginning on January 1, 

2000;’’ (2) ‘‘Disclosing Information 

Provided to Advisory Committees in 

Connection With Open Advisory 

Committee Meetings Related to the 

Testing or Approval of Biologic 

Products and Convened by the Center 

for Biologics Evaluation and Research;’’

and (3) ‘‘Availability of Information 

Given to Advisory Committee Members 

in Connection With the Center for 

Devices and Radiological Health Open 

Public Panel Meetings.’’ An important 

goal of this guidance is to help ensure 

that briefing materials are made 

available to the public as provided 

under section 10(b) of the Federal 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Notices 9009 

Advisory Committee Act (5 U.S.C. app. 

2). The guidance includes 

recommendations on how to identify 

information that is exempt from public 

disclosure under the FOIA. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent FDA’s current thinking on this 

topic. 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 the 

approach satisfies the requirements of 

the applicable statutes and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, 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. The draft 

guidance and received comments may 

be seen in the Division of Dockets 

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

Monday through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/opacom/morechoices/ 

industry/guidedc.htm. 

Dated: January 24, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–887 Filed 2–26–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities. Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, 

Public Law 104–13), the Health 

Resources and Services Administration 

(HRSA) publishes periodic summaries 

of proposed projects being developed 

for submission to the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

To request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, call the HRSA Reports 

Clearance Officer on (301) 443–1129. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the Agency, 

including whether the information shall 

have practical utility; (b) the accuracy of 

the Agency’s estimate of the burden of 

the proposed collection of information; 

(c) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Proposed Project: National Practitioner 

Data Bank for Adverse Information on 

Physicians and Other Health Care 

Practitioners: Regulations and Forms 

(OMB No. 0915–0126)—Extension 

The National Practitioner Data Bank 

(NPDB) was established through Title IV 

of Public Law (P.L.) 99–660, the Health 

Care Quality Improvement Act of 1986, 

as amended. Final regulations governing 

the NPDB are codified at 45 CFR part 

60. Responsibility for NPDB 

implementation and operation resides 

in the Bureau of Health Professions, 

Health Resources and Services 

Administration, Department of Health 

and Human Services (HHS). The NPDB 

began operation on September 1, 1990. 

The intent of Title IV of P.L. 99–660 

is to improve the quality of health care 

by encouraging hospitals, State 

licensing boards, professional societies, 

and other entities providing health care 

services, to identify and discipline those 

who engage in unprofessional behavior; 

and to restrict the ability of incompetent 

physicians, dentists, and other health 

care practitioners to move from State to 

State without disclosure of the 

practitioner’s previous damaging or 

incompetent performance. 

The NPDB acts primarily as a flagging 

system; its principal purpose is to 

facilitate comprehensive review of 

practitioners’ professional credentials 

and background. Information on 

medical malpractice payments, adverse 

licensure actions, adverse clinical 

privileging actions, adverse professional 

society actions, and Medicare/Medicaid 

exclusions is collected from, and 

disseminated to, eligible entities. It is 

intended that NPDB information should 

be considered with other relevant 

information in evaluating a 

practitioner’s credentials. 

The reporting forms and the request 

for information forms (query forms) are 

accessed, completed, and submitted to 

the NPDB electronically through the 

NPDB Web site at http://www.npdbhipdb.hrsa.gov. All reporting and 

querying is performed through this 

secure Web site. Due to overlap in 

requirements for the Healthcare 

Integrity and Protection Data Bank 

(HIPDB), some of the NPDB’s burden 

has been subsumed under the HIPDB. 

Estimates of Annualized Burden are 

as Follows: 

Regulation citation Number of 

respondents 

Frequency of 

responses 

Hours per 

response 

(minutes) 

Total burden 

hours 

60.6(a) Errors & Omissions ......................................................................... 303 5 15 385 

60.6(b) Revisions to Actions ........................................................................ 115 1 .1 30 64 

60.7(b) Medical Malpractice Payment Report ............................................. 485 39 45 14,236 

60.8(b) Adverse Action Reports—State Boards .......................................... 0 0 0 0 

60.9(a)3 Adverse Action Clinical Privileges & Professional Society ........... 686 1 .5 45 785 

Requests for Hearings by Entities ............................................................... 1 1 480 8 

60.10(a)(1) Queries by Hospital—Practitioner Applications ........................ 6,000 37 .3 5 18,615 

60.10(a)(2) Queries by Hospitals—Two Yr. Cycle ...................................... 6,000 149 5 74,461 

60.11(a)(1) Disclosure to Hospitals ............................................................. 0 0 0 0 

60.11(a)(2) Disclosure to Practitioners (Self-Query) ................................... 0 0 0 0 

60.11(a)(3) Disclosure to Licensure Boards ................................................ 80 225 5 1,499 

60.11(a)(4) Queries by Non-Hospital Health Care Entities ......................... 4,938 437 5 179,673 

60.11(a)(5) Queries by Plaintiffs’ Attorneys ................................................ 5 5 30 3 .0 

60.11(a)(6) Queries by Non-Hospital Health Care Entities—Peer Review 0 0 0 0 


sroberts on PROD1PC70 with NOTICES