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This draft guidance is being issued 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The draft guidance, when finalized, will 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
9010 Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Notices 

Regulation citation Number of 

respondents 

Frequency of 

responses 

Hours per 

response 

(minutes) 

Total burden 

hours 

60.11(a)(7) Requests by Researchers for Aggregated Data ...................... 100 1 30 50 

60.14(b) Practitioner Places a Report in Disputed Status .......................... 666 1 5 55 

60.14(b) Practitioner Statement ................................................................... 2,563 1 45 1,922 

60.14(b) Practitioner Requests for Secretarial Review ............................... 117 1 480 936 

60.3 Entity Registration—Initial ................................................................... 500 1 60 500 

60.3 Entity Registration—Update ................................................................ 643 1 5 54 

60.11(a) Authorized Agent Designation—Initial .......................................... 500 1 15 125 

60.11(a) Authorized Agent-Update .............................................................. 86 1 5 7 

60.12(c) Account Discrepancy Report ......................................................... 300 1 15 75 

60.12(c) Electronic Funds Transfer Authorization ....................................... 363 1 15 91 

60.3 Entity Reactivation ............................................................................... 100 1 60 100 

Total ...................................................................................................... ........................ .......................... ........................ 293,644 

Numbers in the table may not add up exactly due to rounding. 

Send comments to Susan Queen, PhD, 

HRSA Reports Clearance Officer, Room 

10–33, Parklawn Building, 5600 Fishers 

Lane, Rockville, Maryland 20857. 

Written comments should be received 

within 60 days of this notice. 

Dated: February 22, 2007. 

Alexandra Huttinger, 

Acting Director, Division of Policy Review 

and Coordination. 

[FR Doc. E7–3446 Filed 2–27–07; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Commission on Childhood 

Vaccines; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Advisory Commission on 

Childhood Vaccines (ACCV). 

Date and Time: March 7, 2007, 1 p.m.–5 

p.m., EST. March 8, 2007, 9 a.m.–3:30 p.m., 

EST. 

Place: Audio Conference Call and 

Parklawn Building, Conference Rooms G & H, 

5600 Fishers Lane, Rockville, MD 20857. 

The ACCV will meet on Wednesday, 

March 7, from 1 p.m. to 5 p.m., and on 

Thursday, March 8, from 9 a.m. to 3:30 p.m. 

The public can join the meeting in person at 

the address listed above or by audio 

conference call by dialing 1–888–947–9967 

on March 7 and 8 and providing the 

following information: 

Leader’s Name: Dr. Geoffrey Evans. 

Password: ACCV. 

Agenda: The agenda items for the March 

meeting will include, but are not limited to: 

A discussion of VICP outreach activities; an 

overview of the Vaccine Adverse Event 

Reporting System, including the 

requirements for the reporting of adverse 

events; a report from the ACCV Futures 

Workgroup; and updates from the Division of 

Vaccine Injury Compensation (DVIC), 

Department of Justice, National Vaccine 

Program Office, Immunization Safety Office 

(Centers for Disease Control and Prevention), 

National Institute of Allergy and Infectious 

Diseases (National Institutes of Health), and 

Center for Biologics and Evaluation Research 

(Food and Drug Administration). Agenda 

items are subject to change as priorities 

dictate. 

Public Comments: Persons interested in 

providing an oral presentation should submit 

a written request, along with a copy of their 

presentation, to: Ms. Cheryl Lee, Principal 

Staff Liaison, DVIC, Healthcare Systems 

Bureau (HSB), Health Resources and Services 

Administration (HRSA), Room 11C–26, 5600 

Fishers Lane, Rockville, MD 20857 or e-mail: 

clee@hrsa.gov. Requests should contain the 

name, address, telephone number, and any 

business or professional affiliation of the 

person desiring to make an oral presentation. 

Groups having similar interests are requested 

to combine their comments and present them 

through a single representative. The 

allocation of time may be adjusted to 

accommodate the level of expressed interest. 

DVIC will notify each presenter by mail or 

telephone of their assigned presentation time. 

Persons who do not file an advance request 

for a presentation, but desire to make an oral 

statement, may announce it at the time of the 

comment period. These persons will be 

allocated time as it permits. 

For Further Information Contact: Anyone 

requiring information regarding the ACCV 

should contact Ms. Cheryl Lee, Principal 

Staff Liaison, DVIC, HSB, HRSA, Room 11C–

26, 5600 Fishers Lane, Rockville, MD 20857; 

telephone (301) 443–2124 or e-mail: 

clee@hrsa.gov. 

Notification: Due to inclement weather, the 

requirement that the public be notified of this 

meeting at least 15 calendar days in advance 

was not met. 

Dated: February 22, 2007. 

Alexandra Huttinger, 

Acting Director, Division of Policy Review 

and Coordination. 

[FR Doc. E7–3559 Filed 2–27–07; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Request for 

Genetic Studies in a Cohort of U.S. 

Radiologic Technologists 

SUMMARY: Under the provisions of 

section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Cancer Institute, the National Institutes 

of Health (NIH) has submitted to the 

Office of Management and Budget 

(OMB) a request to review and approve 

the information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on December 29, 2006, pages 

78445–78446 and allowed 60 days for 

public comment. No public comments 

were received. The purpose of this 

notice is to allow an additional 30 days 

for public comment. The National 

Institutes of Health may not conduct or 

sponsor, and the respondent is not 

required to respond to, an information 

collection that has been extended, 

revised, or implemented on or after 

October 1, 1995, unless it displays a 

currently valid OMB control number. 

Proposed Collection 

Title: Genetic Studies in a Cohort of 

U.S. Radiologic Technologists (formerly 

known as ‘‘Generic Clearance to Collect 

Medical Outcome and Risk Factor Data 

from a Cohort of U.S. Radiologic 

Technologists’’). Type of Information 

Collection Request: Renewal with 

change of a previously approved 

collection (OMB No. 0925–0405, 

expiration 02/28/2007). Need and Use 

of Information Collection: The primary 

aim of this collection is to substantially 

increase knowledge about the possible 

modifying role of genetic variation on 

the long-term health effects associated 

with protracted low-to moderate-dose 


sroberts on PROD1PC70 with NOTICES