10224 Federal Register / Vol. 72, No. 44 / Wednesday, March 7, 2007 / Notices 

Dated: February 27, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–3915 Filed 3–6–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0062] 

Guidance on Drug Safety 

Information—Food and Drug 

Administration’s Communication to 

the Public; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance titled ‘‘Drug 

Safety Information—FDA’s 

Communication to the Public.’’ This 

guidance describes FDA’s current 

approach to communicating important 

drug safety information, including 

emerging drug safety information, to the 

public and the factors that influence 

when such information is 

communicated. This guidance was 

developed in connection with FDA’s 

Drug Safety Initiative. This guidance is 

the final version and supersedes the 

previously issued draft guidance titled 

‘‘FDA’s Drug Watch for Emerging Drug 

Safety Information’’ (70 FR 24606, May 

10, 2005). 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

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

office in processing your requests. 

Submit written comments on the 

guidance to the 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 guidance 

document. 

FOR FURTHER INFORMATION CONTACT: Paul 

J. Seligman, Associate Director for 

Safety Policy and Communication, 

Center for Drug Evaluation and Research 

(HFD–001), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–443–5570. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance entitled ‘‘Drug Safety 

Information—FDA’s Communication to 

the Public.’’ This guidance describes 

FDA’s current approach to 

communicating important drug safety 

information, including emerging drug 

safety information, to the public and the 

factors that influence when such 

information is communicated. 

For many years, FDA has provided 

information on drug risks and benefits 

to healthcare professionals and patients 

when that information has generated a 

specific concern or prompted a 

regulatory action, such as a revision to 

the drug product’s labeling. FDA has 

been reexamining its risk 

communication program, including how 

and when we communicate emerging 

drug safety information to the public. 

More recently, FDA has begun taking a 

more comprehensive approach to 

making information on potential drug 

risks available to the public earlier, in 

some cases while the agency still is 

evaluating whether any regulatory 

action is warranted. FDA believes that 

timely communication of important 

drug safety information will give 

healthcare professionals, patients, 

consumers, and other interested persons 

access to the most current information 

concerning the potential risks and 

benefits of a marketed drug, helping 

them to make more informed individual 

treatment choices. 

FDA’s risk communication efforts are 

part of a larger drug safety initiative that 

began in November 2004, when FDA 

announced an initiative to strengthen 

the safety program for marketed drugs. 

This initiative included the following: 

(1) Sponsoring an independent study by 

the Institute of Medicine of the National 

Academies of the effectiveness of the 

drug safety system, with emphasis on 

postmarketing risk assessment and 

surveillance; (2) conducting workshops 

and Advisory Committee meetings 

regarding complex drug safety and risk 

management issues, including emerging 

concerns; and (3) publishing three risk 

management guidances. FDA 

augmented its drug safety initiative in 

February 2005 by creating an 

independent Drug Safety Oversight 

Board to enhance oversight of drug 

safety decision making within the 

Center for Drug Evaluation and Research 

(CDER). 

In May 2005, FDA issued a draft 

guidance titled ‘‘FDA’s Drug Watch for 

Emerging Drug Safety Information’’ (70 

FR 24606, May 10, 2005). The draft 

guidance described a proposal to 

establish a new communication 

channel, called the ‘‘Drug Watch’’ Web 

page, to provide information to the 

public on emerging drug safety issues. 

In December 2005, FDA held a public 

hearing regarding ‘‘FDA’s 

Communication of Drug Safety 

Information’’ that examined the various 

risk communication tools employed by 

FDA. FDA has carefully reviewed the 

comments it received on the draft 

guidance (30 comments were submitted 

to the public docket) and during the 

public hearing. This final version of the 

guidance reflects our consideration of 

these comments, as well as our 

experience with posting emerging drug 

safety information. 

Due to potential confusion between 

the proposed ‘‘Drug Watch’’ and FDA’s 

existing ‘‘MedWatch’’ program, FDA no 

longer plans to use the name ‘‘Drug 

Watch’’ to describe the Web page that 

contains drug safety information. We 

have identified drugs that have been the 

subject of a Public Health Advisory or 

an Alert on a single Web page, the Index 

to Drug-Specific Information, linked 

from FDA’s Web site. This is part of our 

ongoing effort to use and enhance 

existing FDA communications 

mechanisms to better convey important 

drug safety information to the public. In 

addition, we have revised this guidance 

to describe the various methods FDA 

currently uses to communicate 

established and emerging drug safety 

information to the public. It should be 

noted that we will continue to evaluate 

and enhance the effectiveness of the 

various methods we use to 

communicate about important drug 

safety issues, including the mechanisms 

described in this guidance and the 

presentation of drug safety information 

on the Agency Web sites (http:// 

www.fda.gov and http://www.fda.gov/ 

cder). We intend to update this 

guidance, as appropriate, to reflect any 

substantial modifications to our 

communication of drug safety 

information to the public. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’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. 

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 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 44 / Wednesday, March 7, 2007 / Notices 10225 

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. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. 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 

21 CFR 310.305, 314.80, 314.98, and 

600.80 have been approved under OMB 

control numbers 0910–0230, 0910–0291, 

and 0910–0308. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: February 28, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–1048 Filed 2–2–07; 10:22 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, Pub. 

L. 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 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 through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: Application for the 

National Health Service Corps (NHSC) 

Clinician Retention Information: New 

Collection 

The National Health Service Corps 

(NHSC) of the Bureau of Health 

Professions (BHPr), HRSA, is committed 

to improving the health of the Nation’s 

underserved by uniting communities in 

need with caring health professionals 

and by supporting communities’ efforts 

to build better systems of care. 

The NHSC is responsible for 

collecting data on its programs to ensure 

compliance with legislative mandates 

and to report to Congress and 

policymakers on program 

accomplishments. One of the most 

important statistics reported to Congress 

and policymakers is the retention rate of 

NHSC supported clinicians serving in 

an underserved area. The following 

information will be collected three 

months prior to the completion of 

obligated service: (1) Verification of 

current contact information; (2) if 

employment is to be continued at the 

same NHSC site; (3) if the clinician 

moved from the NHSC service site but 

plans to continue practicing in an 

underserved area, and (4) the primary 

reason for stopping practice in an 

underserved area, if applicable. 

The estimated burden is as follows: 

Type of report Number of 

respondents 

Responses 

per 

respondent 

Hours per 

response 

Total burden 

hours 

NHSC Clinical Retention Information .............................................................. 1000 1 0.25 250 

Send comments to Susan G. Queen, 

PhD, HRSA Reports Clearance Officer, 

Room 10–33, Parklawn Building, 5600 

Fishers Lane, Rockville, MD 20857. 

Written comments should be received 

within 60 days of this notice. 

Dated: February 27, 2007. 

Alexandra Huttinger, 

Acting Director, Division of Policy Review 

and Coordination. 

[FR Doc. E7–3901 Filed 3–6–07; 8:45 am] 

BILLING CODE 4165–15–P 

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, Pub. 

L. 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 through the 

use of automated collection techniques 

or other forms of information 

technology. 


sroberts on PROD1PC70 with NOTICES