61624 Federal Register / Vol. 70, No. 205 / Tuesday, October 25, 2005 / Notices 

Dated: October 19, 2005. 

Alvin Hall, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 05–21259 Filed 10–24–05; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0414] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Generic Food and 

Drug Administration Rapid Response 

Surveys 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the use of rapid response surveys to 

obtain data on safety information to 

support quick-turnaround 

decisionmaking about potential safety 

problems or risk management solutions 

from health care professionals, hospitals 

and other user-facilities (e.g., nursing 

homes, etc.); consumers; manufacturers 

of biologics, drugs, and medical devices; 

distributors; and importers when FDA 

must quickly determine whether or not 

a problem with a biologic, drug, or 

medical device impacts the public 

health. 

DATES: Submit written or electronic 

comments on the collection of 

information by December 27, 2005. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn P. Capezzuto, Office of 

Management Programs (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these comments: (1) 

Whether the proposed collection of 

information is necessary for the proper 

performance of FDA’s functions, 

including whether the information will 

have practical utility; (2) the accuracy of 

FDA’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Generic FDA Rapid Response 

Surveys—(OMB Control Number 0910–

0500)—Extension 

Section 505 of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

355), requires that important safety 

information relating to all human 

prescription drug products be made 

available to FDA so that it can take 

appropriate action to protect the public 

health when necessary. Section 702 of 

the act (21 U.S.C. 372) authorizes 

investigational powers to FDA for 

enforcement of the act. Under section 

519 of the act (21 U.S.C. 360i), FDA is 

authorized to require manufacturers to 

report medical device-related deaths, 

serious injuries, and malfunctions to 

FDA; to require user facilities to report 

device-related deaths directly to FDA 

and to manufacturers; and to report 

serious injuries to the manufacturer. 

Section 522 of the act (21 U.S.C. 360l) 

authorizes FDA to require 

manufacturers to conduct postmarket 

surveillance of medical devices. Section 

705(b) of the act (21 U.S.C. 375(b)) 

authorizes FDA to collect and 

disseminate information regarding 

medical products or cosmetics in 

situations involving imminent danger to 

health or gross deception of the 

consumer. Section 903(d)(2) of the act 

(21 U.S.C. 393(d)(2)) authorizes the 

Commissioner of Food and Drugs to 

implement general powers (including 

conducting research) to carry out 

effectively the mission of FDA. These 

sections of the act enable FDA to 

enhance consumer protection from risks 

associated with medical products usage 

that are not foreseen or apparent during 

the premarket notification and review 

process. FDA’s regulations governing 

application for agency approval to 

market a new drug (21 CFR part 314) 

and regulations governing biological 

products (21 CFR part 600) implement 

these statutory provisions. Currently 

FDA monitors medical product related 

postmarket adverse events via both the 

mandatory and voluntary MedWatch 

reporting systems using FDA Forms 

3500 and 3500A (OMB control number 

0910–0291) and the vaccine adverse 

event reporting system. FDA is seeking 

OMB clearance to collect vital 

information via a series of rapid 

response surveys. Participation in these 

surveys will be voluntary. This request 

covers rapid response surveys for 

community based health care 

professionals, general type medical 

facilities, specialized medical facilities 

(those known for cardiac surgery, 

obstetrics/gynecology services, pediatric 

services, etc.), other health care 

professionals, patients, consumers, and 

risk managers working in medical 

facilities. FDA will use the information 

gathered from these surveys to obtain 

quickly vital information about medical 

product risks and interventions to 

reduce risks so the agency may take 

appropriate public health or regulatory 

action including dissemination of this 

information as necessary and 

appropriate. 

Federal Register / Vol. 70, No. 205 / Tuesday, October 25, 2005 / Notices 61625 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of Respondents Annual Frequency per 

Response Total Annual Responses Hours per Response Total Hours 

200 30 (maximum) 6,000 0 .5 3,000 

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

FDA projects 30 emergency risk 

related surveys per year with a sample 

of between 50 and 200 respondents per 

survey. FDA also projects a response 

time of 0.5 hours per response. These 

estimates are based on the maximum 

sample size per questionnaire that FDA 

can analyze in a timely manner. The 

annual frequency of response was 

determined by the maximum number of 

questionnaires that will be sent to any 

individual respondent. Some 

respondents may be contacted only one 

time per year, while other respondents 

may be contacted several times 

annually, depending on the human 

drug, biologic, or medical device under 

evaluation. It is estimated that, given the 

expected type of issues that will be 

addressed by the surveys, it will take 0.5 

hours for a respondent to gather the 

requested information and fill in the 

answers. 

Dated: October 17, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–21240 Filed 10–24–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Clinical Pharmacology Subcommittee 

of the Advisory Committee for 

Pharmaceutical Science; Notice of 

Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Clinical 

Pharmacology Subcommittee of the 

Advisory Committee for Pharmaceutical 

Science. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on November 14, 2005, from 8:30 

a.m. to 5:30 p.m. and on November 15, 

2005, from 8:30 a.m. to 1:30 p.m. 

Location: Food and Drug 

Administration, Center for Drug 

Evaluation and Research Advisory 

Committee Conference Room, rm. 1066, 

5630 Fishers Lane, Rockville, MD. 

Contact Person: Mimi Phan, Center 

for Drug Evaluation and Research (HFD–

21), Food and Drug Administration, 

5600 Fishers Lane (for express delivery, 

5630 Fishers Lane, rm. 1093) Rockville, 

MD 20857, 301–827–7001, FAX: 301–

827–6776, e-mail: phanm@cder.fda.gov, 

or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area), code 3014512539. Please call the 

Information Line for up-to-date 

information on this meeting. 

Agenda: On November 14, 2005, the 

subcommittee will: (1) Receive an 

update on previous Clinical 

Pharmacology Subcommittee meeting 

recommendations and an introduction 

to the topics of this meeting, (2) discuss 

and provide comments on the evidence 

and process for translation of 

pharmacogenetic information (e.g., 

Cytochrome P 2C9 polymorphisms) into 

label updates for approved products, (3) 

discuss current evidence related to the 

pharmacogenetics of warfarin as a 

potential basis for label updates, and (4) 

discuss and provide comments on the 

critical path pilot project, the End-ofPhase 2A meetings which will include 

a case study. On November 15, 2005, the 

subcommittee will discuss and and 

provide comments on: (1) An update on 

the critical path biomarker-surrogate 

endpoint project, (2) the use of 

biomarker information in labels to 

facilitate individualizing 

pharmacotherapy, and (3) the analytical 

and clinical validation criteria for 

approving a clinical assay (‘‘diagnostic 

test’’). The background material will 

become available no later than the day 

before the meeting and will be posted 

on FDA’s Web site at http:// 

www.fda.gov/ohrms/dockets/ac/ 

acmenu.htm under the heading 

‘‘Advisory Committee for 

Pharmaceutical Science.’’ (Click on the 

year 2005 and scroll down to the 

Advisory Committee for Pharmaceutical 

Science meetings.) 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the subcommittee. Written 

submissions may be made to the contact 

person by November 4, 2005. Oral 

presentations from the public will be 

scheduled between approximately 11:15 

a.m. and 11:30 a.m. and 3:35 p.m. and 

3:50 p.m. on November 14, 2005, and 

between approximately 11:20 a.m. and 

11:50 a.m. on November 15, 2005. Time 

allotted for each presentation may be 

limited. Those desiring to make formal 

oral presentations should notify the 

contact person before November 4, 

2005, and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Mimi Phan at 

least 7 days in advance of the meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: October 18, 2005. 

Jason Brodsky, 

Acting Associate Commissioner for External 

Relations. 

[FR Doc. 05–21241 Filed 10–24–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Committee on Infant 

Mortality; 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 Committee on Infant 

Mortality (ACIM).