Federal Register / Vol. 70, No. 205 / Tuesday, October 25, 2005 / Notices 61623 

Road, NE., Atlanta, Georgia 30333, 

telephone 1–(888)422–8737 or 

(770)488–3315. 

SUPPLEMENTARY INFORMATION: The 

Superfund Amendments and 

Reauthorization Act (SARA) (Pub. L. 

99–499) amends the Comprehensive 

Environmental Response, 

Compensation, and Liability Act 

(CERCLA or Superfund) (42 U.S.C. 9601 

et seq.) by establishing certain 

responsibilities for the ATSDR and the 

U.S. Environmental Protection Agency 

(EPA) with regard to hazardous 

substances which are most commonly 

found at facilities on the CERCLA 

National Priorities List (NPL). Among 

these responsibilities is that the 

Administrator of ATSDR prepare 

toxicological profiles for substances 

included on the priority lists of 

hazardous substances. These lists 

identified 275 hazardous substances 

that ATSDR and EPA determined pose 

the most significant potential threat to 

human health. The availability of the 

revised priority list of 275 hazardous 

substances was announced in the 

Federal Register on November 7, 2003 

(68 FR 63098). For prior versions of the 

list of substances see Federal Register 

notices dated April 17, 1987 (52 FR 

12866); October 20, 1988 (53 FR 41280); 

October 26, 1989 (54 FR 43619); October 

17, 1990 (55 FR 42067); October 17, 

1991 (56 FR 52166); October 28, 1992 

(57 FR 48801); February 28, 1994 (59 FR 

9486); April 29, 1996 (61 FR 18744); 

November 17, 1997 (62 FR 61332); 

October 21, 1999 (64 FR 56792) and 

October 25, 2001 (66 FR 54014). 

[CERCLA also requires ATSDR to assure 

the initiation of a research program to 

fill data needs associated with the 

substances.] Section 104(i)(3) of 

CERCLA [42 U.S.C. 9604(i)(3)] outlines 

the content of these profiles. Each 

profile will include an examination, 

summary and interpretation of available 

toxicological information and 

epidemiologic evaluations. This 

information and these data are to be 

used to identify the levels of significant 

human exposure for the substance and 

the associated health effects. The 

profiles must also include a 

determination of whether adequate 

information on the health effects of each 

substance is available or in the process 

of development. When adequate 

information is not available, ATSDR, in 

cooperation with the National 

Toxicology Program (NTP), is required 

to assure the initiation of research to 

determine these health effects. 

Although key studies for each of the 

substances were considered during the 

profile development process, this Federal 

Register notice seeks to solicit any additional 

studies, particularly unpublished data and 

ongoing studies, which will be evaluated for 

possible addition to the profiles now or in 

the future. 

The following draft toxicological 

profiles will be made available to the 

public on or about October 17, 2005. 

Document Hazardous substance CAS No. 

1 ............................................... ACROLEIN (Update) ................................................................................................................. 000107–02–8 

2 ............................................... ARSENIC (Update) .................................................................................................................... 007440–38–2 

3 ............................................... BARIUM (Update) ...................................................................................................................... 007440–39–3 

4 ............................................... BENZENE (Update) ................................................................................................................... 000071–43–2 

5 ............................................... HEPTACHLOR (Update)/ .......................................................................................................... 000076–44–8 

HEPTACHLOR EPOXIDE ......................................................................................................... 001024–57–3 

6 ............................................... LEAD (Update) .......................................................................................................................... 007439–92–1 

7 ............................................... PERCHLORATES * .................................................................................................................... 014797–73–0 

8 ............................................... XYLENES (Update) ................................................................................................................... 001330–20–7 

* Denotes new profile. 

All profiles issued as ‘‘Drafts for 

Public Comment’’ represent ATSDR’s 

best efforts to provide important 

toxicological information on priority 

hazardous substances. We are seeking 

public comments and additional 

information which may be used to 

supplement these profiles. ATSDR 

remains committed to providing a 

public comment period for these 

documents as a means to best serve 

public health and our clients. 

Dated: October 17, 2005. 

Ken Rose, 

Acting Director, Office of Policy, Planning 

and Evaluation, National Center for 

Environmental Health/Agency for Toxic 

Substances and Disease Registry. 

[FR Doc. 05–21254 Filed 10–24–05; 8:45 am] 

BILLING CODE 4163–70–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Committee on Childhood 

Lead Poisoning Prevention 

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

the Federal Advisory Committee Act 

(Pub. L. 92–463), the National Center for 

Environmental Health (NCEH) of the 

Centers for Disease Control and 

Prevention (CDC) announces the 

following committee meeting: 

Correction. 

Name: Advisory Committee on 

Childhood Lead Poisoning Prevention 

(ACCLPP). 

Summary: The Department of Health 

and Human Services, CDC published a 

document in the Federal Register of 

September 20, 2005, concerning the 

ACCLPP. 

Correction: In the Federal Register of 

September 20, 2005, (Volume 70, 

Number 1811) [Notices] Page 55132 

‘‘Place: The Hubert Humphrey Federal 

Building, 200 Independence Avenue, 

Washington, DC 20021’’ Should read: 

330 Independence Avenue, Room 5051, 

Snow Room Cohen Building, 

Washington, DC 20201. Telephone: 

202–619–0814. 

Contact Person For More Information: 

Claudine Johnson, Lead Poisoning 

Prevention Branch, Division of 

Emergency and Environmental Health 

Services, NCEH, CDC, 4770 Buford 

Hwy, NE., M/S F–40, Atlanta, Georgia 

30341. Telephone: (770) 488–3300, fax: 

(770) 488–3635. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities for both CDC and 

the Agency for Toxic Substances and 

Disease Registry. 

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.