Federal Register / Vol. 72, No. 55 / Thursday, March 22, 2007 / Notices 13497 

Dated: March 15, 2007. 

James D. Seligman, 

Chief Information Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E7–5216 Filed 3–21–07; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

National Institute for Occupational 

Safety and Health (NIOSH); Advisory 

Board on Radiation and Worker Health 

(ABRWH or Advisory Board), 

Subcommittee for Dose 

Reconstruction Reviews (SDRR) 

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

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention announces the 

following meeting of the 

aforementioned subcommittee: 

Subcommittee Meeting Time and Date: 10 

a.m.–5 p.m., April 11, 2007. 

Place: Cincinnati Airport Marriott, 2395 

Progress Drive, Hebron, KY 41018. Phone 

859.334.4611, Fax 859.334.4619. 

Conference Call Access: Phone 

866.643.6504, Participant Pass Code 

9448550. 

Status: Open to the public. 

Background: The Advisory Board was 

established under the Energy Employees 

Occupational Illness Compensation Program 

Act of 2000 to advise the President on a 

variety of policy and technical functions 

required to implement and effectively 

manage the new compensation program. Key 

functions of the Advisory Board include 

providing advice on the development of 

probability of causation guidelines that have 

been promulgated by the Department of 

Health and Human Services (HHS) as a final 

rule, advice on methods of dose 

reconstruction which have also been 

promulgated by HHS as a final rule, advice 

on the scientific validity and quality of dose 

estimation and reconstruction efforts being 

performed for purposes of the compensation 

program, and advice on petitions to add 

classes of workers to the Special Exposure 

Cohort. 

In December 2000, the President delegated 

responsibility for funding, staffing, and 

operating the Advisory Board to HHS, which 

subsequently delegated this authority to CDC. 

NIOSH implements this responsibility for 

CDC. The charter was issued on August 3, 

2001, renewed at appropriate intervals, and 

will expire on August 3, 2007. 

Purpose: The Advisory Board is charged 

with (a) Providing advice to the Secretary, 

HHS, on the development of guidelines 

under Executive Order 13179; (b) providing 

advice to the Secretary, HHS, on the 

scientific validity and quality of dose 

reconstruction efforts performed for this 

program; and (c) upon request by the 

Secretary, HHS, providing advice to the 

Secretary on whether there is a class of 

employees at any Department of Energy 

facility who were exposed to radiation but for 

whom it is not feasible to estimate their 

radiation dose, and on whether there is 

reasonable likelihood that such radiation 

doses may have endangered the health of 

members of this class. 

Matters To Be Discussed: Need for Basic vs. 

Advanced Reviews; How to Conduct Blind 

Reviews; Status of Individual Dose 

Reconstruction Audits; Planning Future Dose 

Reconstruction Audits; and Assignment of 

Two Board Member Teams to Oversee Audit 

Process. 

The agenda is subject to change as 

priorities dictate. There is no public 

comment period, however, written comments 

may be submitted. Any written comments 

received will be provided at the meeting and 

should be submitted to the contact person 

below well in advance of the meeting. 

Contact Person for Further Information: Dr. 

Lewis V. Wade, Executive Secretary, NIOSH, 

CDC, 4676 Columbia Parkway, Cincinnati, 

OH 45226, Telephone 513.533.6825, Fax 

513.533.6826. 

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. 

Elaine L. Baker, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. E7–5225 Filed 3–21–07; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

The National Institute for Occupational 

Safety and Health (NIOSH) of the 

Centers for Disease Control and 

Prevention Announces the Following: 

Implementation of New Record 

Schedule 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: NIOSH is implementing a 

new record schedule governing the 

retention of records transferred to the 

agency by employers pursuant to the 

regulations of the Occupational Safety 

and Health Administration (OSHA). 

Pursuant to this schedule, NIOSH will 

review these records to determine if 

they document exposures or medical 

conditions as required under the OSHA 

regulations and have research value. 

Those records that NIOSH determines 

meet the OSHA regulations and have a 

research value will be retained for 30 

years. 

Those records that do not document 

exposure or medical condition and 

treatment or have no research value will 

not be retained. 

SUPPLEMENTARY INFORMATION: The 

hazard-specific standards of the 

Occupational Safety and Health 

Administration (OSHA)(Title 29, Code 

of Federal Regulations [CFR], Parts 

1910.1001 through 1910.1450) contain 

requirements stating that when a 

company closes and leaves no successor 

employer, it must transfer (or in some 

instances, offer to transfer) its 

employee’s medical and exposure 

records to NIOSH. The OSHA 

carcinogens standards (29 CFR 

1910.1003–1910.1016) also require that 

such records be transferred to NIOSH 

when an employee resigns, retires, or 

dies. The transfer of these records to 

NIOSH is intended to preserve them for 

research purposes. 

NIOSH has amended its record 

schedule pertaining to these records, 

Employee Exposure and Medical 

Records (NIOSH), (NARA job Number 

N1–442–98–1, Item 2), Item 2–80 in the 

CDC Records Control Schedule (RCS) B–

321, to reduce the retention period of 

those records and permit the destruction 

of the records which do not serve any 

research purpose. Under the new 

schedule, those records that meet the 

requirements of the OSHA regulations 

and serve a research purpose will now 

be retained for 30 years, rather than 40 

years (as under the previous record 

schedule). However, if upon review 

NIOSH determines that the records are 

not medical records or exposure records 

required to be transferred to NIOSH or 

were not systematically collected and 

will not serve a research purpose, the 

records will not be retained and will be 

destroyed. 

On September 16, 2005, the National 

Archives and Records Administration 

(NARA) published in the Federal 

Register [70(179):54774–54776] a notice 

of availability of this proposed record 

schedule, Employee Exposure and 

Medical Records (NIOSH), (NARA job 

number N1–442–2005–1, Item 1) and 

request for comments. Following receipt 

and review of comments, NARA 

approved this revised record schedule 

on December 16, 2005. This notice 

announces adoption of the revised 

schedule by NIOSH. A copy of the 

revised record schedule can be obtained 

from NIOSH. 

FOR FURTHER INFORMATION CONTACT: 

Rodger Tatken, National Institute for 

Occupational Safety and Health, Robert 

A. Taft Laboratories, 4676 Columbia 


rwilkins on PROD1PC63 with NOTICES
13498 Federal Register / Vol. 72, No. 55 / Thursday, March 22, 2007 / Notices 

Parkway, Cincinnati, OH 45226 (513) 

533–8370. 

Dated: March 14, 2007. 

James D. Seligman, 

Chief Information Officer, Center for Disease 

Control and Prevention. 

[FR Doc. E7–5219 Filed 3–21–07; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0092] 

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 May 21, 2007. 

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: 

Jonna Capezzuto, Office of the Chief 

Information Officer (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 topics: (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 Food and Drug Administration 

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. 

FDA estimates the burden of this 

collection of information as follows: 


rwilkins on PROD1PC63 with NOTICES