Federal Register / Vol. 62, No. 206 / Friday, October 24, 1997 / Notices 55407

construction, repair, and alteration or

lease contracts.

DATES: December 23, 1997.

ADDRESSES: Send comments to Edward

Springer, GSA Desk Officer, Room 3235,

NEOB, Washington, DC 20503, and to

Marjorie Ashby, General Services

Administration (MVP), 18th and F

Streets, NW, Washington, DC 20405.

Annual Reporting Burden:

Respondents: 1350; annual responses: 1;

average hours per response: 12; burden

hours: 16,200.

FOR FURTHER INFORMATION CONTACT: Al

Matera, Office of GSA Acquisition

Policy (202) 501–1224.

Copy of Proposal: A copy of this

proposal may be obtained from the GSA

Acquisition Policy Division (MVP),

Room 4011, GSA Building, 18th and F

Streets NW, Washington, DC 20405, or

by telephoning (202) 501–3822, or by

faxing your request to (202) 501–3341.

Dated: October 15, 1997.

Edward C. Loeb,

Acting Deputy Association Administrator,

Office of Acquisition Policy.

[FR Doc. 97–28236 Filed 10–23–97; 8:45 am]

BILLING CODE 6820–61–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

National Institute for Occupational

Safety and Health; Occupational

Exposure to Inorganic Lead: Request

for Comments and Information;

Republication

This notice is being republished

because the μ symbol was missing

throughout the original document

published in the Federal Register on

October 7, 1997 (62 FR 52343).

AGENCY: National Institute for

Occupational Safety and Health

(NIOSH), Centers for Disease Control

and Prevention (CDC), Department of

Health and Human Services (DHHS).

ACTION: Request for comments and

information relevant to occupational

exposure to inorganic lead.

SUMMARY: NIOSH is reviewing its

recommendations contained in the

document Criteria for a Recommended

Standard....Occupational Exposure to

Inorganic Lead, Revised Criteria—1978

[NIOSH 1978]. The evaluation of recent

literature indicates that the NIOSH

recommended exposure limit (REL) of

100 μg/m3 as an 8-hour time-weighted

average (TWA) in that document does

not sufficiently protect workers from the

adverse effects of exposure to inorganic

lead. NIOSH is requesting comments

and information relevant to the

evaluation of the potential health risks

associated with occupational exposure

to inorganic lead, as well as case reports

or other data that demonstrate adverse

health effects in workers exposed to

inorganic lead at or below the OSHA

permissible exposure limit (PEL) of 50

μg/m3 as an 8-hour TWA and any

information pertinent to evaluating the

technical feasibility of establishing a

more protective REL for inorganic lead.

NIOSH is also soliciting information on

worker blood lead levels (BLLs)

including data on methodologies used

in measuring BLLs in the workplace and

information that can be used for

comparing airborne inorganic lead

concentrations to observed BLLs.

NIOSH intends to analyze the

feasibility of developing preventive

measures including an REL that would

provide better protection for workers. In

the interim, NIOSH plans to adopt the

more protective current OSHA PEL as

its REL.

DATES: Written comments to this notice

should be submitted to Diane Manning,

NIOSH Docket Office, 4676 Columbia

Parkway, M/S C–34, Cincinnati, Ohio

45226, on or before December 23, 1997.

Comments may also be faxed to Diane

Manning at (513) 533–8285 or submitted

by email to dmm2@cdc.gov as

WordPerfect 6.0/6.1 files.

FOR FURTHER INFORMATION CONTACT:

Technical information may be obtained

from Dr. Henryka Nagy, NIOSH, CDC,

4676 Columbia Parkway, M/S C–32,

Cincinnati, Ohio 45226, telephone (513)

533–8369.

SUPPLEMENTARY INFORMATION: NIOSH

has conducted a literature review of the

health effects data on inorganic lead

exposure and finds evidence that some

adverse effects on the adult

reproductive, cardiovascular, and

hematologic systems, and on the

development of children of exposed

workers can occur at BLLs as low as 10

μg/dl with no apparent threshold. At

BLLs below 40 μg/dl, many of the health

effects associated with lead exposure

would not necessarily be evident by

routine physical examinations, but

represent early stages in a continuum of

disease development. The risk of

developing adverse health effects

appears to increase as BLLs rise above

40 μg/dl.

In the NIOSH 1978 criteria document

entitled Occupational Exposure to

Inorganic Lead [NIOSH 1978], NIOSH

recommended that exposure to

inorganic lead be limited to 100 μg/m3

as an 8-hour TWA. This exposure limit

was expected to maintain BLLs below

60 μg/dl and to prevent clinical health

effects to the hematologic system, the

central and peripheral nervous systems,

the reproductive system, and the

kidneys. NIOSH also expressed concern

about possible health effects that may

occur below 60 μg/dl: ‘‘In adhering to

the 60 μg/dl figure, NIOSH has not

relinquished its concerns for possible

effects that may occur below 60 μg/dl.

Adherence to this 60 μg/dl figure should

not be interpreted as a firm NIOSH

opposition to establishing a lower blood

lead standard. In fact, NIOSH endorses

a lower blood lead standard as a future

goal to provide greater assurance of

safety.’’

In 1978, the Occupational Safety and

Health Administration (OSHA)

promulgated an occupational inorganic

lead standard for general industry that

incorporates a PEL of 50 μg/m3 which is

intended to maintain worker BLLs

below 40 μg/dl. OSHA also included

provisions for reducing the PEL for

work shifts that exceed 8 hours, medical

monitoring of workers exposed to

airborne inorganic lead concentrations

at or above the action level of 30 μg/m3,

and medical removal of workers with

BLLs greater than 50 μg/dl. Workers are

permitted to return to jobs involving

inorganic lead exposure only after their

BLLs have declined to 40 μg/dl.

OSHA concluded in 1978 that a PEL

of 50 μg/m3 represented the lowest level

for which there was evidence of

feasibility in most industries. OSHA

also acknowledged that, based on the

scientific data, the PEL of 50 μg/m3 did

not provide protection from all adverse

health effects of inorganic lead toxicity

because the hematologic system, the

nervous system, the kidneys, and the

fetus can be adversely affected by

exposures to inorganic lead resulting in

BLLs below 40 μg/dl [43 FR 52952,

November 14, 1978]. In May 1993,

OSHA published the Interim Final Lead

in Construction Standard [58 FR 26590,

May 4, 1993]. This standard extended

the general industry standard for

inorganic lead to include workers in the

construction industry. No additional

analysis of the health data was

performed by OSHA in adopting this

standard for the construction industry.

NIOSH seeks to obtain materials,

including reports and research findings,

to evaluate the health risks of

occupational exposure to inorganic lead.

Examples of requested information

include, but are not limited to, the

following:

1. Occupational (environmental)

exposure data.

2. Data on the effectiveness of

engineering controls, work practices,
55408 Federal Register / Vol. 62, No. 206 / Friday, October 24, 1997 / Notices

training, personal protective equipment

and other activities used to limit

workers’ exposure.

3. Identification of industries or

occupations where intermittent or low

concentrations of inorganic lead may

occur.

4. Descriptions of work practices and

engineering controls used to reduce

workplace exposure.

5. Case reports or other health data

that demonstrate adverse health effects

in workers exposed to inorganic lead at

or below the OSHA PEL and any

information pertinent to evaluating the

feasibility of establishing a more

protective exposure limit. Case reports

and health data should be submitted

without personal identifiers.

6. Information regarding methods for

BLL determination that could be used

routinely in the workplace (e.g.,

determination of BLLs using portable

equipment). NIOSH is evaluating

whether the routine biological

monitoring of inorganic lead exposed

workers (through BLLs) may be a more

appropriate measure than airborne

concentrations for estimating the

potential for developing adverse health

effects.

This information will be used by

NIOSH to determine the need for

developing new recommendations for

lowering the occupational exposure to

inorganic lead and improving strategies

for monitoring inorganic lead exposure.

All information received in response

to this notice will be available for public

examination and copying at the NIOSH

Docket Office, 4676 Columbia Parkway,

Cincinnati, Ohio 45226.

References

43 FR 52952, November 14, 1978. Chapter

XVII—Occupational Safety and Health

Administration, Department of Labor; Part

1910—Occupational safety and health

standards: occupational exposure to lead.

58 FR 26590, May 4, 1993. Occupational

Safety and Health Administration: lead

exposure in construction; interim final rule.

(To be codified at 29 CFR 1926.)

NIOSH [1978]. Criteria for a recommended

standard * * * occupational exposure to

inorganic lead, revised criteria. Rockville,

MD: U.S. Department of Health, Education,

and Welfare, Public Health Service, Center

for Disease Control, National Institute for

Occupational Safety and Health, DHEW

(NIOSH) Publication No. 78–158.

Dated: October 20, 1997.

Linda Rosenstock,

Director, National Institute for Occupational

Safety and Health (NIOSH), Centers for

Disease Control and Prevention (CDC).

[FR Doc. 97–28219 Filed 10–23–97; 8:45 am]

BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0424]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on a

proposed revision of the form for the

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 and

to allow 60 days for public comment in

response to the notice. This notice

solicits comments on a revised,

harmonized transmittal form,

‘‘Transmittal of Advertisements and

Promotional Labeling for Drugs and

Biologics for Human Use’’ (Form FDA

2253). This revised and harmonized

form will be used for the submission of

advertisements and promotional

labeling for prescription drugs,

antibiotics, and biological products that

are regulated by the Center for Drug

Evaluation and Research (CDER) and the

Center for Biologics Evaluation and

Research (CBER).

DATES: Submit written comments on the

collection of information by December

23, 1997.

ADDRESSES:

CDER Information: Submit written

requests for single copies of the

revised, harmonized transmittal

form, Form FDA 2253, to the Drug

Information Branch (HFD–210),

Division of Communications

Management, Center for Drug

Evaluation and Research, Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–

594–1012. Send one self-addressed

adhesive label to assist that office in

processing your requests. The form

may also be obtained by calling the

CDER Fax–on–Demand System at

1–800–342–2722 or 1–301–827–

0577.

CBER Information: Submit written

requests for single copies of the

revised, harmonized transmittal

form, Form FDA 2253, to the Office

of Communications, Training, and

Manufacturers Assistance (HFM–

40), Center for Biologics Evaluation

and Research, Food and Drug

Administration, 1401 Rockville

Pike, Rockville, MD 20852–1448.

Send one self-addressed adhesive

label to assist that office in

processing your requests. The form

may also be obtained by calling the

CBER Voice Information System at

1–800–835–4709.

Submit written comments on the

revised, harmonized transmittal form,

Form FDA 2253, and its proposed use

in collection of information, to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. Two copies of any

comments are to be submitted except

that individuals may submit one copy.

Requests and comments should be

identified with the docket number

found in brackets in the heading of this

document. A copy of the revised,

harmonized transmittal form, Form FDA

2253, and received comments are

available for public examination in the

Dockets Management Branch (address

above) between 9 a.m. and 4 p.m.,

Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1472.

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

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information listed below.

With respect to the following

collection of information, FDA invites

comments on: (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;