Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices 42559

DATES: Comments concerning this

notice and the interim guidelines must

be received by October 6, 1997.

ADDRESSES: Requests for a copy of these

documents should be sent to the

attention of Ms. Kim E. Jenkins,

Division of Toxicology, Agency for

Toxic Substances and Disease Registry,

Mailstop E–29, 1600 Clifton Road, NE

Atlanta, Georgia 30333. Requests for the

documents must be in writing.

Comments on this notice should bear

the docket control number ATSDR–123

and should be sent to the attention of

Dr. Jim Holler, Agency for Toxic

Substances and Disease Registry,

Division of Toxicology, Emergency

Response and Scientific Assessment

Branch, 1600 Clifton Road, NE Mailstop

E–29, Atlanta, Georgia 30333.

Comments on this notice will be

available for public inspection at the

Agency for Toxic Substances and

Disease Registry, Building 4, Executive

Park Drive, Atlanta, Georgia (not a

mailing address), from 8 a.m. until 4:30

p.m., Monday through Friday, except for

legal holidays. Because all public

comments are available for public

inspection, no confidential business

information should be submitted in

response to this notice.

FOR FURTHER INFORMATION CONTACT: Dr.

Christopher T. De Rosa, Director,

Division of Toxicology, Agency for

Toxic Substances and Disease Registry,

1600 Clifton Road, NE Mailstop E–29,

Atlanta, Georgia 30333, telephone (404)

639–6300.

SUPPLEMENTARY INFORMATION: This

interim policy guideline provides a

description of ATSDR’s current

approaches and judgments regarding

hazards posed by the presence of TCDD

and its less toxic dioxin-like congeners,

the CDDs and CDFs, in residential soils.

Likely users of this interim policy

guideline include health assessors at

ATSDR and in the States, and ATSDR

partners including relevant Federal,

State, and local health and

environmental entities, and concerned

community groups who may be

involved in a range of health assessment

and risk management decisions.

The technical support document is

intended to serve as technical

background and support for the agency

interim policy guideline and, to the

extent practicable, harmonize such

efforts with those of other Federal

agencies and relevant organizations.

This document reflects an assessment of

current practice within the agency and

defines the appropriate roles of

professional judgment and emerging

scientific principles in ATSDR’s public

health assessments of exposures to

dioxin and dioxin-like compounds.

These guidelines and procedures

apply to human exposure by direct

ingestion of soils contaminated with

dioxin and dioxin-like compounds in

residential areas and may not be

appropriate for exposure by other routes

or media. This guidance will be

evaluated in the future in view of new

data that may become available.

Dated: July 31, 1997.

Georgi Jones,

Director, Office of Policy and External Affairs,

Agency for Toxic Substances and Disease

Registry.

[FR Doc. 97–20740 Filed 8–6–97; 8:45 am]

BILLING CODE 4163–70–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0040]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by September

8, 1997.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Wolff, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed

collection of information to OMB for

review and clearance.

Survey of Food Safety Practices of Food

Processing Firms—New Collection

FDA is evaluating the marginal costs

of requiring food processors to use

Hazard Analysis and Critical Control

Point (HACCP) systems. HACCP is

already required for seafood processors,

and FDA is considering whether to issue

regulations requiring HACCP for

processors of other foods under the

agency’s jurisdiction. The analysis of

marginal costs requires information

about the prevalence of specific HACCP

systems and practices among food

manufacturers and repackers. FDA will

collect this information through an

anonymous voluntary survey of a

random sample of food processors.

Additionally, through a series of onsite

visits to selected processors, a

contractor will collect information on

the marginal cost of various procedures

required to operate a HACCP system.

The information will help the Center for

Food Safety and Applied Nutrition

determine the baseline level of HACCP

use from which to estimate the

economic costs to the industry of

mandatory HACCP regulations for foods

other than seafood. FDA will use this

information in tailoring any HACCP

regulations that may issue so that costs

and benefits of such regulations are

appropriately considered.

In the Federal Register of February

28, 1997 (62 FR 9194), the agency

requested comments on the proposed

collection of information. FDA received

one comment that supported the

implementation of HACCP but

questioned several aspects associated

with the proposed survey. First, the

comment questioned whether the

survey would yield ‘‘reliable’’ or

‘‘practical’’ data because it was difficult

to interpret what ‘‘critical control point’’

means and what the term ‘‘hazards’’

includes. The comment stated ‘‘it is

difficult to identify costs attributable

only to HACCP in facilities where the

system has been implemented.’’ This

comment is not relevant to the survey

because the survey does not ask

processors about critical control points,

hazards, or costs of HACCP but, instead,

seeks information on the processes and

controls currently in place.

The comment also stated that FDA

should use other sources of data. In fact,

FDA is already planning to used

multiple sources of information to

estimate the marginal costs of requiring

HACCP. These sources include

interviews with food processing firms

and information taken from pilot plants

that are already using HACCP, and

comments received during other HACCP

rulemakings.
42560 Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices

Finally, the comment stated that

FDA’s reporting burden estimate is too

low because successful telephone

contact typically requires multiple

attempts. FDA disagrees with this

comment for two reasons: First, the

burden of making multiple attempts to

contact a potential survey respondent

will fall on FDA, not on the potential

respondent. Second, the burden

estimate already includes time to be

spent by respondents to set up a

subsequent interview.

FDA estimates the burden of this

survey as follows:

ESTIMATED ANNUAL REPORTING BURDEN

Burden Element No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Part 1—Computer Assisted Telephone Interview

(CATI)

Respond to initial recruitment telephone call 1,231 1 1,231 0.2 246.2

Receive and read introductory letter, key term

definitions 1,231 1 1,231 0.25 307.75

Obtain data to prepare for the telephone interview 1,231 1 1,231 0.35 430.85

Respond to telephone interview 1,231 1 1,231 0.5 615.50

Totals 1 1,600.3

Part 2—Onsite Cost Interview

Receive initial recruitment telephone call 17 1 17 0.2 3.4

Receive and read introductory letter and materials 17 1 17 0.25 4.25

Obtain data to prepare for the site visit 17 1 17 0.5 8.5

Respond to questions during site visit 17 1 17 3.0 51.0

Followup questions 17 1 17 0.25 4.25

Total burden hours, onsite interviews 71.4

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

The total burden hours for Part 1—

CATI and Part 2—Onsite Cost Interview

are 1,671.7.

The burden hour estimates are based

on a pretest conducted with three focus

groups.

Dated: July 30, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–20754 Filed 8–6–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0317]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by September

8, 1997.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Wolff, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed

collection of information to OMB for

review and clearance.

Interstate Shellfish Dealers

Certificate—(OMB Control Number

0910– 0021)—Reinstatement

Under 42 U.S.C. 243, FDA is required

to cooperate with and aid State and

local authorities in the enforcement of

their health regulations and is

authorized to assist States in the

prevention and suppression of

communicable diseases. Under this

authority, FDA participates with State

regulatory agencies, some foreign

nations, and the molluscan shellfish

industry in the National Shellfish

Sanitation Program (NSSP). The NSSP is

a voluntary, cooperative program to

promote the safety of molluscan

shellfish by providing for the

classification and patrol of shellfish

growing waters and for the inspection

and certification of shellfish processors.

Each participating State and foreign

nation monitors its molluscan shellfish

processors and issues certificates for

those that meet the State or foreign

shellfish control authority’s criteria.

Each participating State and nation

provides a certificate of its certified

shellfish processors to FDA on Form

FDA 3038, ‘‘Interstate Shellfish Dealer’s

Certificate.’’ FDA uses this information

to publish the ‘‘Interstate Certified

Shellfish Shippers List,’’ a monthly

comprehensive listing of all molluscan

shellfish processors certified under the

cooperative program. If FDA did not

collect the information necessary to

compile this list, participating States

would not be able to identify and keep

out shellfish processed by uncertified

processors in other States and foreign

nations. Consequently, the NSSP would

not be able to control the distribution of

uncertified and possibly unsafe shellfish

in interstate commerce, and its

effectiveness would be nullified.