68150 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Notices

Commissioned Corps promotion and

awards programs; and (4) maintains

liaison and coordinates personnel

services for Commissioned Corps

personnel with the Division of

Commissioned Personnel.

Central Staffing Section (CAD536). (1)

Implements a centralized staffing and

placement program; (2) administers the

delegated examining authority, the

direct hiring authority, and the

temporary limited appointment

authority granted by USOPM; (3)

oversees the overall staffing process and

insures quality control; (4) reviews,

evaluates, and makes recommendations

on the application and implementation

of the USOPM delegated authorities and

merit promotion program rules and

regulations; (5) provides guidance and

consultation in job analyses and in

development of knowledge/skills/

abilities (KSAs) crediting plans; and (6)

manages various staffing programs such

as the CDC summer program, the

Voluntary Employee Referral Program,

the Interagency Career Transition

Assistance Program, and the Career

Transition Assistance Program.

Technical Services Section (CAD357).

(1) Provides central personnel services

and assistance in the areas of employee

benefits, personnel action processing,

data quality control/assessment, and

files/records management; (2) services

as liaison between CDC and the HHS

payroll office resolving discrepancies

with pay and leave; (3) administers the

leave donor program and processes time

and attendance amendments; (4)

provides policy guidance and technical

advice and assistance on retirement, the

Thrift Savings Plan, health/life

insurance, and savings bonds; (5) codes

and finalizes all personnel actions in the

automated personnel data system; (6)

assists with new employee orientation;

(7) establishes and maintains the official

personnel files system and administers

personnel records storage and disposal

program; (8) responds to employment

verification inquiries; (9) administers

the personnel security program; (10)

initiates suitability background checks

and fingerprints for all CDC personnel;

and (11) provides assistance in the

implementation of the HHS Plan for a

Drug Free Workplace.

Information Technology and Analysis

Branch (CAD36). (1) Develops strategic

plans for information technology and

information systems to support CDC’s

and HRMO’s personnel information

requirements; (2) acquires and

implements appropriate technology and

develops information systems to meet

CDC-wide information needs on

personnel, staffing, and work force

characteristics and trends; (3) provides

support to HRMO organizations and

users in achieving automation of

functions and use of information

technology and systems; (4) develops,

manages, and supports centralized

information technology and systems in

support of personnel activities,

including the HHS personnel system; (5)

researches and develops new sources of

personnel information and access

methods including computer-based

CDC-wide surveys; (6) coordinates

HRMO information resource

management activities with IRMO and

CDC information resource management

committees; (7) conducts demographic

analysis of the CDC work force and

publishes results in management

reports; and (8) develops methodologies

to assess the impact of revised

personnel policies and practices on the

work force.

Outreach and Marketing Branch

(CAD37). (1) Develops and implements

human resource management marketing

campaigns; (2) provides leadership in

identifying the Centers/Institute/Offices’

(CIOs) recruiting needs, and assesses,

analyzes, and develops CDC’s short- and

long-range recruitment plans to meet

these needs; (3) provides consultation,

guidance, and technical advice on

recruitment and special emphasis

policies, practices, and procedures,

including search committees; (4)

strategizes on the best approach to

recruitment at specific events, and

designs and develops recruitment

materials for events; (5) maintains and

manages the Automated Applicant

Listing System (AALS/Resumix) for

storage and retrieval of applications of

those individuals with education and

experience appropriate for commonly

needed and hard-to-fill positions;

coordinates, with CIOs, the referral of

appropriate candidates from the

applicant pool for position vacancies;

(6) provides leadership on recruitment

activities through the development of

policies and practices for effective

communication of HRMO programs,

coordinates the development and

dissemination of information among

HRMO and the CIOs, provides training

and technical assistance to CIO staff; (7)

manages and operates the CDC Job

Information Center, including the

automated telephone job line; (8)

markets and manages special emphasis

programs including the Program for

Persons with Disabilities and the

Disabled Veterans Affirmative Action

Program, the Veterans Readjustment

Appointment Program, the Federal

Equal Opportunity Recruitment

Program, and college relations and

student employment programs; and (9)

provides leadership in assessing

progress in achieving overall staffing,

EEO, and Affirmative Action goals.

Delegations of Authority Statement

All delegations and redelegations of

authority remain in effect until

otherwise modified, superseded, or

cancelled.

Section C–C, Order of Succession

Delete in its entirety Section C–C,

Order of Succession, and insert the

following:

During the absence or disability of the

Director, CDC, or in the event of a

vacancy in that office, the first official

listed below who is available shall act

as Director, except that during a

planned period of absence, the Director

may specify a different order of

succession:

1. Deputy Director for Science and

Public Health;

2. Deputy Director for Policy and

Legislation;

3. Deputy Director for Program

Management.

Dated: October 30, 2000.

Jeffrey P. Koplan,

Director.

[FR Doc. 00–29023 Filed 11–13–00; 8:45 am]

BILLING CODE 4160–18–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1555]

Draft Guidance for Industry on Refusal

of Inspection or Access to HACCP

Records Pertaining to the Safe and

Sanitary Processing of Fish and

Fishery Products; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

industry entitled ‘‘Refusal of Inspection

or Access to HACCP Records Pertaining

to the Safe and Sanitary Processing of

Fish and Fishery Products.’’ This draft

guidance sets forth the agency’s

interpretation of its Hazard Analysis

Critical Control Point (HACCP)

regulations for fish and fishery products

as they pertain to the inspection of

facilities and records. The agency is

clarifying that a processor’s refusal to

allow FDA to inspect its processing

facilities, or to provide HACCP records

or plans to an inspector during an

inspection, violates the regulations and

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Notices 68151

thus may trigger a regulatory response

by the agency. FDA is issuing this

clarification because some domestic

firms have questioned whether records

can be made available after an

inspection (rather than during) and

some foreign firms have canceled

scheduled inspections by FDA, but

offered to make records available for

review. This guidance applies to foreign

processors that export fish and fishery

products to the United States as well as

to domestic processors.

DATES: Submit written comments on the

draft guidance by December 14, 2000.

General comments on agency guidance

documents are welcome at any time.

ADDRESSES: Copies of this draft

guidance for industry are available on

the Internet at http://vm.cfsan.fda.gov/

dms/guidance.html. Submit written

requests for single copies of the draft

guidance to the Industry Activities Staff,

Office of Constituent Operations (HFS–

565), Center for Food Safety and

Applied Nutrition, Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204. Send one selfaddressed adhesive label to assist that

office in processing your reuqests.

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Mary I. Snyder, Center for Food Safety

and Applied Nutrition (HFS–415), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3133.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance for industry entitled ‘‘Refusal

of Inspection or Access to HACCP

Records Pertaining to the Safe and

Sanitary Processing of Fish and Fishery

Products.’’ This guidance is intended to

clarify that on-site inspection of a

processing facility and concurrent

review of HACCP records are essential

elements of FDA’s Seafood HACCP

program as set forth at part 123 (21 CFR

part 123). These regulations require

processors of fish and fishery products

to operate preventive control systems

for human food safety that incorporate

the principles of HACCP. The

regulations further provide that fish and

fishery products are adulterated under

section 402(a)(4) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 342(a)(4)) if their processor fails

to have and implement a HACCP plan

when one is necessary, or otherwise

fails to meet any of the requirements of

the regulations, including allowing the

official review of records (§ 123.6(g)).

Processors must make their HACCP

records and plans available ‘‘for official

review and copying at reasonable times’’

(§ 123.9(c)). The agency expects that it

will regard the failure to provide records

and plans by a domestic or foreign

processor as a significant program

violation, even if a firm volunteers the

documents after the inspection.

FDA believes that the best way for a

regulatory authority to determine

whether a processor is effectively

operating a HACCP system is by

inspecting the processor to assess

whether the system is operating

properly and is appropriate for the

circumstances. Review of monitoring

and other records generated by the

HACCP system is a critical component

of an inspection because it allows the

inspector to match records against

practices and conditions being observed

in the plant and it discourages fraud.

Thus, FDA always has intended that its

review of processors’ HACCP plans and

records would occur as part of an

inspection of a processor’s entire

HACCP system.

For domestic processors, failure to

allow an inspection would not only

violate the HACCP regulations; it is also

a prohibited act under section 301(f) of

the act (21 U.S.C. 331(f)). Moreover, if

a domestic processor refuses an FDA

inspection, FDA can obtain an

inspectional warrant from the U.S.

district court in which the processor is

located.

Failure to allow an FDA inspection by

a foreign processor can also result in a

regulatory response. The definition of

‘‘processor’’ at § 123.3(l) specifically

includes persons in foreign countries.

Thus, like domestic processors, foreign

processors who ship to the United

States must operate under conditions

that satisfy FDA’s HACCP regulations,

including the requirement that records

be made available during the course of

an FDA inspection.

This draft guidance is being issued

consistent with FDA’s good guidance

practices (65 FR 56468, September 19,

2000). The draft guidance represents the

agency’s current thinking on refusal of

inspection or access to HACCP records

that pertain to the safe and sanitary

processing of fish and fishery products.

It does not create or confer any rights for

or on any person and does not operate

to bind FDA or the public. An

alternative approach may be used if

such approach satisfies the

requirements of the applicable statutes

and regulations.

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. The draft

guidance and received comments are

available for public examination in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: October 30, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–29011 Filed 11–13–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D–1020]

Medical Devices Draft Guidance on

Over the Counter (OTC) Screening

Tests for Drugs of Abuse: Guidance

for Premarket Notifications;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft guidance

entitled ‘‘Over the Counter (OTC)

Screening Tests for Drugs of Abuse:

Guidance for Premarket Notifications.’’

FDA is issuing this draft guidance to

provide information about studies and

labeling considerations applicable to

OTC screening tests that use urine as the

clinical specimen for any combination

of one or more of these drugs:

Amphetamine (and, or

methamphetamine), cocaine,

cannabinoids, opiates, and

phencyclidine. This draft guidance

defines OTC use for the purposes of this

document as use in home, workplace,

insurance, and sports settings, and

includes requests for comments on

confirmatory testing and OTC alcohol

testing. This draft guidance is neither

final nor in effect at this time.

DATES: Submit written comments on the

draft guidance by February 12, 2001.

ADDRESSES: Submit written requests for

single copies on a 3.5 ′′ diskette of the

draft guidance entitled ‘‘Over the

Counter (OTC) Screening Tests for

Drugs of Abuse: Guidance for Premarket

Notifications,’’ to the Division of Small

Manufacturers Assistance (HFZ–220),

Center for Devices and Radiological

Health, Food and Drug Administration,

1350 Piccard Dr., Rockville, MD 20850.

Send two self-addressed adhesive labels