46744 Federal Register / Vol. 62, No. 171 / Thursday, September 4, 1997 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0022]

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 October 6,

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, Attention: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Judith V. Bigelow, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1479.

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.

Agreement for Shipment of Devices for

Sterilization—21 CFR 801.150(a)(2) and

(e) (OMB Control No. 0910–0131—

Reinstatement)

Under sections 501(c) and 502(a) of

the act (21 U.S.C. 351(c) and 352(a)),

nonsterile devices that are labeled as

sterile but are in interstate transit to a

facility to be sterilized are adulterated

and misbranded. FDA regulations in

§ 801.150(a)(2) and (e) (21 CFR

801.150(a)(2) and (e)) establish a control

mechanism by which firms may

manufacture and label medical devices

as sterile at one establishment and ship

the devices in interstate commerce for

sterilization at another establishment, a

practice that facilitates the processing of

devices and is economically necessary

for some firms. Under § 801.150(a)(2)

and (e), manufacturers and sterilizers

may sign an agreement containing the

following: (1) Instructions for

maintaining accountability of the

number of units in each shipment; (2)

acknowledgment that the devices are

nonsterile, being shipped for further

processing; and (3) specifications for

sterilization processing.

This agreement allows the

manufacturer to ship nonsterile

products to be sterilized without

initiating regulatory action and provides

FDA with a means to protect consumers

from use of nonsterile products. During

routine plant inspections, FDA normally

reviews agreements that must be kept

for 2 years after final shipment or

delivery of devices. To discontinue this

reporting and recordkeeping procedure

would place an economic hardship on

the industry and an additional burden

on FDA to monitor products in

interstate commerce for failure to

comply with adulteration and

misbranding provisions of the act.

The respondents to this collection of

information are device manufacturers

and contract sterilizers.

FDA estimates the reporting burden of

this collection of information as follows:

TABLE—1. ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

801.150 90 20 1,800 4 7,200

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

No burden has been estimated for the

recordkeeping requirement in

§ 801.150(a)(2) because these records are

maintained as a usual and customary

part of normal business activities. Under

5 CFR 1320.3(b)(2), the time, effort, and

financial resources necessary to comply

with a collection of information are

excluded from the burden estimate if

the reporting, recordkeeping, or

disclosure activities needed to comply

are usual and customary because they

would occur in the normal course of

activities.

FDA’s estimate of the burden is based

on actual data obtained from industry

during the past 3 years where there are

approximately 90 firms subject to this

requirement.

Dated: August 27, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–23507 Filed 9–3–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Memorandum of Understanding

Between the Food and Drug

Administration and the Department of

Agriculture, Food and Forestry of

Ireland

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is providing

notice of a memorandum of

understanding (MOU) between FDA and

the Department of Agriculture, Food

and Forestry of Ireland. The purpose of

the MOU is to establish certification

requirements for caseins, caseinates,

and mixtures thereof.

DATES: The agreement became effective

November 5, 1996.

FOR FURTHER INFORMATION CONTACT:

Merton Smith, Office of Health Affairs

(HFY–50), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4480.

SUPPLEMENTARY INFORMATION: In

accordance with 21 CFR 20.108(c),

which states that all written agreements

and MOU’s between FDA and others

shall be published in the Federal

Register, the agency is publishing notice

of this MOU.
Federal Register / Vol. 62, No. 171 / Thursday, September 4, 1997 / Notices 46745

Dated: August 28, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

Memorandum of Understanding Between the

Food and Drug Administration Department

of Health and Human Services of the United

States of America and the Department of

Agriculture, Food and Forestry of Ireland

Covering Caseins, Caseinates, and Mixtures

Thereof Exported to the United States

I. Purpose

The Food and Drug Administration (FDA),

Department of Health and Human Services of

the United States of America and the

Department of Agriculture, Food and

Forestry (DAFF) of Ireland upon signing this

Memorandum of Understanding (MOU)

intend to:

1. Establish certification requirements for

the caseins, caseinates, and mixtures

thereof exported from Ireland to the

United States to assure that

contaminated caseins, caseinates, and

mixtures thereof will not be imported

into the United States.

2. Minimize the need for extensive FDA

audit sampling of these certified

products from Ireland.

II. Definitions

For the purposes of this MOU, both

participants concur in the following

definitions:

LOT: A lot is a quantity of casein,

caseinates, or mixtures thereof packaged by

one manufacturer during a definite period of

time not exceeding one (1) day. The

manufacturing process, including milling

and packaging, is performed by using a

perfectly identified processing line. Caseins,

caseinates, or mixtures thereof intended for

export to the United States are packaged,

after milling, in identical containers

identified by a unique code or mark traceable

to the manufacturer.

SALMONELLA-NEGATIVE: The absence of

Salmonella in thirty (30) subsamples, each of

twenty-five (25) grams, that have been taken

from the same lot of product and tested using

the procedures contained in the current

edition of the Bacteriological Analytical

Manual (see Section V. Analytical

Methodology).

PHOSPHATASE-NEGATIVE: The absence

of phosphatase activity in thirty (30)

subsamples, each of twenty-five (25) grams,

that have been taken from the same lot of

product and tested using the method

contained in the current edition of the

Official Methods of Analysis (see Section V.

Analytical Methodology).

III. Substance of MOU

A. The Department of Agriculture, Food

and Forestry of Ireland

The Department of Agriculture, Food and

Forestry of Ireland (DAFF) is the agency of

the Irish government responsible for

inspecting those caseins, caseinates, and

mixtures thereof that are intended for export.

Such inspection is necessary for consumer

protection. To fulfill its responsibilities

under this Memorandum of Understanding,

DAFF intends to ensure that caseins,

caseinates, and mixtures thereof that are

intended for export to the United States are

fit for human consumption in that they

comply with the requirements of the Food,

Drug, and Cosmetic Act of the United States,

of the Public Health Service Act of the

United States, and of this Memorandum of

Understanding. DAFF intends to inspect and

analyze samples of these caseins, caseinates,

and mixtures thereof to ensure that they

comply with these requirements.

To discharge its responsibilities regarding

caseins, caseinates, and mixtures thereof and

to fulfill its commitment under this MOU,

DAFF plans to:

1. Inspect and analyze each lot of caseins,

caseinates, and mixtures thereof

produced in Ireland for export to the

United States to assure that it is

Salmonella-negative and phosphatasenegative, based on the testing of thirty

(30) subsamples of twenty-five (25) gram

units taken from bags in a lot of caseins,

caseinates, and mixtures thereof

immediately before closing, as

determined by the methods cited in

Section V. Analytical Methodology.

2. Require that all containers of a lot of

caseins, caseinates, and mixtures thereof

that are to be exported to the United

States be certified as comply with the

provisions of this Memorandum of

Understanding, and identified by a lot

number, and all other information

required by the Federal Food, Drug, and

Cosmetic Act of the United States.

3. Require that all of the information that

is required by the Food, Drug, and

Cosmetic Act and the Fair Packaging and

Labeling Act of the United States be

included on the label and labeling of

individual products.

4. Furnish FDA with a copy of the current

Irish regulations and the procedures

used to ensure that the caseins,

caseinates, and mixtures thereof are in

compliance with those regulations and

with the Food, Drug, and Cosmetic Act

and the Public Health Service Act of the

United States.

5. Furnish FDA, upon request, with a full

description of the manufacturing

processes and quality controls used to

ensure that the caseins, caseinates, and

mixtures thereof that are produced are fit

for human consumption, as discussed in

III. A. Substance of MOU.

B. The Food and Drug Administration of

the United States of America

FDA is charged with the enforcement of

the Food, Drug, and Cosmetic Act, the Fair

Packaging and Labeling Act, certain

provisions of the Public Health Service Act,

and other related statutes of the United

States. FDA directs its activities toward the

protection of the public health in the United

States by ensuring that foods are safe and

wholesome and are honestly and

informatively labeled. FDA accomplishes this

goal in part through inspections of food

processors and distributors. In addition, it

collects and examines samples to ensure

compliance with these statutes. FDA makes

a concerted effort to ensure that foods

entering the United States meet the same

standards as domestic products. To discharge

these responsibilities regarding caseins,

caseinates, and mixtures thereof and to fulfill

this Memorandum of Understanding, FDA

plans to:

1. Audit samples of caseins, caseinates,

and mixtures thereof certified by DAFF

under this Memorandum of

Understanding to ensure that the

products exported from Ireland and

offered for import into the United States

comply with the requirements of the

Food, Drug, and Cosmetic Act, the Fair

Packaging and Labeling Act, the Public

Health Service Act, and other related

statutes of the United States.

2. Share any information obtained through

its audit sampling with DAFF and the

First Secretary of the Embassy of Ireland.

3. Promptly notify DAFF and the First

Secretary of the Embassy of Ireland of

the detention of any caseins, caseinates,

and mixtures thereof covered by this

Memorandum of Understanding.

4. Share expertise and provide consultative

assistance to DAFF when necessary to

assure the safety of the caseins,

caseinates, and mixtures thereof

exported to the United States.

IV. Sample Collection

The same samples should be used to

determine both the presence, if any, of

Salmonella and the level of phosphatase

activity.

Each sample will consist of thirty (30)

subsamples of caseins, caseinates, or

mixtures thereof. Each subsample will

consist of approximately twenty-five (25)

grams that will be collected in accordance

with the applicable portions of the current

edition of the Bacteriological Analytical

Manual (see Section V. Analytical

Methodology).

V. Analytical Methodology

Compliance with the established criteria

for Salmonella and phosphatase should be

determined according to the methods

contained in the current editions of

Bacteriological Analytical Manual for

Salmonella and Official Methods of Analysis

for phosphatase.

These publications are available from:

AOAC International

481 North Frederick Avenue, Suite 500

Gaithersburg, MD 20877

Telephone number: 301–924–7077

Telefax number: 301–924–7089

VI. Participating Parties

A. The Department of Agriculture, Food and

Forestry, Agriculture House, Kildare Street,

Dublin 2, Ireland

B. Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, USA

VII. Liaison Officers

A. For the Department of Agriculture, Food

and Forestry: Principal Officer, Milk Policy

Division, (Currently, Mr. Tom Moran),

Department of Agriculture, Food and

Forestry, Agriculture House, Kildare Street,

Dublin 2, Ireland

For the Embassy of Ireland: First Secretary,

(Currently, Ms. Kate Slattery), 2234

Massachusetts Avenue, N.W., Washington,
46746 Federal Register / Vol. 62, No. 171 / Thursday, September 4, 1997 / Notices

DC 20008. Telephone number: 202–452–

3939

B. For the Food and Drug Administration:

Director, International Activities Staff,

(Currently, Mr. Charles W. Cooper), Center

for Food Safety and Applied Nutrition,

Food and Drug Administration, 200 C

Street, S.W., Washington, DC 20204.

Telephone number: 202–205–5042, Telefax

number: 202– 205–0165

VIII. Administrative Procedures

The participants mutually consent on the

ways and means of giving instructions and

guidance for the practical implementation

and application of this Memorandum of

Understanding.

The obligations under this MOU are

intended to be non-binding.

IX. Period of MOU

Activities under this Memorandum of

Understanding commence upon signature by

both participants for a period of five (5) years

and may, at the conclusion of that period,

with the consent of both participants, be

extended for an additional five (5) years. The

participants plan to evaluate the MOU

sometime during each five (5) year period.

The MOU may be extended or revised by

mutual consent, or terminated by either

participant, upon a thirty (30) day advance

written notice to the other.

For the Department of Agriculture, Food

and Forestry of Ireland

By: K. Slattery

Title: First Secretary, Embassy of Ireland

Date: November 5, 1996

Place: Rockville, Maryland

For the Food and Drug Administration,

Department of Health and Human Services of

the United States of America

By: M. A. Friedman

Title: Deputy Commissioner for Operations,

U.S. Food and Drug Administration

Date: November 5, 1996

Place: Rockville, Maryland

[FR Doc. 97–23451 Filed 9–3–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

National Vaccine Injury Compensation

Program; List of Petitions Received

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Notice.

SUMMARY: The Health Resources and

Services Administration (HRSA) is

publishing this notice of petitions

received under the National Vaccine

Injury Compensation Program (‘‘the

Program’’), as required by section

2112(b)(2) of the Public Health Service

(PHS) Act, as amended. While the

Secretary of Health and Human Services

is named as the respondent in all

proceedings brought by the filing of

petitions for compensation under the

Program, the United States Court of

Federal Claims is charged by statute

with responsibility for considering and

acting upon the petitions.

FOR FURTHER INFORMATION CONTACT: For

information about requirements for

filing petitions, and the Program

generally, contact the Clerk, United

States Court of Federal Claims, 717

Madison Place, N.W., Washington, D.C.

20005, (202) 219–9657. For information

on HRSA’s role in the Program, contact

the Director, National Vaccine Injury

Compensation Program, 5600 Fishers

Lane, Room 8A35, Rockville, MD 20857,

(301) 443–6593.

SUPPLEMENTARY INFORMATION: The

Program provides a system of no-fault

compensation for certain individuals

who have been injured by specified

childhood vaccines. Subtitle 2 of title

XXI of the PHS Act, 42 U.S.C. 300aa–

10 et seq., provides that those seeking

compensation are to file a petition with

the U.S. Court of Federal Claims and to

serve a copy of the petition on the

Secretary of Health and Human

Services, who is named as the

respondent in each proceeding. The

Secretary has delegated her

responsibility under the Program to

HRSA. The Court is directed by statute

to appoint special masters who take

evidence, conduct hearings as

appropriate, and make initial decisions

as to eligibility for, and amount of,

compensation.

A petition may be filed with respect

to injuries, disabilities, illnesses,

conditions, and deaths resulting from

vaccines described in the Vaccine Injury

Table (the Table) set forth at section

2114 of the PHS Act or as set forth at

42 CFR 100.3, as applicable. This Table

lists for each covered childhood vaccine

the conditions which will lead to

compensation and, for each condition,

the time period for occurrence of the

first symptom or manifestation of onset

or of significant aggravation after

vaccine administration. Compensation

may also be awarded for conditions not

listed in the Table and for conditions

that are manifested after the time

periods specified in the Table, but only

if the petitioner shows that the

condition was caused by one of the

listed vaccines.

Section 2112(b)(2) of the PHS Act, 42

U.S.C. 300aa–12(b)(2), requires that the

Secretary publish in the Federal

Register a notice of each petition filed.

Set forth below is a list of petitions

received by HRSA on April 10, 1997,

through June 24, 1997.

Section 2112(b)(2) also provides that

the special master ‘‘shall afford all

interested persons an opportunity to

submit relevant, written information’’

relating to the following:

1. The existence of evidence ‘‘that

there is not a preponderance of the

evidence that the illness, disability,

injury, condition, or death described in

the petition is due to factors unrelated

to the administration of the vaccine

described in the petition,’’ and

2. Any allegation in a petition that the

petitioner either:

(a) ‘‘Sustained, or had significantly

aggravated, any illness, disability,

injury, or condition not set forth in the

Table but which was caused by’’ one of

the vaccines referred to in the Table, or

(b) ‘‘Sustained, or had significantly

aggravated, any illness, disability,

injury, or condition set forth in the

Table the first symptom or

manifestation of the onset or significant

aggravation of which did not occur

within the time period set forth in the

Table but which was caused by a

vaccine’’ referred to in the Table.

This notice will also serve as the

special master’s invitation to all

interested persons to submit written

information relevant to the issues

described above in the case of the

petitions listed below. Any person

choosing to do so should file an original

and three (3) copies of the information

with the Clerk of the U.S. Court of

Federal Claims at the address listed

above (under the heading ‘‘For Further

Information Contact’’), with a copy to

HRSA addressed to Director, Bureau of

Health Professions, 5600 Fishers Lane,

Room 8–05, Rockville, MD 20857. The

Court’s caption (Petitioner’s Name v.

Secretary of Health and Human

Services) and the docket number

assigned to the petition should be used

as the caption for the written

submission.

Chapter 35 of title 44, United States

Code, related to paperwork reduction,

does not apply to information required

for purposes of carrying out the

Program.

List of Petitions

1. Laurie Duplease on behalf of Alexis

Duplease, New Haven, Connecticut,

Court of Federal Claims Number

97–0270 V

2. James Gimesky on behalf of Jenna

Lynn Gimesky, Ann Arbor,

Michigan, Court of Federal Claims

Number 97–0280 V

3. Shari M. and John G. Lawlor on

behalf of Brooke D. Lawlor, Omaha,

Nebraska, Court of Federal Claims

Number 97–0285 V