564 Federal Register / Vol. 63, No. 3 / Tuesday, January 6, 1998 / Notices

Board of Governors of the Federal Reserve

System, December 31, 1997.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 98–236 Filed 1–5–98; 8:45 am]

BILLING CODE 6210-01-F

FEDERAL RESERVE SYSTEM

Sunshine Act Meeting

AGENCY HOLDING THE MEETING: Board of

Governors of the Federal Reserve

System.

TIME AND DATE: 11:00 a.m., Monday,

January 12, 1998.

PLACE: Marriner S. Eccles Federal

Reserve Board Building, 20th and C

Streets, N.W., Washington, D.C. 20551.

STATUS: Closed.

MATTERS TO BE CONSIDERED:

1. Personnel actions (appointments,

promotions, assignments,

reassignments, and salary actions)

involving individual Federal Reserve

System employees.

2. Any items carried forward from a

previously announced meeting.

CONTACT PERSON FOR MORE INFORMATION:

Joseph R. Coyne, Assistant to the Board;

202–452–3204.

SUPPLEMENTARY INFORMATION: You may

call 202–452–3206 beginning at

approximately 5 p.m. two business days

before the meeting for a recorded

announcement of bank and bank

holding company applications

scheduled for the meeting; or you may

contact the Board’s Web site at http://

www.bog.frb.fed.us for an electronic

announcement that not only lists

applications, but also indicates

procedural and other information about

the meeting.

Dated: January 2, 1998.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 98–376 Filed 1–2–98; 2:49 pm]

BILLING CODE 6210–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0515]

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 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

reinstatement 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 recordkeeping requirements for

manufacturers of Type A medicated

articles.

DATES: Submit written comments on the

collection of information by March 9,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. All comments

should be identified with the docket

number found in brackets in the

heading of this document.

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,

including each proposed reinstatement

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 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;

(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.

Current Good Manufacturing Practice

Regulations for Type A Medicated

Articles—(21 CFR 226)—(OMB Control

Number 0910–0154—Reinstatement)

Under section 501 of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 351), FDA has the statutory

authority to issue current good

manufacturing practice (CGMP)

regulations for drugs, including Type A

medicated articles. A Type A medicated

article is a feed product containing a

concentrated drug diluted with a feed

carrier substance. A Type A medicated

article is intended solely for use in the

manufacture of another Type A

medicated article or a Type B or Type

C medicated feed. Medicated feeds are

administered to animals for the

prevention, cure, mitigation, or

treatment of disease or for growth

promotion and feed efficiency.

Statutory requirements for CGMP’s for

Type A medicated articles have been

codified in part 226 (21 CFR part 226).

Type A medicated articles which are not

manufactured in accordance with these

regulations are considered adulterated

under section 501(a)(2)(B) of the act.

Under part 226, a manufacturer is

required to establish, maintain, and

retain records for Type A medicated

articles, including records to document

procedures required under the

manufacturing process to ensure that

proper quality control is maintained.

Such records would, for example,

contain information concerning receipt

and inventory of drug components,

batch production, laboratory assay

results (i.e., batch and stability testing),

and product distribution. This

information is needed so that FDA can

monitor drug usage and possible

misformulation of Type A medicated

articles. The information could also

prove useful to FDA in investigating

product defects when a drug is recalled.

In addition, FDA will use the CGMP

criteria in part 226 to determine

whether or not the systems used by

manufacturers of Type A medicated

articles are adequate to ensure that their

medicated articles meet the

requirements of the act as to safety and

also meet the articles, claimed identity,

strength, quality and purity, as required

by section 501(a)(2)(B) of the act.
Federal Register / Vol. 63, No. 3 / Tuesday, January 6, 1998 / Notices 565

The respondents for Type A

medicated articles are pharmaceutical

firms that manufacture human and

veterinary drugs, veterinary drugs, and

commercial feed mills.

FDA estimate the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

226.42 200 120 24,000 0.75 18,000

226.58 200 120 24,000 1.75 42,000

226.80 200 120 24,000 0.75 18,000

226.102 200 120 24,000 1.75 42,000

226.110 200 120 24,000 0.25 6,000

226.115 200 120 24,000 1.00 24,000

Total burden hours 150,000

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimate of the times required for

record preparation and maintenance is

based on agency communications with

industry. Other information needed to

calculate the total burden hours (i.e.,

manufacturing sites, number of Type A

medicated articles being manufactured,

etc.) are derived from agency records

and experience.

Dated: December 23, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–151 Filed 1–5–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0520]

Abbott Laboratories, Premarket

Approval of IMx Tacrolimus II Assay

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application submitted

by Abbott Laboratories, Abbott Park, IL,

for premarket approval, under the

Federal Food, Drug, and Cosmetic Act

(the act), of the IMx Tacrolimus II

Assay. FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of August 26, 1997,

of the approval of the application.

DATES: Petitions for administrative

review by February 5, 1998.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Steven I. Gutman, Center for Devices

and Radiological Health (HFZ–440),

Food and Drug Administration, –2098

Gaither Rd., Rockville, MD 20850, 301–

594–1243.

SUPPLEMENTARY INFORMATION: On

February 18, 1997, Abbott Laboratories,

Abbott Park, IL 60064–3537, submitted

to CDRH an application for premarket

approval of the IMx Tacrolimus II

Assay. The device is an in vitro reagent

system for the quantitative

determination of tacrolimus and some

metabolites in human whole blood as an

aid in the management of liver allograft

patients receiving tacrolimus therapy.

In accordance with the provisions of

section 515(c)(2) of the act (21 U.S.C.

360e(c)(2)) as amended by the Safe

Medical Devices Act of 1990, this

premarket approval application (PMA)

was not referred to the Clinical

Chemistry and Toxicology Devices

Panel of the Medical Devices Advisory

Committee, an FDA advisory committee,

for review and recommendation because

the information in the PMA

substantially duplicates information

previously reviewed by this panel.

On August 26, 1997, CDRH approved

the application by a letter to the

applicant from the Deputy Director,

Clinical and Review Policy, the Office of

Device Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act authorizes

any interested person to petition, under

section 515(g) of the act, for

administrative review of CDRH’s

decision to approve this application. A

petitioner may request either a formal

hearing under 21 CFR part 12 of FDA’s

administrative practices and procedures

regulations or a review of the

application and CDRH’s action by an

independent advisory committee of

experts. A petition is to be in the form

of a petition for reconsideration under

21 CFR 10.33(b). A petitioner shall

identify the form of review requested

(hearing or independent advisory

committee) and shall submit with the

petition supporting data and

information showing that there is a

genuine and substantial issue of

material fact for resolution through

administrative review. After reviewing

the petition, FDA will decide whether to

grant or deny the petition and will

publish a notice of its decision in the

Federal Register. If FDA grants the

petition, the notice will state the issue

to be reviewed, the form of review to be

used, the persons who may participate

in the review, the time and place where

the review will occur, and other details.

Petitioners may, at any time on or

before February 5, 1998, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the