66632 Federal Register / Vol. 62, No. 244 / Friday, December 19, 1997 / Notices

Committee name Code

Vaccines and Related Biological Products Advisory Committee .................................................................... 12391

Transmissible Spongiform Encephalopathies Advisory Committee ................................................................ 12392

Dated: December 11, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–33097 Filed 12–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0503]

Agency Information Collection

Activities: Proposed Collection

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

requirements for submission of a new

animal drug application (NADA).

DATES: Submit written comments on the

collection of information by February

17, 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,

301–827–1686.

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.

New Animal Drug Application (NADA),

Form FDA 356 V, 21 CFR Part 514,

(OMB Control number 0910–0032—

Reinstatement)

Description: FDA has the

responsibility under the Federal Food,

Drug, and Cosmetic Act (the act), for the

approval of new animal drugs that are

safe and effective. Section 512(b) of the

act (21 U.S.C. 360b(b)) requires that a

sponsor submit and receive approval of

a NADA, before interstate marketing is

allowed. The regulations implementing

statutory requirements for NADA

approval have been codified under 21

CFR part 514. NADA applicants

generally use a single form, FDA 356 V.

The NADA must contain, among other

things, safety and effectiveness data for

the drug, labeling, a list of components,

manufacturing and controls

information, and complete information

on any methods used to determine

residues of drug chemicals in edible

tissues. While the NADA is pending, an

amended application may be submitted

for proposed changes. After an NADA

has been approved, a supplemental

application must be submitted for

certain proposed changes, including

changes beyond the variations provided

for in the NADA and other labeling

changes. An amended application and a

supplemental application may omit

statements concerning which no change

is proposed. This information is

reviewed by FDA scientific personnel to

ensure that the intended use of an

animal drug, whether as a

pharmaceutical dosage form, in drinking

water, or in medicated feed, is safe and

effective. The respondents are

pharmaceutical firms that produce

veterinary products and commercial

feed mills.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Form No. 21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Form FDA 356 V 514.1 and 514.6 190 6.76 1,824 211.6 271,694

514.8 and 514.9 30 8,520

514.11 1 1,824

Total burden hours 282,038

1There are no capital costs or operating and maintenance costs associated with this collection of information.
Federal Register / Vol. 62, No. 244 / Friday, December 19, 1997 / Notices 66633

The estimate of the burden hours

required for reporting are based on fiscal

year 1996 data. The burden estimate

includes original NADA‘s, supplemental

NADA‘s and amendents to unapproved

applications.

Dated: December 10, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33098 Filed 12–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0485]

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 January 20,

1998.

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:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

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.

Shipment of a Blood Product Prior to

Completion of Testing for Hepatitis B

Surface Antigen (HbsAg) (21 CFR

610.40(b)); and Shipment of Blood

Products Known Reactive for HbsAg (21

CFR 610.40(d))—(OMB Control Number

0910–0168—Reinstatement)

Under sections 351 and 361 of the

Public Health Service Act (42 U.S.C. 262

and 42 U.S.C. 264), FDA prescribes

standards designed to ensure the safety,

purity, potency, and effectiveness of

biological products including blood and

blood components and to prevent the

transmission of communicable diseases.

To accomplish this, FDA requires,

among other things, that each unit of

Whole Blood or Source Plasma be tested

by a licensed serologic test for hepatitis

B surface antigen (HbsAg). Section

610.40(b)(4) (21 CFR 610.40(b)(4))

permits preapproved or emergency

shipments of blood products for further

manufacturing before the test for HbsAg

is completed. To obtain approval for

such shipments, the collection facility

must submit a description of the control

procedures to be used by the collection

facility and manufacturer. Proper

control procedures are essential to

ensure the safe shipment, handling,

quarantine of untested or incompletely

tested blood products, communication

of test results, and appropriate use or

disposal of the blood products based on

the test results. Section 610.40(d)(1) and

(d)(2) requires that a collection facility

notify FDA of each shipment of HbsAg

reactive source blood, plasma, or serum

for manufacturing into hepatitis B

vaccine and licensed or unlicensed in

vitro diagnostic biological products,

including clinical chemistry control

reagents. The reporting requirements

inform FDA of the shipment of

potentially infectious biological

products that may be capable of

transmitting disease. The respondent’s

for this information collection are the

blood collection facilities that are

shipping hepatitis B reactive products.

FDA’s monitoring of such activity is

essential should any deviations occur

that may require immediate corrective

action to protect public safety. The

labeling helps ensure that product is

safely and appropriately handled and

used by the collection facility, shipper,

and manufacturer.

Only a few firms are actually engaged

in shipping hepatitis B reactive

products and making the reports

required by § 610.40. Also, there are

very few to no emergency shipments per

year related to further manufacturing

and the only product currently shipped

prior to completion of hepatitis B testing

is a licensed product, Source

Leukocytes. Shipments of Source

Leukocytes are preapproved under the

product license applications and do not

require notification for each shipment.

Currently, there have been no

respondents reporting emergency or

preapproved shipments (§ 610.40(b)).

However, FDA is listing one report per

year for emergency or preapproved

shipments to account for the possibility

of future emergency shipments.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

610.40(b)2 1 1 1 0.5 0.5

610.40(d)3 6 8.5 51 0.5 25.5

TOTAL 26

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

2This notice involves a brief letter and an enclosure. The letter identifies who is making the shipment, to whom shipped, the nature of the

emergency, the kind and quantity shipped, and date of shipment. The enclosure is a copy of the shippers written standard operating procedures

for handling, labeling storage, and shipment of contaminated (contagious) product. The burden for development and maintenance of standard operating procedures is approved under OMB No. 0910–0116. Preparation of the notice and duplication of standard operating procedure documents is estimated at one half hour per notice. 3The notice of reactive product shipment is limited to information on: the identity of the kind and amount of source material shipped; the name

and address of the consignee; the date of shipment; and the manner in which the source material is labeled.

FDA has calculated no additional

burden in this information collection

package for the labeling requirements in

§ 610.40(d) because the information and

statements on the label necessary for

public disclosure and safety are

provided by FDA in these regulations.

Under 5 CFR 1320.3(c)(2), the public

disclosure of information originally