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
66634 Federal Register / Vol. 62, No. 244 / Friday, December 19, 1997 / Notices

supplied by the Federal Government to

the recipient for the purpose of

disclosure to the public is not a

collection of information.

Dated: December 10, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–33091 Filed 12–18–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95N–0309]

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

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. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

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.

Infant Formula Requirements (21 CFR

106.100, 21 CFR 106.120(b), 21 CFR

107.10(a), 21 CFR 107.20, 21 CFR

107.50(e)(2), 21 CFR 107.50(b)(3), 21

CFR 107.50(b)(4), 21 CFR

107.50(c)(3))—(OMB Control Number

0910–0256—Extension)

Statutory requirements for infant

formula under the Federal Food, Drug,

and Cosmetic Act (the act) are intended

to protect the health of infants and

include a number of reporting and

recordkeeping requirements. Among

other things, section 412 of the act (21

U.S.C. 350a) requires manufacturers of

infant formula to establish and adhere to

quality control procedures, notify FDA

when a batch of infant formula that has

left the manufacturer’s control may be

adulterated or misbranded, and keep

records of distribution. FDA has issued

regulations to implement the act’s

requirements for infant formula in 21

CFR parts 106 and 107.

FDA also regulates the labeling of

infant formula under the authority of

section 403 (21 U.S.C. 343). Under the

labeling regulations for infant formula

in 21 CFR part 107, the label of an infant

formula must include nutrient

information and directions for use. The

purpose of these labeling requirements

is to ensure that consumers have the

information they need to prepare and

use infant formula appropriately.

In a document published in the

Federal Register of July 9, 1996 (61 FR

36154), FDA proposed changes in the

infant formula regulations, including

some of those listed below. The

document included revised burden

estimates for the proposed changes and

solicited public comment. In the

interim, however, FDA is seeking an

extension of OMB approval for the

current regulations so that it can

continue to collect information while

the proposal is pending.

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

106.120(b) 4 7 28 0 0

107.10(a) 107.20 4 7 28 8 224

107.50(b)(3), (b)(4) 3 4 12 4 48

107.50(e)(2) 3 4 12 0 0

Total 272

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

106.100 4 10 40 4,000 16,000

107.50(c)(3) 4 10 40 0 0

Total 16,000

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

In compiling these estimates, FDA

consulted its records of the number of

infant formula submissions received in

the past. The figures for hours per

response are based on estimates from

experienced persons in the agency and

in industry. Because these infant

formula regulations implement statutory

information collection requirements,

only the additional burden attributable

to the regulations has been included in

the estimates.

Due to clerical error, the burden

estimates that appeared in FDA’s

previous notice soliciting comments on

this collection of information (62 FR

42256, August 6, 1997) were incorrect.

The tables above contain the correct

estimates.