57612 Federal Register / Vol. 65, No. 186 / Monday, September 25, 2000 / Notices

Centers for Disease Control and

Prevention and the Agency for Toxic

Substances and Disease Registry.

Dated: September 20, 2000.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention.

[FR Doc. 00–24622 Filed 9–22–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1502]

Agency Information Collection

Activities: Proposed Collection;

Comment Request; Adverse

Experience Reporting for Licensed

Biological Products; and General

Records

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

extension 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 information collection requirements

relating to FDA’s adverse experience

reporting (AER) for licensed biological

products, and general records associated

with the manufacture and distribution

of biological products.

DATES: Submit written or electronic

comments on the collection of

information by November 24, 2000.

ADDRESSES: Submit electronic

comments on the collection of

information via the Internet at: http://

www.accessdata.fda.gov/scripts/oc/

dockets/comments/commentdocket.cfm.

Submit written comments on the

collection of information to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

All documents should be identified

with the docket number found in

brackets in the heading of this

document.

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: 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 request

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 extension 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 set forth in this document.

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.

Adverse Experience Reporting for

Licensed Biological Products; and

General Records—21 CFR 600.12 and

Part 600 Subpart D (OMB Control

Number 0910–0308)—Extension

Under the Public Health Service Act

(42 U.S.C. 262), FDA is required to

ensure the marketing of only those

biological products which are safe and

effective. FDA must therefore be

informed of all adverse experiences

occasioned by the use of licensed

biological products. FDA issued the

adverse experience reporting

requirements to enable FDA to take

actions necessary for the protection of

the public health in response to reports

of adverse experiences related to

licensed biological products. The

primary purpose of FDA’s adverse

experience reporting system is to flag

potentially serious safety problems with

licensed biological products, focusing

especially on newly licensed products.

Although premarket testing discloses a

general safety profile of a new drug’s

comparatively common adverse effects,

the larger and more diverse patient

populations exposed to the licensed

biological product provides the

opportunity to collect information on

rare, latent, and long-term effects.

Reports are obtained from a variety of

sources, including patients, physicians,

foreign regulatory agencies, and clinical

investigators. Information derived from

the adverse experience reporting system

contributes directly to increased public

health protection because such

information enables FDA to recommend

important changes to the product’s

labeling (such as adding a new

warning), to initiate removal of a

biological product from the market

when necessary, and to assure the

manufacturer has taken adequate

corrective action if necessary.

Section 600.80(c)(1) (21 CFR

600.80(c)(1)), requires the licensed

manufacturer to report each adverse

experience that is both serious and

unexpected, regardless of source, as

soon as possible but in any case within

15 working days of initial receipt of the

information. Section 600.80(e) requires

licensed manufacturers to submit a 15-

day alert report obtained from a

postmarketing clinical study only if

there is a reasonable possibility that the

product caused the adverse experience.

Section 600.80(c)(2) requires the

licensed manufacturer to report each

adverse experience not reported under

paragraph (c)(1) at quarterly intervals,

for 3 years from the date of issuance of

the product license, and then at annual

intervals. The majority of the periodic

reports will be submitted annually since

a large percentage of the current

licensed biological products have been

licensed longer than 3 years. Section

600.80(i) requires the licensed

manufacturer to maintain for a period of

10 years records of all adverse

experiences known to the licensed

manufacturer, including raw data and

any correspondence relating to the

adverse experiences. Section 600.81 (21

CFR 600.81) requires the licensed

manufacturer to submit information

about the quantity of the product

distributed under the product license,

including the quantity distributed to

distributors at an interval of every 6

months. The semiannual distribution

report informs FDA of the quantity, the

lot number, and the dosage of different

products. Section 600.90 (21 CFR

Federal Register / Vol. 65, No. 186 / Monday, September 25, 2000 / Notices 57613

600.90) requires a licensed

manufacturer to submit a waiver request

with supporting documentation when

asking for waiving the requirement that

applies to them under §§ 600.80 and

600.81.

Manufacturers of biological products

for human use must keep records of

each step in the manufacture and

distribution of products including

recalls of the product. The

recordkeeping requirements serve

preventative and remedial purposes.

These requirements establish

accountability and traceability in the

manufacture and distribution of

products, and enable FDA to perform

meaningful inspections.

Section 600.12 (21 CFR 600.12)

requires that all records of each step in

the manufacture and distribution of a

product be made and retained for no

less than 5 years after the records of

manufacture have been completed or 6

months after the latest expiration date

for the individual product, whichever

represents a later date. In addition,

records of sterilization of equipment

and supplies, animal necropsy records,

and records in cases of divided

manufacturing of a product are required

to be maintained. Section 600.12(b)(2)

requires complete records to be

maintained pertaining to the recall from

distribution of any product.

Respondents to this information

collection are manufacturers of

biological products. In fiscal year (FY)

99 there were approximately 79 licensed

manufacturers. This number excludes

those manufacturers who produce blood

and blood components and in-vitro

diagnostic licensed products because

they are specifically exempt from the

regulations. However, not all

manufacturers may have any

submissions in a given year and some

may have multiple submissions. FDA

received four waiver requests under

§ 600.90, of which one was approved for

exemption of the AER requirements. In

FY 99, there were an estimated 3,662

15-day alert reports, 13,238 periodic

reports, and 502 distribution reports

submitted to FDA. The number of 15-

day alert reports for postmarketing

studies as stated in § 600.80(e) was

minimal and is included in the total

number of 15-day alert reports. The

hours per response are based on FDA

experience. The burden hours required

to complete the MedWatch Form for

§ 600.80(c)(1), (e), and (f) are reported

under OMB Control No. 0910–0291.

FDA estimates the burden of this

information collection as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR section Number of

respondents

Annual

frequency per

response

Total annual

responses

Hours per

response Total hours

600.80(c)(1) and (e) 78 46.95 3,662 1 3,662

600.80(c)(2) 78 169.72 13,238 1 13,238

600.81 78 6.44 502 1 502

600.90 4 1 4 1 4

Total 17,407

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

There are approximately 343 licensed

manufacturers of biological products.

However, the number of recordkeepers

listed for § 600.12(a) through (e)

excluding paragraph (b)(2) is estimated

to be 111. This number excludes

manufacturers of blood and blood

components, because their burden hours

for recordkeeping have been reported

under § 606.160 in OMB Control No.

0910–0116. The recordkeeping burden

is based on the number of lots released

(6,446), the number of recalls made

(1,176) and the total number of AER

reports received (16,900) for FY 99. The

hours per record are based on FDA

experience.

FDA estimates the burden of this

recordkeeping as follows:

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR section Number of

recordkeepers

Annual

frequency of

recordkeeping

Total annual

records

Hours per

record Total hours

600.12 111 58.1 6,446 32 206,272

600.12(b)(2) 343 3.4 1,176 24 28,224

600.80(i) 79 213.92 16,900 1 16,900

Total 251,396

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

57614 Federal Register / Vol. 65, No. 186 / Monday, September 25, 2000 / Notices

Dated: September 19, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–24477 Filed 9–22–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0472]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Petition for

Administrative Stay of Action

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

extension 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 filing a petition for

administrative stay of action.

DATES: Submit written or electronic

comments on the collection of

information by November 24, 2000.

ADDRESSES: Submit electronic

comments on the collection of

information to http://

www.accessdata.fda.gov/scripts/oc/

dockets/edockethome.cfm. Submit

written comments on the collection of

information to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. All

comments should be identified with the

docket number found in brackets in the

heading of this document.

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: Under the

PRA (44 U.S.C. 3501093520), 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 extension 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 set forth in this document.

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.

Petition for Administrative Stay of

Action—21 CFR 10.35 (OMB Control

Number 0910–0194)—Reinstatement)—

Extension

The regulations in 21 CFR 10.35,

issued under the authority of section

701(a) of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 371(a)), set

forth the format and procedures by

which an interested person may file a

petition for an administrative stay of

action.

Respondents to this information

collection are interested persons who

choose to file a petition for an

administrative stay of action. Such a

petition must: (1) Identify the decision

involved; (2) state the action requested,

including the length of time for which

a stay is requested; and (3) include a

statement of the factual and legal

grounds on which the interested person

relies in seeking the stay. The

information provided in the petition is

used by the agency to determine

whether the requested stay should be

granted.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section No. of

respondents

Annual

frequency per

response

Total annual

responses

Hours per

response Total hours

10.35 .................................................................................... 13 1 13 10 130

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