Federal Register / Vol. 69, No. 212 / Wednesday, November 3, 2004 / Notices 64069

report to FDA. The annual report shall 

include the names and qualifications of 

the members of, and of any consultants 

used by, the Radioactive Drug Research 

Committee, using FDA Form 2914, and 

a summary of each study conducted 

during the proceeding year, using FDA 

Form 2915.

Under § 361.1(d)(5), each investigator 

shall obtain the proper consent required 

under the regulations. Each female 

research subject of childbearing 

potential must state in writing that she 

is not pregnant, or on the basis of a 

pregnancy test be confirmed as not 

pregnant.

Under § 361.1(d)(8), the investigator 

shall immediately report to the 

Radioactive Drug Research Committee 

all adverse effects associated with use of 

the drug, and the committee shall then 

report to FDA all adverse reactions 

probably attributed to the use of the 

radioactive drug.

Section 361.1(f) sets forth labeling 

requirements for radioactive drugs. 

These requirements are not in the 

reporting burden estimate because they 

are information supplied by the Federal 

Government to the recipient for the 

purposes of disclosure to the public (5 

CFR 1320.3(c)(2)).

Types of research studies not 

permitted under this regulation are also 

specified, and include those intended 

for immediate therapeutic, diagnostic, 

or similar purposes or to determine the 

safety and effectiveness of the drug in 

humans for such purposes (i.e., to carry 

out a clinical trial). These studies 

require filing of an investigational new 

drug application (IND) under 21 CFR 

312.1, and the associated information 

collections are covered in OMB 

approval number 0910–0014.

The primary purpose of this 

collection of information is to determine 

if the research studies are being 

conducted in accordance with required 

regulations. If these studies were not 

reviewed, human subjects could be 

subjected to inappropriate radiation 

and/or safety risks. Respondents to this 

information collection are the 

chairperson(s) of each individual 

Radioactive Drug Research Committee, 

investigators, and participants in the 

studies.

The source of the burden estimates 

was a phone survey of three 

chairpersons who were selected from 

Radioactive Drug Research Committees 

of different geographical areas and of 

varying levels of activity. These 

chairpersons were asked for their 

assessment of time expended, cost, and 

views on completing the necessary 

reporting forms.

FDA estimates the burden of this 

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section Forms 

No. of

Respondents

Annual Frequency per Response Total Annual

Responses

Hours per

Response Total Hours 

361.1(c)(3) FDA 2914 80 1 80 1 80

361.1(c)(3) FDA 2915 50 6.8 340 3.5 1,190

361.1(d)(8) 50 6.8 340 0.1 34

Total 1,304

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 Forms No. of Recordkeepers 

Annual Frequency 

per Recordkeeping 

Hours per Recordkeeper Total Hours 

361.1(c)(2) 80 1 per qtr=

4 per yr

10 800

361.1(d)(5) 50 6.8 0.75 38

Total 838

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

In the Federal Register of July 23, 

2004 (69 FR 44037), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. No comments were received.

Dated: October 27, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24444 Filed 11–2–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0469]

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 

64070 Federal Register / Vol. 69, No. 212 / Wednesday, November 3, 2004 / Notices 

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 January 3, 2004.

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://www.fda.gov/

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (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:

Jonna 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 these topics: (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 Part 600 

(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 

AER requirements in part 600 (21 CFR 

part 600) 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 AER 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 biological 

product’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.

The regulation in § 600.80(c)(1) 

requires the licensed manufacturer to 

report each adverse experience that is 

both serious and unexpected, whether 

foreign or domestic, as soon as possible 

but in no case later than 15 calendar 

days of initial receipt of the information 

by the licensed manufacturer and to 

submit any follow-up reports within 15 

calendar days of receipt of new 

information or as requested by FDA. 

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)(i) at quarterly intervals, 

for 3 years from the date of issuance of 

the biologics 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 

requires the licensed manufacturer to 

submit information about the quantity 

of the product distributed under the 

biologics license, including the quantity 

distributed to distributors at an interval 

of every 6 months. The semiannual 

distribution report informs FDA of the 

quantity, certain lot numbers, labeled 

date of expiration, the number of doses, 

and date of release. Under § 600.90, a 

licensed manufacturer may submit a 

waiver request that applies to the 

licensed manufacturer under §§ 600.80 

and 600.81. A waiver request submitted 

under § 600.90 must be submitted with 

supporting documentation.

Manufacturers of biological products 

for human use must keep records of 

each step in the manufacture and 

distribution of products including the 

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 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 collection of 

information are manufacturers of 

biological products. In table 1 of this 

document, the number of respondents is 

based on the estimated number of 

manufacturers that submitted the 

required information to FDA in fiscal 

year (FY) 2002 and 2003. Based on 

information obtained from the Center 

for Biologics Evaluation and Research’s 

Federal Register / Vol. 69, No. 212 / Wednesday, November 3, 2004 / Notices 64071

(CBER’s) database system, there were 90 

licensed biologics manufacturers. This 

number excludes those manufacturers 

who produce blood and blood 

components and in-vitro diagnostic 

licensed products because these 

products are specifically exempt from 

the regulations under § 600.80(k). The 

total annual responses are based on the 

average estimated number of 

submissions received annually by FDA 

for FY 2002 and 2003. However, not all 

manufacturers have submissions in a 

given year and some may have multiple 

submissions. There were an estimated 

15,126 15-day alert reports, 6,550 

periodic reports, and 323 lot 

distribution reports submitted to FDA. 

The number of 15-day alert report for 

postmarketing studies under § 600.80(e) 

is included in the total number of 15-

day alert reports. FDA received an 

average of 5 waiver requests for FY 2002 

and 2003 under § 600.90, all of which 

were approved for exemption of the 

AER requirements. The hours per 

response are based on FDA’s 

experience. The burden hours required 

to complete the MedWatch Form for 

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

under OMB control number 0910–0291.

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 

600.80(c)(1) and 

600.80(e) 90 168.07 15,126 1 15,126

600.80(c)(2) 90 72.78 6,550 28 183,400

600.81 90 3.59 323 1 355

600.90 5 1 5 1 5

Total 198,886

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

In table 2 of this document, the 

number of respondents is based on the 

number of manufacturers subject to 

those regulations. Based on information 

obtained from CBER’s database system, 

there were 320 licensed manufacturers 

of biological products in FY 2002 and 

2003. However, the number of 

recordkeepers listed for § 600.12(a) 

through (e) excluding paragraph (b)(2) is 

estimated to be 116. This number 

excludes manufacturers of blood and 

blood components because their burden 

hours for recordkeeping have been 

reported under § 606.160 in OMB 

control number 0910–0116. The total 

annual records is based on the annual 

average of lots released (6,630), number 

of recalls made (1,958), and total 

number of AER reports received 

(35,484) in FY 2002 and 2003. The 

hours per record are based on FDA’s 

experience.

FDA estimates the burden of this 

recordkeeping as follows:

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records Hours per Response Total Hours 

600.12 116 57.16 6,630 32 212,160

600.12(b)(2) 320 6.12 1,958 24 46,992

600.80(i) 90 394.27 35,484 1 35,484

Total 294,636

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

Dated: October 27, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24445 Filed 11–2–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0179]

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; New Animal Drug 

Application, Form FDA 356 V

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information 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: Fax written comments on the 

collection of information by December 

3, 2004.

ADDRESSES: OMB is still experiencing 

significant delays in the regular mail, 

including first class and express mail, 

and messenger deliveries are not being 

accepted. To ensure that comments on 

the information collection are received, 

OMB recommends that written