49654 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 

announcements on the HHS/CDC Web 

site, Internet address: http://

www.cdc.gov (Click on ‘‘Funding’’ then 

‘‘Grants and Cooperative Agreements’’), 

and on the Web site of the HHS Office 

of Global Health Affairs, Internet 

address: http://www.globalhealth.gov.

Dated: August 17, 2005. 

William P. Nichols, 

Director, Procurement and Grants Office, 

Centers for Disease Control and Prevention, 

U.S. Department of Health and Human 

Services.

[FR Doc. 05–16838 Filed 8–23–05; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0442]

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Food and Drug 

Administration Recall Regulations 

(Guidelines)

AGENCY: Food and Drug Administration, 

HHS.

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.

DATES: Fax written comments on the 

collection of information by September 

23, 2005.

ADDRESSES: The Office of Management 

and Budget (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 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: Fumie Yokota, Desk Officer 

for FDA, FAX: 202–395–6974.

FOR FURTHER INFORMATION CONTACT:

Karen Nelson, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1482.

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance.

Food and Drug Administration Recall 

Regulations (Guidelines)—(OMB 

Control Number 0910–0249)—Extension

Section 701 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 371) and 

part 7 (21 CFR part 7), subpart C sets 

forth the recall regulations (guidelines) 

and provides guidance to manufacturers 

on recall responsibilities. The 

guidelines apply to all FDA-regulated 

products (i.e., food, including animal 

feed; drugs, including animal drugs; 

medical devices, including in vitro 

diagnostic products; cosmetics; and 

biological products intended for human 

use). These responsibilities include 

development of a recall strategy that 

requires time by the firm to determine 

the actions or procedures required to 

manage the recall; providing FDA with 

complete details of the recall including 

reason(s) for the removal or correction, 

risk evaluation, quantity produced, 

distribution information, firm’s recall 

strategy, a copy of any recall 

communication(s), and a contact 

official; notifying direct accounts of the 

recall, providing guidance regarding 

further distribution, giving instructions 

as to what to do with the product, 

providing recipients with a ready means 

of reporting to the recalling firm; 

submitting periodic status reports so 

that FDA may assess the progress of the 

recall. Status report information may be 

determined by, among other things 

evaluation return reply cards, 

effectiveness checks and product 

returns; and providing the opportunity 

for a firm to request in writing that FDA 

terminate the recall.

A search of the FDA database was 

performed to determine the number of 

recalls that took place during fiscal year 

2003. The resulting number of recalls 

from this database search (2,375) is used 

in estimating the current annual 

reporting burden for this report. FDA 

estimates the total annual industry 

burden to collect and provide the above 

information to 201,875 burden hours.

The following is a summary of the 

estimated annual burden hours for 

recalling firms (manufacturers, 

processors, and distributors) to comply 

with the voluntary reporting 

requirements of FDA’s recall 

regulations.

Recognizing that there may be a vast 

difference in the information collection 

and reporting time involved in different 

recalls of FDA’s regulated products, 

FDA estimates on average the burden of 

collection for recall information to be 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 

Recall Strategy 2,375 1 2,375 15 35,625

Firm Initiated Recall & Public Warnings Recall Communications 2,375 1 2,375 20 47,500

Recall Status Reports & 

Followup 2,375 4 9,500 10 95,000

Termination of a Recall 2,375 1 2,375 10 23,750

Total 201,875

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

The annual reporting burdens are 

explained as follows:

Recall Strategy

Requests firms to develop a recall 

strategy including provision for public 

warnings and effectiveness checks. 

Under this portion of the collection of 

information, the agency estimates it will 

receive 2,375 responses annually.

Firm Initiated Recall and Recall 

Communications

Requests firms that voluntarily 

remove or correct foods and drugs 

(human or animal), cosmetics, medical 

devices, and biologicals to immediately 

notify the appropriate FDA district 

office of such actions. The firm is to 

provide complete details of the recall 

reason, risk, evaluation, quantity 

produced, distribution information, 

firm’s recall strategy, and a contact 

official as well as requires firms to 

Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 49655

notify their direct accounts of the recall 

and to provide recipients with a ready 

means of reporting to the recalling firm. 

Under these portions of the collection of 

information, the agency estimates it will 

receive 2,375 responses annually for 

each.

Recall Status Reports

Requests that recalling firms provide 

periodic status reports so FDA can 

ascertain the progress of the recall. This 

collection of information will generate 

approximately 9,500 responses 

annually.

In the Federal Register of October 12, 

2004 (69 FR 60630), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. No comments were received.

Dated: August 17, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–16846 Filed 8–23–05; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N–0327]

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Blood 

Establishment Registration and 

Product Listing, Form FDA 2830

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 the blood establishment 

registration and product listing 

requirements and Form FDA 2830.

DATES: Submit written or electronic 

comments on the collection of 

information by October 24, 2005.

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 Management 

Programs (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 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 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.

Blood Establishment Registration and 

Product Listing, Form FDA 2830—21 

CFR Part 607 (OMB Control Number 

0910–0052)—Extension

Under section 510 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

360), any person owning or operating an 

establishment that manufactures, 

prepares, propagates, compounds, or 

processes a drug or device must register 

with the Secretary of Health and Human 

Services, on or before December 31 of 

each year, his or her name, place of 

business, and all such establishments 

submit, among other information, a 

listing of all drug or device products 

manufactured, prepared, propagated, 

compounded, or processed by him or 

her for commercial distribution. In part 

607 (21 CFR part 607), FDA has issued 

regulations implementing these 

requirements for manufacturers of 

human blood and blood products.

Section 607.20(a) requires certain 

establishments that engage in the 

manufacture of blood products to 

register and to submit a list of blood 

products in commercial distribution. 

Section 607.21 requires the 

establishments entering into the 

manufacturing of blood products to 

register within 5 days after beginning 

such operation and to submit a blood 

product listing at that time. In addition, 

establishments are required to register 

annually between November 15 and 

December 31 and update their blood 

product listing every June and 

December of each year. Section 607.22 

requires the use of Form FDA 2830, 

Blood Establishment Registration and 

Product Listing, for initial registration, 

for annual registration, and for blood 

product listing. Section 607.25 indicates 

the information required for 

establishment registration and blood 

product listing. Section 607.26 requires 

certain changes to be submitted as 

amendments to the establishment 

registration within 5 days of such 

changes. Section 607.30 requires 

establishments to update their blood 

product listing information every June 

and December, or at the discretion of the 

registrant at the time the change occurs. 

Section 607.31 requires that additional 

blood product listing information be 

provided upon FDA request. Section 

607.40 requires foreign blood product 

establishments to register and submit 

the blood product listing information, 

the name and address of the 

establishment, and the name of the 

individual responsible for submitting 

blood product listing information as 

well as the name, address, and phone 

number of its U.S. agent.

Among other uses, this information 

assists FDA in its inspections of 

facilities, and its collection is essential 

to the overall regulatory scheme 

designed to ensure the safety of the 

Nation’s blood supply. Form FDA 2830 

is used to collect this information.

Respondents to this collection of 

information are human blood and 

plasma donor centers, blood banks, 

certain transfusion services, other blood 

product manufacturers, and