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 

49656 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 

independent laboratories that engage in 

quality control and testing for registered 

blood product establishments.

FDA estimates the burden of this 

collection of information based upon 

information obtained from the Center 

for Biologics Evaluation and Research’s 

database and FDA experience with the 

blood establishment registration and 

product listing requirements.

FDA estimates the burden of this 

collection as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section Form FDA 2830

No. of

Respondents

Annual 

Frequency 

per

Response

Total Annual 

Responses 

Hours per 

Response 

Total 

Hours 

607.20(a), 607.21, 607.22, 607.25, and 607.40 Initial registration 100 1 100 1 100

607.21, 607.22, 607.25, 607.26, 607.31, and 

607.40

Reregistration 2,775 1 2,775 0.5 1,388

607.21, 607.25, 607.30, 607.31, and 607.40 Product listing update 180 1 180 0.25 45

Total 1,533

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

Dated: August 17, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–16847 Filed 8–23–05; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

Request for Nominations for Voting 

Members on Public Advisory Panels or 

Committees

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for voting members to 

serve on certain device panels of the 

Medical Devices Advisory Committee, 

the National Mammography Quality 

Assurance Advisory Committee, the 

Device Good Manufacturing Practice 

Advisory Committee, and the Technical 

Electronic Products Radiation Safety 

Standards Committee in the Center for 

Devices and Radiological Health. 

Nominations will be accepted for 

current vacancies and those that will or 

may occur through August 31, 2006.

FDA has a special interest in ensuring 

that women, minority groups, and 

individuals with disabilities are 

adequately represented on advisory 

committees and, therefore, encourages 

nominations of qualified candidates 

from these groups.

DATES: Because scheduled vacancies 

occur on various dates throughout each 

year, no cutoff date is established for the 

receipt of nominations. However, when 

possible, nominations should be 

received at least 6 months before the 

date of scheduled vacancies for each 

year, as indicated in this notice.

ADDRESSES: Send all nominations and 

curricula vitae to the following contact 

persons in table 1 of this document:

TABLE 1.

Contact Person Committee/Panel 

Nancy J. Pluhowski, Center for Devices and Radiological Health (HFZ–400), Food and 

Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301–594–2022, or 

e-mail: NJP@CDRH.FDA.GOV

Certain Device Panels of the Medical Devices Advisory Committee

Charles A. Finder, Center for Devices and Radiological Health (HFZ–240), Food and 

Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, e-mail: 

CAF@CDRH.FDA.GOV

National Mammography Quality Assurance Advisory 

Committee

Collin L. Figueroa, Center for Devices and Radiological Health (HFZ–342), Food and 

Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, e-mail: 

CXF@CDRH.FDA.GOV

Device Good Manufacturing Practice Advisory Committee

Richard V. Kaczmarek, Center for Devices and Radiological Health (HFZ–240), Food 

and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, e-mail: 

RVK@CDRH.FDA.GOV

Technical Electronic Product Radiation Safety 

Standards Committee

FOR FURTHER INFORMATION CONTACT:

Kathleen L. Walker, Center for Devices 

and Radiological Health (HFZ–17), Food 

and Drug Administration, 2098 Gaither 

Rd., Rockville, MD 20850, 240–276–

0450, ext. 114, e-mail: 

KLW@CDRH.FDA.GOV.

SUPPLEMENTARY INFORMATION:

I. Vacancies

FDA is requesting nominations of 

voting members for vacancies listed as 

follows: