71444 Federal Register / Vol. 75, No. 225 / Tuesday, November 23, 2010 / Notices 

Health and Human Services approved 

for the Committee charter to be 

renewed. The new charter was effected 

and filed with the appropriate 

Congressional offices and Library of 

Congress on October 1, 2010. Renewal 

of the SACHRP charter provides 

authorization for the Committee to 

operate until October 1, 2012. 

A copy of the Committee charter is 

available on the SACHRP Web site at 

http://www.hhs.gov/ohrp/sachrp/ 

charter.htm. A copy of the Committee 

charter also can be obtained by 

accessing the FACA database that is 

maintained by the Committee 

Management Secretariat under the 

General Services Administration. The 

Web site address for the FACA database 

is http://fido.gov/facadatabase. 

Dated: November 16, 2010. 

Jerry Menikoff, 

Director, Office for Human Research 

Protections, and Executive Secretary, 

Secretary’s Advisory Committee on Human 

Research Protections. 

[FR Doc. 2010–29517 Filed 11–22–10; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Renewal of Charter for the Advisory 

Committee on Blood Safety and 

Availability 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, as amended (5 

U.S.C. App), the U.S. Department of 

Health and Human Services is hereby 

announcing renewal of the charter for 

the Advisory Committee on Blood 

Safety and Availability (ACBSA). 

FOR FURTHER INFORMATION CONTACT: Jerry 

Holmberg, PhD; Senior Advisor for 

Blood Policy and Executive Secretary, 

Advisory Committee on Blood Safety 

and Availability; Department of Health 

and Human Services; 1101 Wootton 

Parkway; Tower Building, Suite 250; 

Rockville, MD 20852; Telephone: (240) 

453–8803; Fax: (240) 453–8456; E-mail 

address: acbsa@hhs.gov. 

SUPPLEMENTARY INFORMATION: ACBSA 

was established in 1996. The Committee 

provides advice and guidance to the 

Secretary, through the Assistant 

Secretary for Health, on a range of blood 

safety issues that encompass broad 

public health and societal implications 

that cannot be resolved through analysis 

of scientific data alone. The range of 

issues on which the Committee is tasked 

to provide advice and guidance 

includes, but is not limited to: (1) 

Definition of public health parameters 

around safety and availability of the 

blood and blood products; (2) broad 

public health, ethical, and legal issues 

related to transfusion and 

transplantation safety; and (3) 

implications for safety and availability 

of various economic factors affecting 

product cost and supply. 

Since the ACBSA was established, 

renewal of the Committee charter has 

been carried out at the appropriate 

intervals as stipulated by FACA. The 

previous Committee charter was 

scheduled to expire on October 9, 2010. 

On October 8, 2010, the Secretary of 

Health and Human Services approved 

for the Committee charter to be 

renewed. The new charter was effected 

and filed with the appropriate 

Congressional offices and Library of 

Congress on October 9, 2010. Renewal 

of the ACBSA charter provides 

authorization for the Committee to 

operate until October 9, 2012. 

A copy of the Committee charter is 

available on the ACBSA Web site at 

http://www.hhs.gov/ash/bloodsafety/. A 

copy of the Committee charter also can 

be obtained by accessing the FACA 

database that is maintained by the 

Committee Management Secretariat 

under the General Services 

Administration. The Web site address 

for the FACA database is http://fido.gov/ 

facadatabase. 

Dated: November 17, 2010. 

Jerry A. Holmberg, 

Senior Advisor for Blood Policy, Executive 

Secretary, Advisory Committee on Blood 

Safety and Availability. 

[FR Doc. 2010–29518 Filed 11–22–10; 8:45 am] 

BILLING CODE 4150–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0422] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Information From 

United States Firms and Processors 

That Export to the European 

Community 

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 December 

23, 2010. 

ADDRESSES: 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: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0320. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

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. 

Information From United States Firms 

and Processors That Export to the 

European Community (OMB Control 

Number 0910–0320)—Revision 

The European Community (EC) is a 

group of 27 European countries that 

have agreed to harmonize their 

commodity requirements to facilitate 

commerce among member States. EC 

legislation for intra-EC trade has been 

extended to trade with non-EC 

countries, including the United States. 

For certain food products, including 

those listed in this document, EC 

legislation requires assurances from the 

responsible authority of the country of 

origin that the processor of the food is 

in compliance with applicable 

regulatory requirements. The European 

Commission, the executive branch of 

the EC, requires countries trading with 

any of the EC member countries to 

provide lists of firms and processors 

approved to export certain animalderived commodities to the EC. As 

stated in the notice published in the 

Federal Register of April 4, 1996 (61 FR 

15077), FDA established a list of U.S. 

firms and processors that intended to 

export shell eggs, dairy products, and 

game meat and game meat products to 

the EC. 

Although the 1996 Federal Register 

notice did not include on the list firms 

and processors exporting raw, bulk 

collagen, and gelatin intended for 

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Federal Register / Vol. 75, No. 225 / Tuesday, November 23, 2010 / Notices 71445 

human consumption, EC directives 

require that shipments of raw, bulk 

collagen, and gelatin products be 

accompanied by certification stating 

that the product, derived from ruminant 

bones, bovine hides, and pigskins, has 

been produced in compliance with EC 

Council Directive 2003/863/EC. The 

directive contains the requirements for 

sourcing, manufacture, transport, and 

storage of raw materials and 

manufacture of finished products. 

Chapter III, Article 23, of the directive 

requires lists identifying non-EC firms 

and processors that meet EC 

requirements and have the appropriate 

animal and public health certificates. 

Therefore, FDA is revising this 

information collection in order to 

facilitate exports of raw, bulk collagen, 

and gelatin originating from the United 

States into the EC. The description of 

the data elements to be collected from 

firms and processors of raw, bulk 

collagen, and gelatin products follows. 

The estimated burden hours associated 

with this information collection remain 

37 total hours. FDA requests the 

following information from each firm or 

processor seeking to be included on the 

lists for shell eggs, dairy products, game 

meat, game meat products, and animal 

casings: 

• Business name and address; 

• Name and telephone number of 

person designated as business contact; 

• Lists of products presently being 

shipped to the EC and those intended to 

be shipped in the next 6 months; 

• Name and address of manufacturing 

plants for each product; and 

• Names and affiliations of any 

Federal, State, or local governmental 

agencies that inspect the plant, 

government-assigned plant identifier 

such as plant number, and last date of 

inspection. 

FDA uses the information to maintain 

lists of firms and processors that have 

demonstrated current compliance with 

U.S. requirements and provides the lists 

to the EC quarterly. Inclusion on the list 

is voluntary. EC member countries refer 

to the lists at ports of entry to verify that 

products offered for importation to the 

EC from the United States are from firms 

and processors that meet U.S. regulatory 

requirements. Products processed by 

firms and processors not on the lists are 

subject to detention and possible refusal 

at the port. 

FDA requests the following 

information from each firm or processor 

seeking to be included on the lists for 

raw, bulk collagen, and gelatin: 

• Business name and address; 

• Name, telephone number, and 

email address of contact person; 

• List of products presently shipped 

to the EC and those intended to be 

shipped within the next 2 years; 

• Name and address of the 

manufacturing and processing plant for 

each product; 

• Names and affiliations of any 

Federal, State, and local governmental 

agencies that inspect the plant, 

government assigned plant identifier, 

such as plant number and last date of 

inspection; and 

• A copy of the most recent (within 

1 year of the date of application) 

inspection report issued by a State, local 

or Federal public health regulatory 

agency and a copy of a recent laboratory 

analysis as required by the EC of the 

finished product including: Total 

aerobic bacteria, coliforms (30 °C), 

coliforms (44.5 °C), anaerobic sulphitereducing bacteria (no gas production), 

Clostridium perfringens, 

Staphylococcus aureus, Salmonella, 

Arsenic, Lead, Cadmium, Mercury, 

Chromium, Copper, Zinc, Moisture 

(105 °C), Ash (550 °C), SO2, and H2O2. 

FDA will use the information to 

maintain a list of approved firms and 

processors that will be posted on FDA’s 

Web site. FDA intends to place on the 

list only firms and processors that are 

not the subject of an unresolved 

regulatory enforcement action. If a listed 

firm or processor subsequently becomes 

the subject of a regulatory enforcement 

action or an unresolved warning letter, 

FDA will view such a circumstance as 

evidence that the firm or processor is no 

longer in compliance with applicable 

U.S. laws and regulations. Should this 

occur, FDA will take steps to remove 

that firm or processor from the list and 

send a revised list to the EC authorities, 

usually within 48 to 72 hours after the 

relevant FDA action. If a firm or 

processor has been delisted as a result 

of a regulatory enforcement action or 

unresolved warning letter, the firm or 

processor will have to reapply for 

inclusion on the list once the regulatory 

action has been resolved. 

FDA intends to update the list of 

firms and processors eligible to export 

raw, bulk collagen, and gelatin to the EC 

quarterly. Firms and processors placed 

on the approved exporters list are 

subject to audit by FDA and EC officials. 

Complete requests for inclusion must be 

submitted to FDA every 12 months to 

remain on the list. Inclusion on the list 

is voluntary. However, raw, bulk 

collagen, and gelatin products from 

firms or processors not on the approved 

exporters list for these products will not 

receive an export certificate, and these 

products may be detained at EC ports of 

entry. 

Description of Respondents: The 

respondents to this collection of 

information include U.S. producers of 

shell eggs, dairy products, game meat, 

game meat products, animal casings, 

gelatin, and collagen. 

In the Federal Register of August 18, 

2010 (75 FR 51077), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Products Number of 

respondents 

Annual 

frequency 

per response 

Total annual 

responses 

Hours per 

response Total hours 

Shell Eggs ............................................................................ 10 1 10 0.25 3 

Dairy ..................................................................................... 120 1 120 0.25 30 

Game Meat and Game Meat Products ............................... 5 1 5 0.25 1 

Animal Casings .................................................................... 5 1 5 0.25 1 

Gelatin .................................................................................. 3 1 3 0.25 1 

Collagen ............................................................................... 3 1 3 0.25 1 

Total .............................................................................. ........................ ........................ ........................ ........................ 37 

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

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71446 Federal Register / Vol. 75, No. 225 / Tuesday, November 23, 2010 / Notices 

FDA bases its estimates of the number 

of respondents and total annual 

responses on the submissions that the 

Agency has received in the past 3 years 

for each product type. To calculate the 

estimate for the hours per response 

values, we assumed that the information 

requested is readily available to the 

submitter. We expect that the submitter 

will need to gather information from 

appropriate persons in the submitter’s 

company and to prepare this 

information for submission. We believe 

that this effort should take no longer 

than 15 minutes (0.25 hour) per 

response. FDA estimates that it will 

receive 1 submission from 10 shell egg 

producers annually, for a total of 10 

annual responses. Each submission is 

estimated to take 0.25 hour per response 

for a total of 2.5 hours, rounded to 3. 

FDA estimates that it will receive 1 

submission from 120 dairy product 

producers annually, for a total of 120 

annual responses. Each submission is 

estimated to take 0.25 hour per response 

for a total of 30 hours. FDA estimates 

that it will receive one submission from 

five game meat and game meat product 

producers annually, for a total of five 

annual responses. Each submission is 

estimated to take 0.25 hour per response 

for a total of 1.25 hours, rounded to 1 

hour. FDA estimates that it will receive 

one submission from five animal casings 

producers annually, for a total of five 

annual responses. Each submission is 

estimated to take 0.25 hour per response 

for a total of 1.25 hours, rounded to 1 

hour. FDA estimates that it will receive 

one submission from three gelatin 

producers annually, for a total of three 

annual responses. Each submission is 

estimated to take 0.25 hour per response 

for a total of 0.75 hour, rounded to 1 

hour. FDA estimates that it will receive 

one submission from three collagen 

producers annually, for a total of three 

annual responses. Each submission is 

estimated to take 0.25 hour per response 

for a total of 0.75 hour, rounded to 1 

hour. Therefore, the proposed annual 

burden for this information collection is 

37 hours. 

Dated: November 18, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–29483 Filed 11–22–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0554] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Reports of 

Corrections and Removals 

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 

for reports of corrections and removal. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 24, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. 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: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, e-mail: 

Daniel.Gittleson@fda.hhs.gov. 

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. 

Reports of Corrections and Removals— 

21 CFR Part 806 (OMB Control Number 

0910–0359)—Extension 

The collection of information required 

under the reports of corrections and 

removals, part 806 (21 CFR part 806), 

implements section 519(g) of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 360i(g)), as 

amended by the Food and Drug 

Administration Modernization Act 

(FDAMA) of 1997 (21 U.S.C. 301) (Pub. 

L. 105–115). Each device manufacturer 

or importer under § 806.10 shall submit 

a written report to FDA of any action 

initiated to correct or remove a device 

to reduce a risk to health posed by the 

device, or to remedy a violation of the 

FD&C Act caused by the device that may 

present a risk to health, within 10 

working days of initiating such 

correction or removal. Each device 

manufacturer or importer of a device 

who initiates a correction or removal of 

a device that is not required to be 

reported to FDA under § 806.20 shall 

keep a record of such correction or 

removal. 

The information collected in the 

reports of corrections and removals will 

be used by FDA to identify marketed 

devices that have serious problems and 

to ensure that defective devices are 

removed from the market. This will 

assure that FDA has current and 

complete information regarding these 

corrections and removals and to 

determine whether recall action is 

adequate. 

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