Federal Register / Vol. 70, No. 170 / Friday, September 2, 2005 / Notices 52397 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel: Understanding Social 

Disparities in Chronic Disease Health 

Outcomes, Program Announcement 

Number DP–05–132; Correction 

Correction: Notice of program 

announcement number DP–05–132 was 

published in the Federal Register on 

August 12, 2005, Volume 70, Number 

155, pages 47214–47215. The meeting 

has been cancelled. 

Time and Date: 3 p.m.–5 p.m., 

September 1, 2005 (Closed). 

Meeting Location: Teleconference. 

For Further Information Contact: 

Gwen Cattledge, PhD, Scientific Review 

Administrator, National Center for 

Chronic Disease Prevention and Health 

Promotion, 4770 Buford Highway, MS–

K92, Atlanta, GA 30341, Telephone 

(770) 488–4655. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both CDC 

and the Agency for Toxic Substances 

and Disease Registry. 

Diane Allen, 

Director, Acting Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. 05–17592 Filed 8–31–05; 11:41 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10041] 

Emergency Clearance: Public 

Information Collection Requirements 

Submitted to the Office of Management 

and Budget (OMB) 

AGENCY: Centers for Medicare & 

Medicaid Services. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

We are, however, requesting an 

emergency review of the information 

collection referenced below. In 

compliance with the requirement of 

section 3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, we have 

submitted to the Office of Management 

and Budget (OMB) the following 

requirements for emergency review. We 

are requesting an emergency review 

because the collection of this 

information is needed before the 

expiration of the normal time limits 

under OMB’s regulations at 5 CFR part 

1320. This is necessary to ensure 

compliance with an initiative of the 

Administration. 

The mandate for the collection of 

information for the Long-Term Care 

Awareness Project originates with a 

presidential initiative in the FY 2000 

budget for CMS. The overall goal of this 

initiative is to help Americans and their 

families with long-term health needs 

through a ‘‘national campaign to 

educate Medicare beneficiaries about 

coverage available under the new 

program and how to evaluate long-term 

care options.’’ Current and future 

beneficiaries now have the opportunity 

to receive information from a wide 

variety of printed material, telephone 

information, and other electronic 

resources. This collection of information 

is necessary to design and test evidencebased communication strategies for a 

national campaign to address the longterm health care planning needs of all 

Americans. 

CMS is requesting OMB review and 

approval of this collection by October 3, 

2005, with a 180-day approval period. 

Written comments and 

recommendations will be accepted from 

the public if received by the individuals 

designated below by October 1, 2005. 

Type of Information Collection 

Request: Reinstatement, with change, of 

a previously approved collection for 

which approval has expired; Title of 

Information Collection: Long-Term Care 

Awareness Campaign Demonstration 

Project; Use: Data will be collected to 

pilot test a national campaign to educate 

current and future Medicare 

beneficiaries and their families about 

long-term care needs. Project findings 

will be used to design and implement a 

nationwide campaign. Respondents will 

be from ages 50–70; Form Number: 

CMS–10041 (OMB#: 0938–0847); 

Frequency: One-time; Affected Public: 

Individuals or Households; Number of 

Respondents: 4,500; Total Annual 

Responses: 4,500; Total Annual Hours: 

1,350. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web site 

address at http://www.cms.hhs.gov/ 

regulations/pra or E-mail your request, 

including your address, phone number, 

OMB number, and CMS document 

identifier, to Paperwork@cms.hhs.gov, 

or call the Reports Clearance Office on 

(410) 786–1326. 

Interested persons are invited to send 

comments regarding the burden or any 

other aspect of these collections of 

information requirements. However, as 

noted above, comments on these 

information collection and 

recordkeeping requirements must be 

received by the designees referenced 

below by October 1, 2005: 

Centers for Medicare & Medicaid 

Services, Office of Strategic 

Operations and Regulatory Affairs, 

Room C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–

1850, Attn: Melissa Musotto, CMS–

10041, and, 

OMB Human Resources and Housing 

Branch, Attention: Christopher 

Martin, New Executive Office 

Building, Room 10235, Washington, 

DC 20503. 

Dated: August 25, 2005. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 05–17524 Filed 9–1–05; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0335] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Device 

Recall Authority 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

52398 Federal Register / Vol. 70, No. 170 / Friday, September 2, 2005 / Notices 

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 

medical device recall authority. 

DATES: Submit written or electronic 

comments on the collection of 

information by November 1, 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: 

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223. 

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. 

Medical Device Recall Authority—21 

CFR Part 810 (OMB Number 0910– 

0432)—Extension 

This collection implements medical 

device recall authority provisions under 

section 518(e) of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

360h) and part 810 (21 CFR part 810). 

Section 518(e) of the act gives FDA the 

authority to issue an order requiring the 

appropriate person, including 

manufacturers, importers, distributors, 

and retailers of a device, to immediately 

cease distribution of such device, to 

immediately notify health professionals 

and device-user facilities of the order, 

and to instruct such professionals and 

facilities to cease use of such device, if 

FDA finds that there is reasonable 

probability that the device intended for 

human use would cause serious adverse 

health consequences or death. 

Section 518(e) of the act sets out a 

three-step procedure for issuance of a 

mandatory device recall order. First, if 

there is a reasonable probability that a 

device intended for human use would 

cause serious, adverse health 

consequences or death, FDA may issue 

a cease distribution and notification 

order requiring the appropriate person 

to immediately do the following: (1) 

Cease distribution of the device, (2) 

notify health professionals and device 

user facilities of the order, and (3) 

instruct those professionals and 

facilities to cease use of the device. 

Second, FDA will provide the person 

named in the cease distribution and 

notification order with the opportunity 

for an informal hearing on whether the 

order should be modified, vacated, or 

amended to require a mandatory recall 

of the device. Third, after providing the 

opportunity for an informal hearing, 

FDA may issue a mandatory recall order 

if the agency determines that such an 

order is necessary. 

The information collected under the 

recall authority will be used by FDA to 

ensure that all devices entering the 

market are safe and effective, to 

accurately and immediately detect 

serious problems with medical devices, 

and to remove dangerous and defective 

devices from the market. 

The respondents to this proposed 

collection of information are 

manufacturers, importers, distributors, 

and retailers of medical devices. 

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 

810.10(d) 2 1 2 8 16 

810.11(a) 1 1 1 8 8 

810.12(a) and (b) 1 1 1 8 8 

810.14 2 1 2 16 32 

810.15(a) through (d) 2 1 2 16 32 

810.15(e) 10 1 10 1 10 

810.16 2 12 24 40 960 

810.17 2 1 2 8 16 

Federal Register / Vol. 70, No. 170 / Friday, September 2, 2005 / Notices 52399 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Total 1,082 

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

The following burden estimates are 

based on FDA’s experience with 

voluntary recalls under 21 CFR part 7. 

FDA expects no more than two 

mandatory recalls per year, as most 

recalls are done voluntarily. 

Section 810.10(d)—FDA estimates 

that it will take approximately 8 hours 

for the person named in a cease 

distribution and notification order to 

gather and submit the information 

required by this section. The total 

estimated annual burden is 16 hours. 

Section 810.11(a)—Based on 

experience in similar situations, FDA 

expects that there will be only one 

request for a regulatory hearing per year 

and that it will take approximately 8 

hours to prepare this request. 

Section 810.12(a) and (b)—Based on 

experience in similar situations, FDA 

expects that there will be only one 

written request for a review of a cease 

distribution and notification order per 

year and that it will take approximately 

8 hours to prepare this request. 

Section 810.14—Based upon its 

experience with voluntary recalls, FDA 

estimates that it will take approximately 

16 hours to develop a strategy for 

complying with the order. 

Section 810.15(a) through (d)—Based 

upon its experience with voluntary 

recalls, FDA estimates that it will take 

approximately 16 hours to notify each 

health professional, user facility, or 

individual of the order. 

Section 810.15(e)—Based upon its 

experience with voluntary recalls, FDA 

estimates that there will be 

approximately 5 consignees per recall 

(10 per year) who will be required to 

notify their consignees of the order. 

FDA estimates that it will take them 

about 1 hour to do so. 

Section 810.16—FDA estimates that it 

would take no more than 40 hours to 

assemble and prepare a written status 

report required by a recall. The status 

reports are prepared by manufacturers 6 

to 12 times each year. Therefore, each 

manufacturer would spend no more 

than 480 hours each year preparing 

status reports. If there were two FDA 

invoked recalls each year, the total 

burden hours estimated would be 960 

hours each year. 

Section 810.17—Based on experience 

with similar procedures, FDA estimates 

that it would take 8 hours to draft a 

written request for termination of a 

cease distribution and notification or 

mandatory recall order. 

Dated: August 26, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–17499 Filed 9–1–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Blood Products Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: Blood Products 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on September 29, 2005, from 8 a.m. 

to 5 p.m. 

Location: Food and Drug 

Administration, conference room 1066, 

5630 Fishers Lane, Rockville, MD. 

Contact Person: Donald W. Jehn or 

Pearline K. Muckelvene, Center for 

Biologics Evaluation and Research 

(HFM–71), Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852, 301–827–0314, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014519516. Please call the Information 

Line for up-to-date information on this 

meeting. 

Agenda: On September 29, 2005, the 

committee will discuss new drug 

application (NDA) 21–882 proposed 

trade name EXJADE (deferasirox) 

Tablets for Oral Suspension, Novartis 

Pharmaceutical Corp., proposed for the 

indication of the treatment of chronic 

iron overload due to blood transfusions 

(transfusional hemosiderosis). 

Following this discussion, the 

committee will hear an overview of the 

research programs in the Laboratory of 

Hemostasis and the Laboratory of 

Plasma Derivatives, Division of 

Hematology, Office of Blood Research 

and Review, Center for Biologics 

Evaluation and Research (CBER), and in 

closed session will discuss the report 

from the laboratory site visit of February 

25, 2005. 

Procedure: On September 29, 2005, 

from 8 a.m. to 4:15 p.m., the meeting is 

open to the public. Interested persons 

may present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person by September 22, 2005. Oral 

presentations from the public will be 

scheduled between approximately 11:15 

a.m. and 12:15 p.m. Time allotted for 

each presentation may be limited. Those 

desiring to make formal oral 

presentations should notify the contact 

person before September 22, 2005, and 

submit a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation. 

Closed Committee Deliberations: On 

September 29, 2005, from 

approximately 4:15 p.m. to 5 p.m., the 

meeting will be closed to permit 

discussion where disclosure would 

constitute a clearly unwarranted 

invasion of personal privacy (5 U.S.C. 

552b(c)(6)). The committee will discuss 

a review of internal research programs 

in the Division of Hematology, Office of 

Blood Research and Review, Center for 

Biologics Evaluation and Research. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Donald Jehn 

or Pearline K. Muckelvene at least 7 

days in advance of the meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2).