Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 / Notices 59075 

guidance needs to be revised at a later 

date. 

ADDRESSES: Submit written requests for 

single copies on a 3.5′′ diskette of the 

guidance document entitled 

‘‘Compliance With Section 301 of the 

Medical Device User Fee and 

Modernization Act of 2002, as 

amended—Prominent and Conspicuous 

Mark of Manufacturers on Single-Use 

Devices’’ to the Division of Small 

Manufacturers, International, and 

Consumer Assistance (HFZ–220), Center 

for Devices and Radiological Health, 

Food and Drug Administration, 1350 

Piccard Dr., Rockville, MD 20850. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request, or fax your request to 301–443–

8818. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit written comments concerning 

this draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Casper E. Uldriks, Center for Devices 

and Radiological Health (HFZ–300), 

Food and Drug Administration, 2098 

Gaither Rd., Rockville, MD 20850, 240–

276–0106. 

SUPPLEMENTARY INFORMATION: 

I. Background 

MDUFMA (Public Law 107–250) 

amended section 502 of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 352) to require a device, or 

an attachment to the device, to bear 

prominently and conspicuously the 

name of the manufacturer, a generally 

recognized abbreviation of such name, 

or a unique and generally recognized 

symbol identifying the manufacturer. 

This labeling provision applied to all 

devices and all device manufacturers, 

including reprocessors. 

On August 1, 2005, MDUFSA (Public 

Law 109–43) amended section 502(u) of 

the act by limiting the provision to 

reprocessed single-use devices (SUDs) 

and the manufacturers who reprocess 

them. Therefore, section 502(u) of the 

act, as amended by MDUFSA, no longer 

sets forth requirements for original 

equipment manufacturers, unless they 

also reprocess SUDs. Under the 

amended provision, if an original device 

or an attachment to it does not 

prominently and conspicuously bear the 

name of the manufacturer of the original 

device, a generally recognized 

abbreviation of such name, or a unique 

and generally recognized symbol 

identifying such manufacturer, the 

manufacturer who reprocesses the SUD 

may identify itself using a detachable 

label on the packaging of the device. 

Section 2(c)(2) of MDUFSA requires 

that FDA issue guidance not later than 

180 days after the date of its enactment 

to identify the circumstances under 

which the identifying mark of a 

manufacturer of an original device is not 

‘‘prominent and conspicuous,’’ as used 

in section 502(u) of the act. When 

finalized, this guidance document will 

satisfy this MDUFSA requirement. As 

stated previously, FDA requests that 

interested person submit their 

comments on the draft guidance within 

30 days of its publication. FDA will 

consider these comments to determine 

whether to revise the guidance before 

issuing it in final form. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized will 

represent the agency’s current thinking 

on ‘‘Compliance With Section 301 of the 

Medical Device User Fee and 

Modernization Act of 2002, as 

amended—Prominent and Conspicuous 

Mark of Manufacturers on Single-Use 

Devices.’’ It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

To receive ‘‘ Compliance With Section 

301 of the Medical Device User Fee and 

Modernization Act of 2002, as 

amended—Prominent and Conspicuous 

Mark of Manufacturers on Single-Use 

Devices’’ by fax machine, call the CDRH 

Facts-On-Demand system at 800–899–

0381 or 301–827–0111 from a touchtone telephone. Press 1 to enter the 

system. At the second voice prompt, 

press 1 to order a document. Enter the 

document number (1217) followed by 

the pound sign (#). Follow the 

remaining voice prompts to complete 

your request. 

Persons interested in obtaining a copy 

of the draft guidance may also do so by 

using the Internet. The Center for 

Devices and Radiological Health (CDRH) 

maintains an entry on the Internet for 

easy access to information including 

text, graphics, and files that may be 

downloaded to a personal computer 

with Internet access. Updated on a 

regular basis, the CDRH home page 

includes device safety alerts, Federal 

Register reprints, information on 

premarket submissions (including lists 

of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http://www.fda.gov/ 

ohrms/dockets. 

IV. Paperwork Reduction Act of 1995 

This draft guidance contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). In the Federal 

Register of September 29, 2005 (70 FR 

56910), FDA published a 60-day notice 

soliciting comments on the information 

collection provisions contained in this 

guidance. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), written or electronic 

comments regarding this draft guidance. 

Submit electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: October 3, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–20329 Filed 10–7–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Proposed Information Collection: Final 

Rule To Implement Title V of the Tribal 

Self-Governance Amendments of 2000; 

Request for Public Comment: 30-Day 

Notice 

AGENCY: Indian Health Service, HHS. 

59076 Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 / Notices 

ACTION: Request for Public Comment: 

30-day Proposed Information Collection: 

Final Rule to Implement Title V of the 

Tribal Self-Governance Amendments of 

2000. 

SUMMARY: The Indian Health Service 

(IHS), as part of its continuing effort to 

reduce paperwork and respondent 

burden, conducts a pre-clearance 

consultation program to provide the 

general public and Federal agencies 

with an opportunity to comment on 

proposed and/or continuing collections 

of information in accordance with the 

Paperwork Reduction Act of 1995 

(PRA95) (44 U.S.C. 3506(c)(2)(A)). This 

program helps to ensure that requested 

data can be provided in the desired 

format, reporting burden (time and 

financial resources) is minimized, 

collection instruments are clearly 

understood, and the impact of collection 

requirements on respondents can be 

properly assessed. As required by 

section 3507(a)(1)(D) of the Act, the 

proposed information collection has 

been submitted to the Office of 

Management and Budget (OMB) for 

review and approval. The IHS received 

no comments in response to the 60-day 

Federal Register notice (70 FR 44663) 

published on August 3, 2005. The 

purpose of this notice is to allow an 

additional 30 days for public comment 

to be submitted directly to OMB. 

Proposed Collection: Title: 0917–

0026, ‘‘Final Rule to Implement Title V 

of the Tribal Self-Governance 

Amendments of 2000’’. Type of 

Information Collection Request: 

Extension, without revision, of currently 

approved information collection, 0917–

0026, ‘‘Final Rule to Implement Title V 

of the Tribal Self-Governance 

Amendments of 2000’’. Form Number: 

None. Forms: None. Need and Use of 

Information Collection: The ‘‘Tribal 

Self-Governance Amendments of 2000’’, 

Public Law 106–206 (the act), repeals 

Title III of the Indian Self-Determination 

Act, Public Law 93–638, as amended, 

(ISDA) and enacts Title V that 

established a permanent SelfGovernance program within DHHS. 

Thus Indian and Alaska Native Tribes 

are now able to compact for the 

operation, control, and redesign of 

various IHS activities on a permanent 

basis. The final rule has been negotiated 

among representatives of SelfGovernance and non-Self-Governance 

Tribes and the DHHS. The final rule 

included provision governing how 

DHHS/IHS carries out its responsibility 

to Indian Tribes under the Act and how 

Indian Tribes carry out their 

responsibilities under the Act. As 

required by section 517(b) of the Act, 

the Department has developed this final 

rule with active Tribal participation of 

Indian Tribes, inter-Tribal consortia, 

Tribal organizations and individual 

Tribal members, using the guidance of 

the Negotiated Rulemaking Act, 5 U.S.C. 

561 et seq. Health status reporting 

requirements will be negotiated on an 

individual Tribal basis and included in 

individual compacts of funding 

agreements. Response to the data 

collection continues to be voluntary; 

however, submission of the data is 

essential to participation in the Tribal 

Self-Governance process. SelfGovernance Tribes have the option of 

participating in the Tribal SelfGovernance process. Self-Governance 

Tribes have the option of participating 

in a voluntary national uniform data 

collection effort with the IHS. The 

department is seeking continued OMB 

approval of the collection of information 

identified in the following sections of 

the regulations: Subpart C-Selection of 

Tribes for Participation in SelfGovernance, Subpart D and E-Compact 

and Funding Agreement, Subpart NConstruction Projects, and Subpart PAppeals. Affected Public: Individual 

Tribes. Type of Respondents: Tribal 

Representatives. 

The table below provides the 

estimated burden hours for this 

information collection: 

TABLE.—ESTIMATED ANNUAL BURDEN HOURS

CFR section 

Estimated 

number of 

respondents 

Responses 

per 

respondent 

Average burden 

hour per 

response 

Total annual 

burden hours 

Subpart C—Eligibility criteria ......................................................................... 50 1 10 .0 500 

Subpart D—Self-governance compact and Subpart E—Funding agreement 50 1 34 .0 1,700 

Subpart N—Construction ............................................................................... 30 1 40 1,200 

Subpart P—Appeals ...................................................................................... 8 1 40 320 

Total Annual Burden ............................................................................... ........................ ........................ .......................... 3,720 

There are no Capital Costs, Operating 

Costs and/or Maintenance Costs to 

report. 

Request for Comments: Your written 

comments and/or suggestions are 

invited on one or more of the following 

points: (a) Whether the information 

collection activity is necessary to carry 

out an agency function; (b) whether the 

agency processes the information 

collected in a useful and timely 

function; (c) the accuracy of public 

burden estimate (the estimated amount 

of time needed for individual 

respondents to provide the requested 

information); (d) whether the 

methodology and assumptions used to 

determine the estimate are logical; (e) 

ways to enhance the quality, utility, and 

clarity of the information being 

collected; and (f) ways to minimize the 

public burden through the use of 

automated, electronic, mechanical, or 

other technological collection 

techniques or other forms of information 

technology. 

Direct Comments to OMB: Send your 

written comments and suggestions 

regarding the proposed information 

collection contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, directly to: Office of Management 

and Budget, Office of Regulatory Affairs, 

New Executive Office Building, Room 

10235, Washington, DC 20503, 

Attention: Allison Eydt, Desk Officer for 

IHS. 

Send requests for more information 

on the proposed collection or to obtain 

a copy of the data collection 

instrument(s) and instructions to: Mrs. 

Christina Rouleau, IHS Reports 

Clearance Officer, 801 Thompson 

Avenue, TMP Suite 450, Rockville, MD 

20852–1601, call non-toll free (301) 

443–5938, send via facsimile to (301) 

443–2316, or send your e-mail requests, 

comments, and return address to: 

crouleau@hqe.ihs.gov. 

For Further Information directly 

pertaining to the proposed data 

collection instrument and/or the 

process, please contact Tena Larney, 

Reyes Building, 801 Thompson Avenue, 

Suite 200, Rockville, MD 20852–1627, 

Telephone (301) 443–7821. 

Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 / Notices 59077 

Comment Due Date: You comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: October 4, 2005. 

Robert G. McSwain, 

Deputy Director, Indian Health Service. 

[FR Doc. 05–20330 Filed 10–7–05; 8:45 am] 

BILLING CODE 4165–16–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Proposed Collection: Indian Health 

Service Loan Repayment Program; 

Request for Public Comment: 30-Day 

Notice 

AGENCY: Indian Health Service, HHS. 

ACTION: Request for Public Comment: 

30-day Proposed Information Collection: 

Indian Health Service Loan Repayment 

Program. 

SUMMARY: In compliance with Section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, for opportunity 

for public comment on proposed 

information collection projects, the 

Indian Health Service (IHS) has 

submitted to the Office of Management 

and Budget (OMB) a request to review 

and approve the information collection 

list below. This proposed information 

collection project was published in the 

August 3, 2005, Federal Register (70 FR 

44662) and allowed 60 days for public 

comment. No public comment was 

received in response to the notice. The 

purpose of this notice is to allow 30 

days for public comment to be 

submitted to OMB. 

Proposed Collection: Title: 0917–

0014, ‘‘Indian Health Service Loan 

Repayment Program’’. Type of 

Information Collection Request: 

Extention of a currently approved 

collection which expires December 31, 

2005. Form Number: No reporting forms 

required. Need and Use of Information 

Collection: The IHS Loan Payment 

Program (LRP) identifies health 

professionals with pre-existing financial 

obligations for education expenses that 

meet program criteria and who are 

qualified and willing to serve at, often 

remote, IHS health care facilities. Under 

the program, eligible health 

professionals sign a contract under 

which the IHS agrees to repay part or all 

of their indebtedness for professional 

training education. In exchange, the 

health professionals agree to serve for a 

specified period of time in IHS health 

care facilities. Eligible health 

professionals that wish to apply must 

submit an application to participate in 

the program. The application requests 

personal, demographic and educational 

training information, including 

information on the educational loans of 

the individual for which repayment is 

being requested (i.e., date, amount, 

account number, purpose of each loan, 

interest rate, the current balance, etc). 

The data collected is needed and used 

to evaluate applicant eligibility; rank 

and prioritize applicants by specialty; 

assign applicants to IHS health care 

facilities; determine payment amounts 

and schedules for paying the lending 

institutions; and to provide data and 

statistics for program management 

review and analysis. Affected Public: 

Individual and households. Type of 

Respondents: Individuals. Table 1 

below provides the following: Types of 

data collection instruments, estimated 

number of respondents, number of 

responses per respondent, annual 

number of responses, average burden 

hour per response, and total annual 

burden hour. 

TABLE 1.—ESTIMATED BURDEN HOURS

Data collection instrument 

Estimated 

number of 

respondents 

Responses 

per respondent 

Average burden 

hour per 

response* 

Total annual 

burden hours 

Section I ...................................................................................................... 425 1 0.25 (15 min) .... 106 .25 

Section II ..................................................................................................... 425 1 0.25 (30 min) .... 212 .5 

Section III .................................................................................................... 425 4 0.25 (15 min) .... 425 

Contract ...................................................................................................... 425 1 0.334 (20 min) .. 141 .95 

Affidavit ....................................................................................................... 425 1 0.167 (10 min) .. 70 .97 

Lender’s Certification .................................................................................. 1,700 1 .025 (15 min ..... 425 

*For ease of understanding, burden hours are also provided in actual minutes. 

There are no Capital Costs, Operating 

Costs and/or Maintenance Costs to 

report. 

Request for Comments: Your written 

comments and/or suggestions are 

invited on one or more of the following 

points: (a) Whether the information 

collection activity is necessary to carry 

out an agency function; (b) whether the 

IHS processes the information collected 

in a useful and timely fashion; (c) the 

accuracy of the public burden estimate 

(the estimated amount of time needed 

for individual respondents to provide 

the requested information); (d) whether 

the methodology and assumptions used 

to determine the estimate are logical; (e) 

ways to enhance the quality, utility, and 

clarity of the information being 

collected; and (f) ways to minimize the 

public burden through the use of 

automated, electronic, mechanical, or 

other technological collection 

techniques or other forms of information 

technology. 

Direct Comments to OMB: Send your 

written comments and suggestions 

regarding the proposed information 

collection contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, to: Office of Management and 

Budget, Office of Regulatory Affairs, 

New Executive Office Building, Room 

10235, Washington, DC 20503, 

Attention: Desk Officer for IHS. 

To request more information on the 

proposed collection or to obtain a copy 

of the data collection instrument(s) and/ 

or instruction(s), contact: Mrs. Christina 

Rouleau, IHS Reports Clearance Officer, 

801 Thompson Avenue, TMP Suite 450, 

Rockville, MD 20852–1601, or call nontoll free (301) 443–5938 or send via 

facsimile to (301) 443–2316, or send 

your E-mail requests, comments, and 

return address to: crouleau@hqe.ihs.gov. 

Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received on or before November 10, 

2005. 

Dated: September 4, 2005. 

Robert G. McSwain, 

Deputy Director, Indian Health Service. 

[FR Doc. 05–20331 Filed 10–7–05; 8:45 am] 

BILLING CODE 4165–16–M