Federal Register / Vol. 69, No. 26 / Monday, February 9, 2004 / Notices 5991

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://cms.hhs.gov/

regulations/pra/default.asp, or E-mail 

your request, including your address, 

phone number, OMB number, and CMS 

document identifier, to 

Paperwork@hcfa.gov, or call the Reports 

Clearance Office on (410) 786–1326. 

Written comments and 

recommendations for the proposed 

information collections must be mailed 

within 30 days of this notice directly to 

the OMB desk officer: OMB Human 

Resources and Housing Branch, 

Attention: Brenda Aguilar, New 

Executive Office Building, Room 10235, 

Washington, DC 20503.

Dated: January 29, 2004. 

Melissa Musotto, 

Acting, Paperwork Reduction Act Team 

Leader, CMS Reports Clearance Officer, Office 

of Strategic Operations and Strategic Affairs, 

Division of Regulations Development and 

Issuances.

[FR Doc. 04–2704 Filed 2–6–04; 8:45 am] 

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

[Document Identifier: CMS–R–308] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995, the 

Centers for Medicare and Medicaid 

Services (CMS) (formerly known as the 

Health Care Financing Administration 

(HCFA)), 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. 

1. Type of Information Collection 

Request: New Collection; Title of 

Information Collection: Instrument/Tool 

for Refinement of a Prospective Payment 

System for Patients in Inpatient 

Psychiatric Hospitals, and units: A pilot 

test; Form No.: CMS–10107 (OMB# 

0938–NEW); Use: This is a request to 

pilot test an instrument to refine the 

PPS for inpatient psychiatric facilities. 

This testing will include assessing the 

feasibility of administering this 

instrument, and testing the reliability, 

validity, time and process of 

administration.; Frequency: Other: Per 

stay per diem; Affected Public: Business 

or other for-profit, Not-for-profit 

institutions, and State, Local or Tribal 

Government; Number of Respondents:

1,120; Total Annual Responses: 1,120; 

Total Annual Hours: 2,464. 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: The State 

Children’s Health Insurance Program 

and Supporting Regulations in 42 CFR 

431.636, 457.50, 457.60, 457.70, 

457.340, 457.350, 457.431, 457.440, 

457.525, 457.560, 457.570, 457.740, 

457.750, 457.810, 457.940, 457.945, 

457.965, 457.985, 457.1005, 457.1015, 

and 457.1180; Form No.: CMS–R–308 

(OMB# 0938–0841); Use: States are 

required to submit title XXI plans and 

amendments for approval by the 

Secretary pursuant to section 2102 of 

the Social Security Act in order to 

receive funds for initiating and 

expanding health insurance coverage for 

uninsured children. States are also 

required to submit State expenditure 

and statistical reports, annual reports 

and State evaluations to the Secretary as 

outlined in title XXI of the Social 

Security Act and furnish assorted 

notices to recipients; Frequency:

Annually; Affected Public: State, Local, 

or Tribal Government; Number of 

Respondents: 88; Total Annual 

Responses: 12,187,482; Total Annual 

Hours: 838,714. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’s Web 

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

regulations/pra/default.asp, or E-mail 

your request, including your address, 

phone number, OMB number, and CMS 

document identifier, to 

Paperwork@hcfa.gov, or call the Reports 

Clearance Office on (410) 786–1326. 

Written comments and 

recommendations for the proposed 

information collections must be mailed 

within 60 days of this notice directly to 

the CMS Paperwork Clearance Officer 

designated at the following address: 

CMS, Office of Strategic Operations and 

Regulatory Affairs, Division of 

Regulations Development and 

Issuances, Attention: Melissa Musotto, 

Room C5–14–03, 7500 Security 

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: January 29, 2004. 

Melissa Musotto, 

Acting, Paperwork Reduction Act Team 

Leader, Office of Strategic Operations and 

Strategic Affairs, Division of Regulations 

Development and Issuances.

[FR Doc. 04–2705 Filed 2–6–04; 8:45 am] 

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N–0482]

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Mammography 

Facilities, Standards, and Lay 

Summaries for Patients

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 March 10, 

2004.

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 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:

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223.

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. 

5992 Federal Register / Vol. 69, No. 26 / Monday, February 9, 2004 / Notices 

Mammography Facilities, Standards, 

and Lay Summaries for Patients—21 

CFR Part 900 (OMB Control Number 

0910–0309)—Extension

Public Law 102–539, the 

Mammography Quality Standards Act of 

1992 (MQSA) (42 U.S.C. 263b) as 

amended by the Mammography Quality 

Standards Reauthorization Act 

(MQSRA) of 1998 (Public Law 105–248) 

establishes the authority for a Federal 

certification and inspection program for 

mammography facilities; regulations 

and standards for accreditation bodies 

for mammography facilities; and 

standards for mammography equipment, 

personnel, and practices, including 

quality assurance. MQSRA extended the 

life of the MQSA program for 4 years 

from its original expiration date of 1998 

until 2002, and also modified some of 

the provisions. The most significant 

modification from a report and 

recordkeeping viewpoint under 

§ 900.12(c)(2) was that mammography 

facilities were required to send a lay 

summary of each examination to the 

patient.

FDA, under this regulation, collects 

information from accreditation bodies 

and mammography facilities by 

requiring each accreditation body to 

submit an application for approval and 

to establish a quality assurance program. 

On the basis of accreditation, facilities 

are certified by FDA and must 

prominently display their certificate. 

FDA uses the information to ensure that 

private, nonprofit organizations or state 

agencies meet the standards established 

by FDA for accreditation bodies to 

accredit facilities that provide 

mammography services.

Information collected from 

mammography facilities has also been 

used to ensure that the personnel, 

equipment, and quality systems has and 

continues to meet the regulations under 

MQSA and will be used by patients to 

manage their health care properly. The 

intent of these regulations is to assure 

safe, reliable, and accurate 

mammography on a nationwide level. 

The most likely respondents to this 

information collection will be 

accreditation bodies and mammography 

facilities seeking certification.

FDA estimates the burden of this 

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section Number of Respondents 

Annual Frequency per 

Response 

Total Annual 

Responses 

Hours per Response Total Hours Total Capital 

Costs 

Total Operating & 

Maintenance 

Costs 

900.3 1 0.33 0.33 60 20

900.3(b)(3) 1 0.33 0.33 60 20 $50

900.3(c) 5 0.33 1.67 15 25

900.3(e) 1 0.1 0.1 1 0.1

900.3(f)(2) 1 0.1 0.1 200 20

900.4(c)&(2) 9,200 0.33 3,067 1 3,067

900.4(e) 9,450 1 9,450 8 75,600

900.4(f) 276 1 276 7 1,932

900.4(h) 5 1 6130 1 6,130

900.4(i)(2) 1 0.33 0.33 1 0.33

900.6(c)(1) 1 0.1 0.1 1 0.1

900.11(b)(1) 9,200 0.33 3,067 2 6,134

900.11(b)(2) 250 1 250 2 500

900.11(b)(3) 5 1 5 .5 2.5

900.11(c) 9,200 0.04 368 5 1,840 $1,000

900.12(c)(2) 9,200 3,478 36,000,000 5 minutes 3,000,000

900.12(j)(1) 25 1 25 1 25

900.12(j)(2) 25 0.08 2 50 100

900.15(c) 9,200 0.05 46 2 92

900.15(d)(3)(ii) 9,200 0.0001 0.92 2 1.8 $10

900.18(c) 9,300 0.00032 3 2 6 $30

900.18(e) 10 0.0100 0.1 1 0.10 $10

FDA Form 3422 800 1 800 .25 200

Total 3,095,716 $50 $1,040

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section Number of Recordkeepers 

Annual Frequency 

of Recordkeeping 

Total Annual 

Records 

Hours per Recordkeeper Total Hours 

Total Operating & 

Maintenance 

Costs 

900.3(f)(1) 5 0.02 0.1 200 20

900.4(g) 1 0.33 0.33 1 0.33

900.12(c)(4) 9,200 1 9,200 1 9,200 $18,400

900.12(e)(13) 9,200 52 478,400 0.125 59,800

900.12(f) 9,200 1 9,200 5 46,000

900.12(h) 9,200 2 18,400 0.5 9,200

Total 124,220 $18,400

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

The most likely respondents to this 

information collection will be 

accreditation bodies and mammography 

facilities seeking certification. The total 

capital cost associated with these 

regulations is $50 (§ 900.3(b)(3)). This is 

a one-time start up cost associated with 

the application for approval as an 

accreditation body. The total operating 

and maintenance cost associated with 

these requirements is $19,440. This is 

the cost that facilities bear to maintain 

Federal Register / Vol. 69, No. 26 / Monday, February 9, 2004 / Notices 5993

records under the initial and final 

mammography regulations.

Dated: January 29, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–2641 Filed 2–6–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Proposed Information Collection: 

Request for Public Comment: 60-Day 

Notice

AGENCY: Indian Health Service, HHS.

ACTION: Request for Public Comment: 

60-day Proposed Collection; Hoz’ho’nii: 

An Intervention to Increase Breast and 

Cervical Cancer Screening Among 

Navajo Women. 

SUMMARY: In compliance with Section 

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

Reduction Act of 1995, to provide a 60-

day advance opportunity for public 

comment on proposed information 

collection projects, the Indian Health 

Service (IHS) is publishing for comment 

a summary of a proposed information 

collection to be submitted to the Office 

of Management and Budget (OMB) for 

review. 

Proposed Collection 

Title: Hoz’ho’nii: An Intervention to 

Increase Breast and Cervical Cancer 

Screening Among Navajo Women. 

Type of Information Collection 

Request: Previously Approved 

Collection. 

Form Number: None. 

Need and Use of the Information 

Collection: The information is needed to 

evaluate a culturally appropriate 

educational outreach program designed 

to increase breast and cervical cancer 

screening among Navajo women ages 20 

and older. The purpose is to identify 

barriers that may prevent Navajo women 

from participating in breast and cervical 

cancer screening by comparing changes 

in knowledge, attitudes, and behaviors 

of three study groups; educational 

outreach only, education outreach plus 

chapter-based clinic, and a control 

group. Results will be used to assess the 

impact of the impact of the educational 

outreach program, improve breast and 

cervical cancer screening, and to guide 

the IHS and Tribal health programs in 

the delivery of culturally appropriate 

intervention to reduce mortality rates 

from breast and cervical cancer among 

Navajo women. 

Affected Public: Individuals. 

Type of Respondents: Individuals. 

The table below provides the 

estimated burden response for this 

information collection:

ESTIMATED BURDEN RESPONSE TABLE

Data collection instrument Estimated number 

of respondents 

Responses 

per respondent Average burden hour per response * Total annual 

burden hrs. 

KAB Pretest ................................................. 450 1 0.42 hr (25 minutes) ................................... 188.0 hrs 

KAB Post test .............................................. 450 1 0.42 hr (25 minutes) ................................... 188.0 hrs 

Interviews ..................................................... 30 1 0.25 hr (15 minutes) ................................... 8.0 hrs 

TOTAL .................................................. 930 1 ..................................................................... 384.0 hrs 

* 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 for this information collection 

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 fashion; 

(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. 

Send Comments and Requests For 

Further Information: Send your written 

comments, requests for more 

information on the proposed collection, 

or requests to obtain a copy of the data 

collection instrument(s) and 

instructions to: Ms. Christina Ingersoll, 

IHS Reports Clearance Officer, 12300 

Twinbrook Parkway, Suite 450, 

Rockville, MD 20852–1601, call non-toll 

free (301) 443–5938, send via facsimile 

to (301) 443–1522, or send your E-mail 

requests, comments, and return address 

to: cingerso@hqe.ihs.gov.

Comment Due Date: Your comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60-days of the date of 

this publication.

Dated: January 26, 2004. 

Charles W. Grim, 

Assistant Surgeon General, Director, Indian 

Health Service.

[FR Doc. 04–2642 Filed 2–6–04; 8:45 am] 

BILLING CODE 4160–16–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Notice of Intent To Prepare an 

Environmental Impact Statement for 

the National Emerging Infectious 

Disease Laboratories Facility in 

Boston, MA

AGENCY: National Institutes of Health 

(NIH), DHHS.

ACTION: Notice of intent to prepare an 

environmental impact statement for the 

National Emerging Infectious Diseases 

Laboratories facility in Boston, MA—

extension of comment period and 

rescheduling of public meeting. 

SUMMARY: The Department of Health and 

Human Services (DHHS), National 

Institutes of Health (NIH), announced its 

intent to prepare an environmental 

impact statement (EIS) to evaluate a 

proposed new National Emerging 

Infectious Disease Laboratories facility 

in Boston, MA in the Federal Register

on January 9, 2004. The Public Scoping 

meeting has been rescheduled to