Federal Register / Vol. 62, No. 236 / Tuesday, December 9, 1997 / Notices 64851

Fee category Fee rates for FY

1997

Supplements requiring clinical data .... $128,423

Establishments ............ $141,966

Products ...................... $18,591

VI. Implementation of Adjusted Fee

Schedule

A. Application Fees

Any application or supplement

subject to fees under the PDUFA that is

submitted after December 31, 1997,

must be accompanied by the

appropriate application fee established

in the new fee schedule. FDA will bill

applicants who submitted application

fees between October 1, 1997, and

December 31, 1997, based on the

adjusted rate schedule.

B. Establishment and Product Fees

By December 31, 1997, FDA will issue

invoices for establishments and product

fees for FY 1998 under the new fee

schedules. Payment will be due by

January 31, 1998. FDA will issue

invoices in October 1998 for any

products and establishments subject to

fees for FY 1998 that qualify for fees

after the December 1997 billing.

Dated: December 3, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32164 Filed 12–8–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0151]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Applications for Exemption from

Preemptions of Medical Device

Requirements’’ has been approved by

the Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of May 16, 1997 (62 FR

27059), the agency announced that the

proposed information collection had

been submitted to OMB for review and

clearance under section 3507 of the PRA

(44 U.S.C. 3507). An agency may not

conduct or sponsor, and a person is not

required to respond to, a collection of

information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0129. The

approval expires on July 31, 2000.

Dated: December 2, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32166 Filed 12–8–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0266]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Administrative Detention and Banned

Medical Devices’’ has been approved by

the Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of July 16, 1997 (62 FR

38095), the agency announced that the

proposed information 3collection had

been submitted to OMB for review and

clearance under section 3507 of the PRA

(44 U.S.C. 3507). An agency may not

conduct or sponsor, and a person is not

required to respond to, a collection of

information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0114. The

approval expires on September 30,

2000.

Dated: November 30, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32167 Filed 12–8–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–484]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

In compliance with the requirement

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

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the 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.

Type of Information Collection

Request: Extension of a currently

approved collection without change;

Title of Information Collection:

Attending Physician’s Certification of

Medical Necessity for Home Oxygen

Therapy and Supporting Regulations 42

CFR 410.38 and 42 CFR 424.5; Form

Number: HCFA–484 (OMB approval

#0938–0534); Use: To determine oxygen

is reasonable and necessary pursuant to

Medicare Statute, Medicare claims for

home oxygen therapy must be

supported by the treating physician’s

statement and other information

including estimate length of need (# of

months), diagnosis codes (ICD–9) and:

1. Results and date of the most recent

arterial blood gas PO2 and/or oxygen

saturation tests.

2. The most recent arterial blood gas

PO2 and/or oxygen saturation test

performed EITHER with the patient in a

chronic stable state as an outpatient, OR
64852 Federal Register / Vol. 62, No. 236 / Tuesday, December 9, 1997 / Notices

within two days prior to discharge from

an inpatient facility to home.

3. The most recent arterial blood gas

PO2 and/or oxygen saturation test

performed at rest, during exercise, or

during sleep.

4. Name and address of the physician/

provider performing the most recent

arterial blood gas PO2 and/or oxygen

saturation test.

5. If ordering portable oxygen,

information regarding the patient’s

mobility within the home.

6. Identification of the highest oxygen

flow rate (in liters per minute)

prescribed.

7. If the prescribed liters per minute

(LPM), as identified in item 6, are

greater than 4 LPM, provide the results

and date of the most recent arterial

blood gas PO2 and/or oxygen saturation

test taken on 4 LPM.

If the PO2 = 56–59, or the oxygen

saturation = 89%, then evidence of the

beneficiary meeting at least one of the

following criteria must be provided.

8. The patient having dependent

edema due to congestive heart failure.

9. The patient having cor pulmonale

or pulmonary hypertension, as

documented by P pulmonale on an EKG

or by an echocardiogram, gated blood

pool scan or direct pulmonary artery

pressure measurement.

10. The patient having a hematocrit

greater than 56%.

Form HCFA–484 obtains all pertinent

information and promotes national

consistency in coverage determinations;

Frequency: Other (as needed); Affected

Public: Individuals/households,

business or other for profit, and not for

profit institutions; Number of

Respondents: 300,000; Total Annual

Responses: 300,000; Total Annual

Hours Requested: 50,000.

To obtain copies of the supporting

statement, and any related forms

referenced above, E-mail your request,

including your address and phone

number, 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 designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: December 2, 1997.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Information

Technology Investment Management Group,

Division of HCFA Enterprise Standards.

[FR Doc. 97–32100 Filed 12–8–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Notice of

National Cancer Institute Director’s

Consumer Liaison Group Meeting

Notice is hereby given that the

National Cancer Institute will hold its

first public meeting of the Director’s

Consumer Liaison Group, beginning at

9:00 a.m. on December 17, 1997 and

ending at 3:00 p.m. on December 18,

1997 at the Pooks Hill Marriott,

Bethesda, MD. Seating is limited and

will be on a first-come, first-served

basis.

The National Cancer Institute (NCI),

the federal government’s primary

agency for cancer research, is bringing

together fifteen (15) consumer-advocates

to create a two-way street that enables

them to interact directly with the

scientific community at NCI on a wide

range of programs and issues. The 15-

member DCLG is made up of people

involved in cancer advocacy and who

reflect the breadth and diversity among

those whose lives are touched by

cancer. The DCLG will also help NCI to

widen the pool of qualified consumeradvocates who can be called upon to

serve on NCI advisory committees and

other groups.

The members are (in alphabetical

order):

Paula E. Bowen, Brooklyn, N.Y.

Susan Lowell Butler, Alexandria, Va.

Manuel H. Castillo, Dayton, Ohio

Kerry J. Dewey, Missoula, Mont.

M. Venus Gines, Lithonia, Ga.

Felicia Schanche Hodge, Berkeley, Calif.

Michael Katz, New York, N.Y.

Susan A. Leigh, Tucson, Ariz.

Ruth Chiang Lin, Short Hills, N.J.

Gena H. Love, Albuquerque, N.M.

Susan McCarthy, Vancouver, Wash.

Daniel M. Moore, Jr., Decatur, Ill.

Lillouise Rogers, Chicago, Ill.

Susan K. Stewart, Highland Park, Ill.

Brad Zebrack, Ann Arbor, Mich.

The majority of the newly appointed

DCLG members are cancer survivors,

but family members of cancer patients

and health professionals involved in

cancer advocacy are represented. The

cancer experience of the group includes

prostate, breast, kidney, ovarian,

cervical, lung, bladder, and brain

cancer, Hodgkin’s disease, leukemia,

sarcoma, and myeloma. The group

represents Asian American, Native

American, Hispanic, African American,

and non-Hispanic white persons, the

young and old, men and women, the

medically underserved, and people from

all geographic areas of the country, both

rural and urban. The constituencies

represented by the members include

advocacy organizations that represent

both specific cancers and all cancers.

DCLG members will serve three-year

terms. The three-fold purpose of the

DCLG will be to:

• Serve as a primary forum for

discussing issues and concerns and

exchanging viewpoints that are

important to the broad development of

NCI program and research priorities.

• Help develop and establish

processes, mechanisms, and criteria for

identifying appropriate consumer

advocates to serve on a variety of NCI

program and policy advisory

committees.

• Establish and maintain strong

collaborations between NCI and the

cancer advocacy community.

One purpose of this first meeting is to

decide how the group will do its work.

For example, how it will select a chair

and identify members who will serve in

the future. The DCLG will also discuss

how it will communicate internally and

with the broad advocacy community it

represents. In addition, the group will

begin discussion on several key issues

for the Institute. The most pressing

issues faced by cancer patients today, as

described in the candidates’

applications, include: Access to and

availability of reliable cancer

information; access to effective, highquality treatment, including clinical

trials; increased rehabilitation,

psychosocial support, and other

survivor concerns; and participation in

setting research priorities. NCI may also

begin issues to the attention of the

group.

Individuals who plan to attend the

meeting and need special assistance,

such as sign language interpretation or

other special accommodations, should

contact Elaine C. Lee, in the Office of

Liaison Activities, National Cancer

Institute, Building 31, Room 10A06; or

by calling telephone No. 301 594–3194

or sending a fax to 301 480–7558. For

additional information, contact Ms. Lee

at the above address.