14918 Federal Register / Vol. 62, No. 60 / Friday, March 28, 1997 / Notices

Pharmaceutical equivalents and

pharmaceutical alternatives are defined

similarly in the Orange Book. Under

these definitions, a tablet and a capsule

cannot be rated as therapeutic

equivalents in the Orange Book even if

they have been demonstrated to be

bioequivalent.

FDA has received two citizen

petitions asking the agency to revise the

current policy that does not permit

tablets and capsules to be rated as

therapeutically equivalent. Kleinfeld,

Kaplan and Becker (Kaplan) submitted a

petition dated August 11, 1995, that

asks FDA to take the following actions:

(1) Revise the Orange Book to specify

therapeutic equivalence evaluations for

products that contain the same active

ingredient, but are in a different solid

oral dosage form (i.e., tablets and

capsules); (2) change the Orange Book

designations ‘‘Tablet, Oral’’ and

‘‘Capsule, Oral,’’ to ‘‘Solid, Oral’’; and

(3) change the definitions of

‘‘Pharmaceutical equivalents’’ and

‘‘Pharmaceutical alternatives’’ in FDA’s

regulations in 21 CFR 320.1(c) and (d)

and in the Orange Book to accommodate

the requested changes. The petition

suggests, as an alternative, that FDA

could rule that tablets and capsules are

the same dosage form (i.e., solid oral)

and are thus pharmaceutical

equivalents. Under the latter approach,

grant of a suitability petition (under

section 505(j)(2)(C) of the act (21 U.S.C.

355(j)(2)(C)) and 21 CFR 314.93) would

not be a prerequisite for FDA to approve

a tablet form of a capsule product, or

vice versa.

The National Association of

Pharmaceutical Manufacturers (NAPM)

submitted a citizen petition dated

August 27, 1996, requesting that ‘‘FDA

deem all solid oral dosage form drug

products (e.g., tablets and capsules) as

the same dosage form, which, upon a

showing of bioequivalence, will be

considered in all respects to be

‘pharmaceutical equivalents.’’’ NAPM

argues that tablets and capsules are

‘‘more properly regarded as a single

dosage form, i.e., solid oral dosage

forms.’’ Both petitions assert that there

is no scientific basis for distinguishing

between tablets and capsules that have

been demonstrated to be bioequivalent.

Recently, the issue of whether tablets

and capsules can be listed in the Orange

Book as therapeutically equivalent has

taken on added significance. Some

innovator firms, whose period of

marketing protection (either through

patent or exclusivity) is about to expire,

have succeeded in delaying generic

competition by, for example, voluntarily

withdrawing the new drug application

(NDA) for the tablet formulation of a

product and submitting a second NDA

for the drug product in capsule form. In

such a case, if there are already filed

abbreviated new drug applications

(ANDA’s) for the tablet product, these

ANDA’s cannot be approved

immediately upon expiration of the

innovator’s period of market protection.

Before these ANDA’s can be approved,

an interested party must file a petition

asking the agency to determine whether

the innovator product was withdrawn

for reasons of safety or effectiveness.

The agency must then determine that

the product was not withdrawn for

these reasons, publish that

determination, and relist the product in

the Orange Book. Even after a

withdrawn product has been relisted in

this way, generic competition may still

be affected. For example, if physicians

continue to write prescriptions by brand

name rather than by generic name,

substitution of the generic tablet for the

brand name capsule may not be

permitted under the applicable State

drug product selection statute.

FDA is soliciting public comment on

the two citizen petitions discussed

above. Among the questions the agency

would particularly like to see addressed

are the following:

1. Should any potential change in

current FDA policy be limited to

permitting bioequivalent tablets and

capsules to be listed as therapeutic

equivalents in the Orange Book, or

should FDA regard tablets and capsules

as the same (i.e., solid oral) dosage

form?

2. What would be the implications of

regarding all tablets and capsules as the

same dosage form?

3. Is there a sound scientific basis for

the current distinction between tablets

and capsules?

4. What would be the impact on

patients of rating bioequivalent tablets

and capsules as therapeutically

equivalent, or of adopting the term

‘‘solid oral’’ as a dosage form? Are there

reasons for some patients or health care

practitioners to prefer either tablets or

capsules?

5. How would listing tablets and

capsules as therapeutic equivalents in

the Orange Book affect current

substitution practices under State drug

product selection statutes? What would

be the impact on drug selection by

formularies?

6. What would be the economic

impact of various proposed changes?

7. How would FDA action in this area

relate to United States Pharmacopoeia

(USP) monographs?

Interested persons may, on or before

June 26, 1996, submit to the Dockets

Management Branch (address above)

written comments regarding this notice.

Two copies of any comments are to be

submitted, except that individuals may

submit one copy. Requests and

comments are to be identified with the

docket numbers found in brackets in the

heading of this document. The NAPM

and Kaplan petitions and received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday. Copies of the

citizen petitions may be requested in

writing from the Freedom of

Information Office (HFI–35), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857.

Dated: March 21, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–7912 Filed 3–27–97; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

(1965, 2649, 5011A–U6, 5011B–U6)

Agency Information Collection

Activities: Proposed Collection;

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, is publishing the

following summary of proposed

collections for public comment.

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.

1. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Request for

Hearing—Part B Medicare Claim, 42

CFR 405.821; Form No.: HCFA–1965;

Use: Section 1869 of the Social Security

Act authorizes a hearing for any

individual who is dissatisfied with any

determination and amount of benefit

paid. This form is used so that a party

may request a hearing by a Hearing

Officer because the review
Federal Register / Vol. 62, No. 60 / Friday, March 28, 1997 / Notices 14919

determination failed to satisfy the

appellant. Frequency: Annually,

Quarterly and Monthly; Affected Public:

Individual or Households, and Not for

profit institutions; Number of

Respondents: 55,000; Total Annual

Hours: 9,167.

2. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Request for

Reconsideration of Part A Insurance

Benefits, 42 CFR 405.711; Form No.:

HCFA–2649; Use: Section 1869 of the

Social Security Act authorizes a hearing

for any individual who is dissatisfied

with the intermediary’s Part A

determination or the amount paid. This

form is used by a party to request a

reconsideration of the initial

determination. Frequency: Annually,

Quarterly and Monthly; Affected Public:

Individuals or Households, and Not for

profit institutions; Number of

Respondents: 62,000; Total Annual

Hours: 15,500.

3. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Request for Part

A Medicare Hearing by an

Administrative Law Judge, 42 CFR

498.40; Form No.: HCFA–5011A–U6;

Use: Section 1869 of the Social Security

Act authorizes a hearing for any

individual who is dissatisfied with the

intermediary’s Part A determination or

the amount paid. This form is used by

the beneficiary or other qualified

appellant to request a hearing by an

Administrative Law Judge if the

reconsideration determination fails to

satisfy the appellant. Frequency:

Annually, Quarterly and Monthly;

Affected Public: Individuals or

Households, and Not for profit

institutions; Number of Respondents:

10,000; Total Annual Hours: 2,500.

4. Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Request for Part

B Medicare Hearing by an

Administrative Law Judge; Form No.:

HCFA–5011B–U6; Use: Section 1869 of

the Social Security Act authorizes a

hearing for any individual who is

dissatisfied with the carrier’s Part B

determination or the amount paid. This

form is used by the beneficiary or other

qualified appellant to request a hearing

by an Administrative Law Judge if the

hearing officer’s decision fails to satisfy

the appellant. Frequency: Annually,

Quarterly and Monthly; Affected Public:

Individuals or Households, and Not for

profit institutions; Number of

Respondents: 10,000; Total Annual

Hours: 2,500.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s WEB SITE ADDRESS at http://

www.hcfa.gov/regs/prdact95.htm, or to

obtain the supporting statement and any

related forms, 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 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Financial and Human

Resources, Management Analysis and

Planning Staff, Attention: Louis Blank,

Room C2–26–17, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: March 19, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources.

[FR Doc. 97–7892 Filed 3–27–97; 8:45 am]

BILLING CODE 4120–03–P

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of Title 35, United

States Code, as amended by the

Paperwork Reduction Act of 1995,

Public Law 104–13), the Health

Resources and Services Administration

(HRSA) will publish periodic

summaries of proposed projects being

developed for submission to OMB under

the Paperwork Reduction Act of 1995.

To request more information on the

proposed project or to obtain a copy of

the data collection plans, call the HRSA

Reports Clearance Officer on (301) 443–

1129.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Project: AIDS Drug Assistance

Program [ADAP]: Monthly Client

Utilization and Program Expenditure

Assessment Project—NEW

State AIDS Drug Assistance Programs

[ADAP], funded under Title II of the

Ryan White Comprehensive AIDS

Resources Emergency [CARE] Act

Amendments of 1996 [Pub. L. 104–146],

are designed to provide low income,

uninsured, and underinsured

individuals with access to HIV/AIDS

medications that prevent serious

deterioration of health arising from HIV

disease, including prevention and

treatment of opportunistic diseases.

Due to the increasing need for

pharmaceuticals among uninsured and

underinsured low-income individuals

who are HIV+ or diagnosed with AIDS,

and recognizing the importance of

program planning and budget

forecasting to maximize resources, the

Division of HIV Services [DHS], Health

Resources and Services Administration

[HRSA], proposes to collect relevant

client utilization data and program

expenditure information on a voluntary

monthly reporting basis from State

ADAPs. This effort is designed to assist

Title II grantees, State ADAPs, the DHS/

HRSA funding agency staff, and policy

makers at both the federal and State

level to better understand the level of

client need for medications that the

programs are functioning under and the

resources used to meet the needs, and

to provide indicators of where future

action may be required and the most

appropriate response(s).

A report is proposed that will collect

time-specific data for the number of

enrolled clients, the number of clients

served, the level of funding expended,

and the prices of five to seven specified

pharmaceuticals dispensed by each

program. In addition, the report will

provide a forum for tracking the most

current changes in each State ADAP

with respect to available funding,

eligibility criteria, clinical guidelines,

and formulary changes. The individual

State reports will be compiled into

summary reports and distributed back to

grantees and State ADAPs on a monthly

basis, as well as available for use by

HRSA and the Office of Management

and Budget. These results will be used

to guide program planning, to formulate

budget recommendations, and to

monitor the balance between available

resources and State needs. The burden

estimates are as follows: