62322 Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Notices

FISCAL YEAR 1999 FEDERAL ALLOTMENTS TO STATES FOR SOCIAL

SERVICES—TITLE XX BLOCK

GRANTS—Continued

NORTH DAKOTA ............... 5,745,366

NO. MARIANA ISLANDS ... 82,069

OHIO ................................... 99,678,535

OKLAHOMA ........................ 29,449,462

OREGON ............................ 28,584,089

PENNSYLVANIA ................ 107,556,110

PUERTO RICO ................... 12,310,345

RHODE ISLAND ................. 8,832,162

SOUTH CAROLINA ............ 33,000,170

SOUTH DAKOTA ............... 6,530,447

TENNESSEE ...................... 47,461,721

TEXAS ................................ 170,648,082

UTAH .................................. 17,842,752

VERMONT .......................... 5,254,691

VIRGIN ISLANDS ............... 410,345

VIRGINIA ............................ 59,550,185

WASHINGTON ................... 49,361,974

WEST VIRGINIA ................. 16,290,433

WISCONSIN ....................... 46,034,301

WYOMING .......................... 4,291,182

Dated: November 5, 1997.

Donald Sykes,

Director, Office of Community Services.

[FR Doc. 97–30686 Filed 11–20–97; 8:45 am]

BILLING CODE 4184–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0446]

Determination That Desmopressin

Acetate Nasal Solution 0.01% (for

Refrigerated Storage) Was Not

Withdrawn From Sale for Reasons of

Safety or Effectiveness

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

determination that desmopressin acetate

(DDAVP Nasal Spray) nasal solution

0.01% (for refrigerated storage) was not

withdrawn from sale for reasons of

safety or effectiveness. This

determination will allow FDA to

approve abbreviated new drug

applications (ANDA’s) for desmopressin

acetate nasal solution 0.01% (for

refrigerated storage).

FOR FURTHER INFORMATION CONTACT:

Mary E. Catchings, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION: In 1984,

Congress enacted the Drug Price

Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

(the 1984 amendments) that authorized

the approval of duplicate versions of

drug products approved under an

ANDA procedure. ANDA sponsors

must, with certain exceptions, show that

the drug for which they are seeking

approval contains the same active

ingredient in the same strength and

dosage form as the ‘‘listed drug,’’ which

is a version of the drug that was

previously approved under a new drug

application (NDA). Sponsors of ANDA’s

do not have to repeat the extensive

clinical testing otherwise necessary to

gain approval of an NDA. The only

clinical data required in an ANDA are

data to show that the drug that is the

subject of the ANDA is bioequivalent to

the listed drug.

The 1984 amendments included what

is now section 505(j)(6) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

355(j)(6)), which requires FDA to

publish a list of all approved drugs.

FDA publishes this list as part of the

‘‘Approved Drug Products with

Therapeutic Equivalence Evaluations,’’

which is generally known as the

‘‘Orange Book.’’ Under FDA regulations,

drugs are withdrawn from the list if the

agency withdraws or suspends approval

of the drug’s NDA or ANDA for reasons

of safety or effectiveness, or if FDA

determines that the listed drug was

withdrawn from sale for reasons of

safety or effectiveness (21 CFR 314.162).

Regulations also provide that the agency

must make a determination as to

whether a listed drug was withdrawn

from sale for reasons of safety or

effectiveness before an ANDA that refers

to that listed drug may be approved

(§ 314.161(a)(1) (21 CFR 314.161(a)(1))).

FDA may not approve an ANDA that

does not refer to a listed drug.

In accordance with § 314.161(a)(1)

and (e), the agency initiated procedures

to determine whether desmopressin

acetate nasal solution 0.01% (for

refrigerated storage) was withdrawn

from sale for reasons of safety or

effectiveness. Desmopressin acetate

(DDAVP Nasal Spray) nasal solution

0.01% is the subject of approved NDA

17–922 held by Rhone-Poulenc Rorer

Pharmaceuticals, Inc. The original

formulation of desmopressin acetate

nasal solution 0.01% (NDA 17–922)

provided for refrigerated storage of the

product. On August 7, 1996, FDA

approved Rhone-Poulenc Rorer

Pharmaceutical, Inc.’s supplemental

application providing for reformulation

of desmopressin acetate nasal solution

0.01% for room temperature storage.

Rhone-Poulenc Rorer Pharmaceutical,

Inc., later withdrew the original

formulation, citing easier storage and

convenience with the reformulated

product.

FDA has reviewed its records and,

under § 314.161, has determined that

desmopressin acetate nasal solution

0.01% (for refrigerated storage) was not

withdrawn from sale for reasons of

safety or effectiveness. Accordingly, the

agency will maintain desmopressin

acetate nasal solution 0.01% (for

refrigerated storage) in the

‘‘Discontinued Drug Product List’’

section of the Orange Book. The

‘‘Discontinued Drug Product List’’

delineates, among other items, drug

products that have been discontinued

from marketing for reasons other than

safety or effectiveness. ANDA’s that

refer to desmopressin acetate nasal

solution 0.01% (for refrigerated storage)

may be approved by the agency.

Dated: November 14, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–30614 Filed 11-20-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0289]

Content and Format of Labeling for

Human Prescription Drugs; Pregnancy

Labeling; Public Hearing; Reopening

of Comment Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; reopening of comment

period.

SUMMARY: The Food and Drug

Administration (FDA) is reopening the

comment period following its

September 12, 1997, public hearing

until January 12, 1998. This public

hearing, which was announced in the

Federal Register of July 31, 1997 (62 FR

41061), focused on requirements for the

content and format of the pregnancy

subsection of labeling for human

prescription drugs. The comment period

closed on November 12, 1997. This

action is being taken in response to the

request of the Pharmaceutical Research

and Manufacturers of America for

additional time to prepare comments

because of the complexity and

importance of the issues raised by

pregnancy labeling.

DATES: Written comments by January 12,

1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug
Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Notices 62323

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Rose

E. Cunningham, Center for Drug

Evaluation and Research (HFD–6), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

6779.

SUPPLEMENTARY INFORMATION: In the

Federal Register of July 31, 1997 (62 FR

41061), FDA announced that it would

be holding a public hearing on

September 12, 1997, concerning the

requirements for the content and format

of the pregnancy subsection of labeling

for human prescription drugs. The

public hearing was intended to elicit

comments on the practical utility,

effects, and limitations of the current

pregnancy labeling categories in order to

help the agency identify the range of

problems associated with the categories

and to identify and evaluate options that

might address identified problems.

Interested persons were given until

November 12, 1997, to submit written

comments on these issues. Because of

the complexity and importance of the

issues raised by pregnancy labeling, the

Pharmaceutical Research and

Manufacturers of America has requested

an additional 60 days to prepare

comments.

Interested persons may, on or before

January 12, 1998, submit to the Dockets

Management Branch (address above)

written comments on this subject. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with Docket No. 97N–0289.

Received comments may be seen in the

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

Monday through Friday.

Dated: November 13, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–30561 Filed 11–20–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Antiviral Drugs Advisory Committee;

Notice of Subcommittee 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). The meeting will be open to the

public.

Name of Committee: Subcommittee

meeting of the Antiviral Drugs Advisory

Committee on immunosuppressive

drugs. General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues. Date and Time: The meeting will be

held on January 14, 1998, 8:30 a.m. to

5 p.m.

Location: Quality Suites, Potomac

Ballroom, Three Research Ct., Rockville,

MD.

Contact Person: Rhonda W. Stover or

John B. Schupp, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–5455, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12531.

Please call the Information Line for upto-date information on this meeting. Agenda: On January 14, 1998, the

subcommittee will discuss new drug

application (NDA) 50–722, CellCept

(mycophenolate mofetil), Syntex, USA,

Inc., for immunosuppression following

cardiac transplantation. Procedure: 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 January 7, 1998. Oral

presentations from the public will be

scheduled between approximately 11

a.m. and 12 m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before January 7, 1998, 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. Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: November 14, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–30705 Filed 11–20–97; 8:45 am]

BILLING CODE 4160–01–F

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). The meeting will be open 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

regulatory issues.

Date and Time: The meeting will be

held on December 11, 1997, 8 a.m. to 6

p.m., and December 12, 1997, 8 a.m. to

3:30 p.m.

Location: DoubleTree Hotel, Plazas I,

II, and III, 1750 Rockville Pike,

Rockville, MD.

Contact Person: Linda A. Smallwood,

Center for Biologics Evaluation and

Research (HFM–350), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852, 301–827–3514, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12388. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On December 11, 1997, the

committee will discuss and provide

recommendations on the issue of FDA’s

donor deferral policy regarding men

who have had sex with another man

even one time since 1977.

On the morning of December 12,

1997, the committee will sit as a

medical device panel and make

recommendations on the issue of in

vitro diagnostic detection of human

immunodeficiency virus (HIV) viral

load, sponsor, Roche Molecular

Systems. In the afternoon, the

Committee will hear an informational

presentation on hepatitis C virus (HCV)

risk in sexual partners of positive

individuals.

Procedure: 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 December 1, 1997. Oral

presentations from the public will be

scheduled between approximately 1

p.m. and 4:30 p.m., on December 11,

1997, and between approximately 10

a.m. and 11 a.m. and 2 p.m. and 3 p.m.,

on December 12, 1997. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before December 1, 1997, 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