64438 Federal Register / Vol. 60, No. 241 / Friday, December 15, 1995 / Notices

States participating in the marriage and

divorce components of the Vital

Statistics Cooperative Program (VSCP)

will no longer be obtained. This change

is being made to prioritize programs in

a period of tightened resource

constraints.

DATES: Written comments regarding

these changes in the collection of

marriage and divorce data must be

received on or before January 15, 1996.

ADDRESSES: Written comments can be

sent to the Centers for Disease Control

and Prevention (CDC), National Center

for Health Statistics, Attention: FR

Response, Division of Vital Statistics,

Room 840, 6525 Belcrest Road,

Hyattsville, MD 20782.

FOR FURTHER INFORMATION CONTACT:

Mary Anne Freedman, Director,

Division of Vital Statistics, NCHS, CDC,

telephone (301) 436–8951, ext. 112.

SUPPLEMENTARY INFORMATION: Viewed at

either the individual level or the

population level, marital status is a key

variable in health, demographic, and

policy research. As a result, data on

current marital status and on change in

marital status have been collected

through a variety of Federal surveys and

data systems. Among these systems are

health surveys conducted by NCHS, the

Current Population Survey conducted

by the U.S. Bureau of the Census, and

the records-based vital registration

system conducted as a cooperative

venture (the VSCP) between NCHS and

the States. Within the VSCP, current

marital status data are collected from

birth certificates in the birth registration

system, resulting, for example, in data

on out-of-wedlock births. Marital status

is also collected from death certificates

in the death registration system. Data on

change in marital status are obtained

from marriage and divorce certificates.

NCHS plans to discontinue payments

to the States and other vital registration

areas for the collection of detailed data

from marriage and divorce certificates,

but will continue to request counts of

marriages performed and divorces

granted from all vital registration areas

of the U.S. All other NCHS efforts to

collect marital status information,

including marital status for mothers on

birth certificates, will continue.

NCHS data systems are continually

being reviewed in light of resource

constraints to assure that efforts are

focused on the highest priority data

needs. At a time when policy issues

related to families are of great interest,

NCHS has exercised caution to assure

that data systems will be available to

support monitoring and research

interests in key priority areas. Over the

last year, NCHS has systematically

reviewed the availability and uses of

detailed data on marriages and divorces.

This review has led to the conclusion

that the data most needed for setting

policy (e.g., information on family

formation, out-of-wedlock births,

children living in single parent families)

can be obtained through other sources,

such as the birth registration system,

other NCHS surveys, and the Current

Population Survey.

The discontinuation of collection of

detailed data from marriage and divorce

certificates will result in a loss of data

to researchers who currently rely on this

data source for information on annual

changes in the collective marriage and

divorce behavior of the population,

including trends and differentials in the

propensity to marry, to divorce, and to

remarry after divorce or widowhood.

However, much of this information is

available on a five year cycle from the

June Marital History Supplement of the

Current Population Survey.

Long-standing concerns about the

completeness and quality of detailed

marriage and divorce data from the

VSCP were an important consideration

in reaching the conclusion to

discontinue payments to the States.

Although the United States Government

has collected marriage and divorce data

through various methods since 1867, it

was not until 1957 that a formal

Registration Area was created for

reporting detailed marriage data to

NCHS; a similar Registration Area was

created for divorces in 1958. These

Registration Areas include States with

adequate programs for collecting

marriage and divorce statistics and

which meet specific registration and

reporting criteria for participation. More

recently, NCHS has included marriage

and divorce statistics in the VSCP, a

contractual arrangement by which

NCHS provides support to the State

vital statistics programs and through

which NCHS receives vital statistics

data for analysis and dissemination at

the national level.

Working with State vital registration

offices and with various users of

marriage and divorce data, NCHS has

established standard certificates of

marriage and divorce. These certificates

contain selected data items about

marriages and divorces, and certain of

these items are required for admission

to the registration areas. Due to variation

in State laws on registration of marriage

and divorce, not all States obtain these

basic required items, and not all States

have central registration facilities for

marriages or divorces or both. At

present, 41 States, the District of

Columbia, Puerto Rico, and the Virgin

Islands participate in the Marriage

Registration Area and 31 States, the

District of Columbia, and the Virgin

Islands participate in the Divorce

Registration Area. Detailed data are

currently obtained from relatively small

systematic samples of marriage and

divorce records for these Areas.

Although this system has been in place

for many years, it has never been

completed. Detailed data represent

approximately 77 percent of marriages

in the nation and 49 percent of divorces.

For this reason, in addition to the

detailed data, NCHS obtains counts of

the number of marriages performed and

the number of divorces granted from all

States, the District of Columbia, Puerto

Rico, and the Virgin Islands.

Fiscal constraints on State vital

statistics programs have put stress on

state-level quality assurance programs.

As a result, in addition to the problem

of coverage completeness, the quality of

detailed marriage and divorce data has

deteriorated. This deterioration is

reflected mostly by the fact that, in some

States, the response rates for certain key

variables have fallen well below the

minimum level acceptable to NCHS.

These coverage and quality concerns,

the lack of identified resources to

upgrade the system, and the availability

of marital status data for high-priority

needs from other sources have led

NCHS, in consultation with data users,

to conclude that resources currently

devoted to the marriage and divorce

component of the VSCP should be

redirected to other priority uses.

Dated: December 8, 1995.

Claire V. Broome,

Deputy Director, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 95–30566 Filed 12–14–95; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

[Docket No. 95M–0394]

Datascope Corp.; Premarket Approval

of the VasoSeal Vascular Hemostasis

Device

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by

Datascope Corp., Montvale, NJ, for

premarket approval, under the Federal

Food, Drug, and Cosmetic Act (the act),

of the VasoSeal Vascular Hemostasis

Device (VHD). FDA’s Center for Devices

and Radiological Health (CDRH)

notified the applicant, by letter of
Federal Register / Vol. 60, No. 241 / Friday, December 15, 1995 / Notices 64439

September 29, 1995, of the approval of

the application.

DATES: Petitions for administrative

review by January 16, 1996.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Christopher M. Sloan, Center for

Devices and Radiological Health (HFZ–

450), Food and Drug Administration,

9200 Corporate Blvd., Rockville, MD

20850, 301–443–8243.

SUPPLEMENTARY INFORMATION: On

February 3, 1992, Datascope Corp.,

Montvale, NJ 07645, submitted to CDRH

an application for premarket approval of

the VasoSeal Vascular Hemostasis

Device. The device is a vascular

hemostasis device and is indicated for

use in reducing time to hemostasis at

the femoral arterial puncture site in

patients who have undergone diagnostic

angiography or percutaneous

transluminal coronary angioplasty

(PTCA) procedures using an 8 French or

smaller procedural sheath. The

VasoSeal VHD is also indicated for use

in PTCA patients when immediate

sheath removal is desired.

On May 8, 1995, the Circulatory

System Devices Panel of the Medical

Devices Advisory Committee, an FDA

advisory committee, reviewed and

recommended approval of the

application.

On September 29, 1995, CDRH

approved the application by a letter to

the applicant from the Director of the

Office of Device Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act (21 U.S.C.

360e(d)(3)) authorizes any interested

person to petition, under section 515(g)

of the act, for administrative review of

CDRH’s decision to approve this

application. A petitioner may request

either a formal hearing under part 12 (21

CFR part 12) of FDA’s administrative

practices and procedures regulations or

a review of the application and CDRH’s

action by an independent advisory

committee of experts. A petition is to be

in the form of a petition for

reconsideration under § 10.33(b) (21

CFR 10.33(b)). A petitioner shall

identify the form of review requested

(hearing or independent advisory

committee) and shall submit with the

petition supporting data and

information showing that there is a

genuine and substantial issue of

material fact for resolution through

administrative review. After reviewing

the petition, FDA will decide whether to

grant or deny the petition and will

publish a notice of its decision in the

Federal Register. If FDA grants the

petition, the notice will state the issue

to be reviewed, the form of the review

to be used, the persons who may

participate in the review, the time and

place where the review will occur, and

other details.

Petitioners may, at any time on or

before January 16, 1996, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: November 29, 1995.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 95–30610 Filed 12–14–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95M–0396]

Karl Storz Endoscopy-America, Inc.;

Premarket Approval of Storz Modulith

Lithotripter, Model SL20

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Karl

Storz Endoscopy-America, Inc.,

Kennesaw, GA, for premarket approval,

under the Federal Food, Drug, and

Cosmetic Act (the act), of the Storz

Modulith Lithotripter, Model SL20.

FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of February 17, 1995,

of the approval of the application.

DATES: Petitions for administrative

review by January 16, 1996.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT: John

H. Baxley, Center for Devices and

Radiological Health (HFZ–472), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2194.

SUPPLEMENTARY INFORMATION: On

November 24, 1993, Karl Storz

Endoscopy-America, Inc., Kennesaw,

GA 30144, submitted to CDRH an

application for premarket approval of

the Storz Modulith Lithotripter, Model

SL20. The device is an extracorporeal

shock wave lithotripter and is indicated

for use in the noninvasive fragmentation

of urinary calculi in the kidney and

upper ureter.

In accordance with the provisions of

section 515(c)(2) of the act (21 U.S.C.

360e(c)(2)) as amended by the Safe

Medical Devices Act of 1990, this

premarket approval application (PMA)

was not referred to the Gastroenterology

and Urology Devices Panel of the

Medical Devices Advisory Committee,

an FDA advisory committee, for review

and recommendation because the

information in the PMA substantially

duplicates information previously

reviewed by this panel.

On February 17, 1995, CDRH

approved the application by a letter to

the applicant from the Director of the

Office of Device Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act (21 U.S.C.

360e(d)(3)) authorizes any interested

person to petition, under section 515(g)

of the act, for administrative review of

CDRH’s decision to approve this

application. A petitioner may request

either a formal hearing under part 12 (21

CFR part 12) of FDA’s administrative

practices and procedures regulations or

a review of the application and CDRH’s