Federal Register / Vol. 62, No. 165 / Tuesday, August 26, 1997 / Notices 45259

particular, the topical module will

provide end-point estimates for many of

the Healthy People 2000 Objectives. The

Basic Module of the new data system is

expected to be in the field at least until

2006. The total annual burden hours are

57,000.

Respondents

No. of

respondents

No. of

responses/

respondent

Avg. burden/response

(in hrs.)

Family Core

(adult family

member) .... 42,000 1 0.5

Adult Core

(sample

adult) .......... 42,000 1 0.5

Child Core

(sample

child) .......... 18,000 1 0.25

Prevention

Module

(sample

adult) .......... 42,000 1 0.25

Dated: August 20, 1997.

Wilma G. Johnson,

Acting Associate Director for Policy Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–22614 Filed 8–25–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Draft Document: Reporting of

Pregnancy Success Rates From

Assisted Reproductive Technology

Programs; Notice of Comment Period

AGENCY: Centers for Disease Control and

Prevention (CDC), Department of Health

and Human Services (DHHS).

ACTION: Notice; request for comment.

SUMMARY: This notice is a request for

comment and review of the draft

document for the Reporting of

Pregnancy Success Rates from Assisted

Reproductive Technology (ART)

Programs as required by the Fertility

Clinic Success Rate and Certification

Act of 1992 (FCSRCA).

DATES: This notice is effective for the

calendar year 1997 and beyond. In order

to report outcomes of pregnancies

during a calendar year, clinic specific

data will be collected through October

of the following calendar year (e.g.,

outcomes of pregnancies occurring

during calendar year 1997 will be

collected through October 1998). CDC

will publish its first annual report under

this notice in March 1999.

To ensure consideration, written

comments on this document must be

received on or before September 25,

1997.

ADDRESSES: Comments shall be

submitted to: George Walter, M.S.P.H.,

Women’s Health and Fertility Branch,

Division of Reproductive Health,

National Center for Chronic Disease

Prevention and Health Promotion,

Centers for Disease Control and

Prevention (CDC), Mailstop K–34, 4770

Buford Hwy, NE., Atlanta, Georgia

30341–3724.

FOR FURTHER INFORMATION CONTACT:

George Walter, M.S.P.H., telephone

(770) 488–5204, E–Mail Address:

GBW4@CDC.GOV.

SUPPLEMENTARY INFORMATION: Section

2(a) of Pub. L. 102–493 (42 U.S.C. 263a–

1) requires that each ART program shall

annually report to the Secretary through

the Centers for Disease Control and

Prevention—(1) pregnancy success rates

achieved by such ART program, and (2)

the identity of each embryo laboratory

used by such ART program and whether

the laboratory is certified or has applied

for such certification under this act.

Pub. L. 102–493, Section 8 (42 U.S.C.

263a–7) defines ‘‘assisted reproductive

technology’’ (ART) as ‘‘all treatments or

procedures which include the handling

of human oocytes or embryos, including

in vitro fertilization, gamete

intrafallopian transfer, zygote

intrafallopian transfer, and such other

specific technologies as the Secretary

may include in this definition, after

making public any proposed definition

in such manner as to facilitate comment

from any person (including any Federal

or other public agency).’’

The Secretary is directed in Section

2(b) to define pregnancy success rates

and ‘‘make public any proposed

definition in such a manner as to

facilitate comment from any person

during its development.’’

Section 2c states: In developing the

definitions under subsection (b), ‘‘the

Secretary shall consult with appropriate

consumer and professional

organizations with expertise in using,

providing, and evaluating professional

services and embryo laboratories

associated with assisted reproductive

technologies.’’

Section 6 requires the Secretary,

through the CDC, to annually ‘‘publish

and distribute to the States and the

public—pregnancy success rates

reported to the Secretary under section

2(a)(1) and, in the case of an assisted

reproductive technology program which

failed to report one or more success

rates as required under each section, the

name of each such program and each

pregnancy success rate which the

program failed to report.’’

CDC has prepared these proposed

reporting requirements after discussion

with representatives of the Society for

ART (a national professional association

of ART clinical programs), the American

Society for Reproductive Medicine (a

national society of professional

individuals who work with infertility

issues), the College of American

Pathologists (a national professional

association of pathologists having an

accreditation program for reproductive

laboratories), the American College of

Obstetricians and Gynecologists (a

national society of obstetricians and

gynecologists), RESOLVE (a national

consumer association of couples with

infertility diagnoses), and the New

England Patients’ Rights Group (a

regional consumer association

concerned with patients’ rights and

informed consent issues), as well as a

variety of individuals with expertise

and interest in this field.

This notice provides opportunity for

public review and comment (see

appendix).

Dated: August 20, 1997.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

Appendix: Notice for the Reporting of

Pregnancy Success Rates From Assisted

Reproductive Technology Programs

Introduction

This notice includes four sections:

I. Who Reports * * * describes who shall

report to CDC.

II. Description of Reporting Process * * *

describes the reporting system and process

for reporting by each ART clinic.

III. Proposed Data to be Reported * * *

includes the definition of terms used in the

reporting database. These definitions are

provided only for the purpose of clarity in

reporting data and are not intended to define

standards of medical care.

IV. Definitions * * * describes terms, and

how pregnancy success rates will be defined

and reported, and outlines the topics and

analyses that will be included in the annual

published reports, using the data collected in

the reporting database.

I. Who Reports

The Fertility Clinic Success Rate and

Certification Act of 1992 (FCSRCA)

requires that each assisted reproductive

technology program shall annually

report to the Secretary of the

Department of Health and Human

Services through the CDC pregnancy

success rates and the certification status

of its embryology laboratory.

The Society for Assisted Reproductive

Technology (SART), an affiliate of the
45260 Federal Register / Vol. 62, No. 165 / Tuesday, August 26, 1997 / Notices

*These items are currently collected by SART

and will be purchased by CDC.

American Society for Reproductive

Medicine (ASRM), maintains a national

database of cycle specific data reported

by each of its members. As a condition

of SART membership, each ART clinic

must submit clinic specific data to

SART and agree to on site date

validation site visits by SART.

CDC has reviewed the SART reporting

database and system and found that it

provides the necessary information to

publish an annual report as required by

the FCSRCA. Rather than duplicate

SART’s reporting system, and thereby

burden ART clinics and patients, CDC

will contract with the SART to obtain a

copy of their clinic specific database.

ART clinics that participate in the

ASRM/SART reporting system as

described in this notice, will be

considered to be in compliance with the

reporting requirements of FCSRCA.

Any ART program that is not a

member of SART shall contact CDC for

reporting information, instructions, and

fees charged (fees are for the purposes

of covering all costs associated with this

activity, including data collection,

processing, analysis, publication, and

administration.)

Contact George Walter, M.S.P.H.,

telephone (770) 488–5204.

II. Description of Reporting Process

A. Reporting Activities

SART issues a unique clinic code,

computer software for their database

reporting system, and all necessary

reporting instructions.

Each patient receiving ART in a clinic

is registered in the system with a

unique, clinic-assigned identifier and

should be entered into the reporting

database when her cycle is initiated.

Each cycle of each patient also receives

a unique cycle code for that patient. In

the reporting system, the patient is

identified by the center code, the patient

code, and the cycle code assigned by the

clinic; the patient’s name is not

included in the reporting database.

However, the individual clinics must be

able to use these codes to link every

cycle to a specific patient (see below).

The following patients are included in

the reporting database: (1) all women

undergoing ART, (2) all women

undergoing ovarian stimulation or

monitoring with the intention of

undergoing ART (this includes women

whose cycles are canceled for any

reason); (3) all women providing donor

oocytes, and (4) all women undergoing

an embryo thawing with the intention of

transferring cryopreserved embryos.

Clinic patitents will be informed

through consent forms that their cycle

specific data will be provided to the

CDC and that all personal identifiers

submitted to CDC in the SART data set

will be protected under the Privacy Act.

If a patient indicates that they do not

want their personal identifier reported,

the personal identifier will not be

included.

The CDC will retain a copy of each of

SART’s annual data files. These will be

used for epidemiologic analysis and for

the purpose of publishing an annual

report as required.

B. External Validation of Clinic Data

Every clinic will maintain a copy of

all information included in the

reporting database and must be able to

link each patient, cycle and occyte

retrieved from the reporting database to

the appropriate medical and laboratory

records for external validation activities.

On a periodic basis, ART clinical

programs will be subject to external

validation by SART of their reporting

activities which will include review by

appropriate professionals from outside

the clinic staff. This review may

include, but not be limited to,

examination of medical and laboratory

records, comparison of data in the

reporting database with data in the

medical record, and direct

communication with patients included

in the reporting database. Each patient

included in the reporting database

should be counseled that he or she may

be contacted by professional reviewers

as part of routine data validation and

asked to confirm information provided

in the database. Every patient should

have an informed consent document in

the medical record indicating that he or

she has been counseled concerning this

possible contact and has agreed or

refused to participate in the data

validation process.

C. Updating of Reporting Requirements

The field of ART is a rapidly

developing medical science. These

reporting requirements will be

periodically reviewed and updated as

new knowledge concerning ART

methods and techniques becomes

available. Such review will include

consultation with professional and

consumer groups and individuals, such

as the consultations obtained for this

initial notice. All notices for revision of

the reporting requirements will be

published in the Federal Register with

a comment period.

III. Proposed Data To Be Reported*

A. Clinic Information

• Name and address.

• Unique clinic ID number.

• Name(s) of embryo laboratory(s)

used by clinic.

• Years ART program has been

practicing under the above clinic name.

• Number of ART patients seen

during the reporting year.

• Total number of ART cycles

performed during the reporting year.

B. Patient information

1. Identification

• Patient ID number (e.g., medical

record number).

• Social Security Number.

• Date of birth.

• Race and ethnicity.

2. Reproductive History

• Gravidity.

• Prior total ART cycles (performed at

reporting clinic, plus all other clinics).

• Prior live births.

• ART cycles since last birth (if

applicable).

3. Cycle Specific Information

a. Identification

• Unique cycle specific number.

• Date ART initiated.

• Date ART canceled (if applicable).

• Date of Retrieval (if applicable).

• Date of transfer (if applicable).

b. Art Procedure Information

• Pre-treatment diagnosis (primary

and secondary).

• Type of ART performed.

• Use of surrogacy/gestational carrier.

• Stimulation medication with dosage

(if applicable).

• If canceled, reason for cancellation

(illness, small number or no follicles),

and if other forms of treatment such as

artificial insemination (therapeutic

insemination), timed intercourse, etc.,

are carried out.

• Number of oocytes retrieved (if

applicable).

• Sperm source (e.g., partner, donor,

or mixed) and motility.

• Use of micromanipulation for male

factor (e.g., ICSI, PZD, or SUZI).

• Use of assisted hatching.

• Number of embryos frozen.

• Number of fresh (or thawed)

embryos/oocytes transferred.

c. Outcome Information

• Results of pregnancy test and

ultrasound (when applicable).

• Type of pregnancy (e.g.,

biochemical, clinical or ectopic).

• Date and number (in sacs) of

pregnancy reduction.

• Outcome of clinical pregnancy

(spontaneous or induced abortion, live

birth, still birth).
Federal Register / Vol. 62, No. 165 / Tuesday, August 26, 1997 / Notices 45261

• Birth outcome (birth weight, birth

defects, neonatal death).

• Descriptions of complications

(hyper stimulation syndrome,

anesthesia complications,

hospitalization).

IV. Definitions

(Numbers in parentheses refer to

references at end of this document.)

ART—Assisted reproductive

technology, defined as all treatments or

procedures which include the handling

of human oocytes and sperm or embryos

for the purpose of establishing a

pregnancy. This includes, but is not

limited to, in vitro fertilization, gamete

intrafallopian transfer, zygote

intrafallopian transfer, embryo

cryopreservation, oocyte or embryo

donation, and gestational surrogacy(2).

ART Cycle—ART cycles can be

stimulated (use of ovulation induction)

or unstimulated (natural cycle (1). An

ART cycle is considered any cycle in

which: (1) ART has been used, (2) in

which the woman has undergone

ovarian stimulation or monitoring with

the intent of undergoing ART, or (3) in

the case of cryopreserved embryos, in

which embryos have been thawed with

the intent of transfer.

ART Program or Clinic—A legal entity

practicing under State law, recognizable

to the consumer, that provides assisted

reproductive technology to couples who

have experienced infertility or are

undergoing ART for other reasons. This

can be an individual physician or a

group of physicians who practice

together and share resources and

liability. If a program or clinic has

undergone significant staffing changes

such as changes in medical director, lab

director, or ownership, but maintains

the same or similar program name that

is recognizable to the consumer, the

practice is considered a continuation of

an existing program. This definition

precludes individual physicians who

practice independently from pooling

their results for purposes of data

reporting.

ASRM—American Society for

Reproductive Medicine.

Birth defect—Anomalies identified

within the first two weeks of life that

result in death or cause a serious

disability requiring surgical and/or

medical therapy (4). Specific anomalies

to be identified include cardiac defect,

cleft lip, cleft palate, genetic defect, and

limb defect.

Biochemical pregnancy—A positive

pregnancy test without the documented

presence of a gestational sac.

Canceled cycle—An ART cycle in

which ovarian stimulation or

monitoring has been carried out with

the intent of undergoing ART but which

did not proceed to oocyte retrieval, or in

the case of cryopreserved embryo

cycles, to the transfer of embryos.

Center code—An identification

number assigned to each ART clinical

program by the reporting database

operator.

Clinical pregnancy—An ultrasoundconfirmed gestational sac within the

uterus or the documented presence of

intrauterine products of conception.

Clinical pregnancies include all

gestational sacs regardless of whether or

not a heartbeat is observed or a fetal

pole is established. This definition

excludes ectopic pregnancy but

includes pregnancies which end in

spontaneous abortions, induced

abortions, and deliveries (3).

Clomiphene citrate—An ovulation

induction medication with the trade

name of Clomid or SeroPhene.

Complication—A medical

complication for the woman related to

ART procedures, such as reactions to

medications, anesthetic reaction,

postsurgical bleeding, or infection.

Cryopreservation—A technique to

preserve tissue, both ovarian and

testicular, through freezing.

Cycle code—The ART cycle number

for the particular patient. This code

should be unique for each cycle in the

same patient and is a separate number

from the patient code. The patient code

and cycle code together uniquely

identify each cycle of each patient

reported from the same clinic.

Cycle start date (cycle initiation

date)—The cycle start date is the day

that: (1) a patient in a stimulated cycle

begins ovarian stimulation; (2) a patient

in an unstimulated cycle begins cycle

monitoring with the expectation of

undergoing ART (including

cryopreserved embryo transfer); or (3) a

patient in a donor recipient or

cryopreserved embryo cycle begins

endometrial stimulation by exogenous

sex steroids (includes gestational

surrogacy). See also stimulated and

unstimulated cycles.

Donor embryo—An embryo derived

from the egg of a donor for transfer to

a recipient. (4)

Donor recipient cycle—A cycle in

which the patient receives a donor

embryo.

Donor oocyte cycle—A cycle in which

the patient donates some or all of her

oocytes to a recipient.

Down regulation—Use of a GnRH

agonist to effect ovarian suppression

prior to the initiation of ovarian

stimulation.

Ectopic pregnancy—A pregnancy in

which the fertilized egg implants

anywhere but in the uterine cavity

(usually in the fallopian tube, the ovary,

or the abdominal cavity) (3).

Embryo—The normally (2 pronuclei)

fertilized egg that has undergone one or

more divisions (8).

Embryo transfer—Introduction of

embryos into a woman’s uterus after in

vitro fertilization (3).

Endometriosis—The presence of

tissue resembling endometrium in

abnormal locations (locations outside

the uterus) such as the ovaries, fallopian

tubes, and abdominal cavity (4).

Fertilization—The penetration of the

egg by the sperm and fusion of genetic

materials to result in the development of

a fertilized egg (or zygote).

Flare protocol—Use of a GnRH

agonist starting with or after onset of

menses of the cycle being entered to

augment stimulation.

Fress zygotes or embryos—Zygotes or

embryos which have not been

cryopreserved. Such zygotes or embryos

may have been conceived using fresh or

frozen sperm.

FSH—Follicle stimulating hormone.

A hormone produced and released from

the pituitary that stimulates the ovary to

ripen a follicle for ovulation.

Gamete intrafallopian transfer

(GIFT)—An ART procedure that

involves removing eggs from the

woman’s ovary, combining them with

sperm, and immediately injecting the

eggs and sperm into the fallopian tube.

Fertilization takes place inside the

fallopian tube. (4)

GnRHa—Gonadotropin-releasing

hormone agonist (Lupron, Synarel

and ‘‘new’’ products (high purified or

recombinant)).

Gestational carrier—A woman who

gestates an embryo which did not

develop from her egg with the

expectation of returning the infant to its

genetic parents.

Gestational sac—A fluid-filled

structure that develops within the

uterus early in pregnancy (1).

Hatching (Assisted)—A

micromanipulation technique which

involves making a small opening in the

zona wall of the embryo to enhance

implantation (8).

Human chorionic gonadotrophin

(hCG)—A hormone secreted by the

products of conception derived from the

urine of pregnant women. HCG is used

to ripen the egg and trigger ovulation

(8).

Human menopausal gonadotrophin

(hMG)—A hormone extracted from the

urine of post-menopausal women. It is

rich in the hormones FSH (follicle

stimulating hormone) and LH

(luteinizing hormone) and is used to

stimulate follicular development and

ovulation (8).
45262 Federal Register / Vol. 62, No. 165 / Tuesday, August 26, 1997 / Notices

Intrauterine Insemination (IUI)—The

transfer of washed semen into a

woman’s uterus.

Intracytoplasmic sperm injection

(ICSI)—The placement of a single sperm

into the ooplasm of an oocyte by microoperative techniques.

In vitro fertilization (IVF)—A method

of assisted reproduction that involves

removing eggs from a women’s ovaries,

combining them with sperm in the

laboratory and, if fertilized, replacing

the resulting embryo into the women’s

uterus. (4)

Live birth—Any infant delivered with

signs of life (delivered with assigned 1

or 5 minute Apgar scores of 1 or

greater), at greater than or equal to 20

gestational weeks.

Male factor—A deficiency in quantity

and/or quality of sperm preventing

successful fertilization. SART defines

male factor as a sperm count of less than

20 million/milliliter and/or a motility of

40 percent or less. Frozen semen from

the male partner is classified by its

original fresh characteristics, not its

post-thaw values. If donor sperm are

used alone or in combination with male

partner’s sperm, the cycle is not

classified as male factor (3).

Multiple pregnancy—A pregnancy

with more than one fetus.

Neonatal death—Death of a live-born

infant before completion of the 28th day

of life.

Oocyte—The female reproductive

cell, also called an egg.

Oocyte donation—Removal of an egg

from one women for eventual transfer

into the fallopian tube (GIFT) or for a

ZIFT or IVF embryo transfer to another

woman. The donor relinquishes all

parental rights to any resulting

offspring, while the recipient women

retains all parental rights of any

resulting offspring.

Oocyte donor—A woman who

undergoes a donor oocyte cycle (see

donor cycle).

Oocyte retrieval—A procedure to

collect the eggs contained within the

ovarian follicles. This definition

includes procedures in which oocyte

recovery was attempted but not

successful (3).

Oocyte transfer—In GIFT (see

definition), transfer of retrieved eggs

into a woman’s fallopian tubes via

laparoscopy. Includes attempted

transfer, whether or not the transfer was

successful (3).

Ovarian monitoring—Monitoring the

development of ovarian follicles by

ultrasound and/or blood or urine tests.

Ovarian stimulation—A series of

drugs used to stimulate the ovary to

develop follicles and eggs (8).

Ovulatory dysfunction—A factor

causing reduced fecundity that is

associated with structural, anatomic, or

functional injury of one or both ovaries.

Ovulation induction—See stimulated

cycle.

Ovulation drug—See stimulated

cycle.

Pregnancy test—A blood test which

determines the level of human chorionic

gonadotropin; if it is elevated this

documents a pregnancy which can be

biochemical, ectopic or clinical.

Pregnancy reduction—A procedure in

which the number of gestational sacs is

reduced. It is used in women with

multiple gestations, usually three or

more, to decrease the number of fetuses

a woman carries and improve the

chances of survival of the remaining

fetus(es) and the delivery of a healthy

newborn(s).

SART—Society for Assisted

Reproductive Technology.

Sperm—The male reproductive cell

that has completed the process of

meiosis and morphological

differentiation.

Sperm concentration—The number of

sperm identified on microscopic

examination per milliliter of ejaculate.

Sperm donor—A man providing

sperm for the fertilization procedures of

a woman other than his sexual partner.

Spontaneous abortion (miscarriage)—

A pregnancy ending in spontaneous loss

of the embryo or fetus prior to

completion of 20 weeks of gestation.

Stillbirth—Infant delivered without

signs of life at 20 or greater weeks

gestation.

Stimulated cycle—An ART cycle in

which a women receives ovarian

stimulation, including the use of

clomiphene citrate, follicle stimulating

hormone, or human menopausal

gonadotrophin (4).

Thawed cycle—A cycle in which

embryos previously frozen are thawed

for embryo transfer.

Therapeutic or induced abortion—

Ending a pregnancy by using an

operative procedure to electively

terminate the pregnancy.

Tubal factor—A factor causing

reduced fecundity that is associated

with structural, anatomic, or functional

injury of one or both fallopian tubes.

Ultrasound—A technique for

visualizing the follicles in the ovaries

and the gestational sac or fetus in the

uterus, allowing the estimation of size.

Unexplained cause of infertility—

Infertility in which a couple has

received a comprehensive evaluation

without identification of an etiology for

the failure to conceive (7).

Unstimulated cycle—An ART cycle in

which the woman does not receive

ovulation stimulation, except for the

possible use of human chorionic

gonadotropin. Instead, only natural

follicular development occurs (3).

Uterine factor—A factor causing

reduced fecundity that is associated

with structural, anatomic, or functional

injury to the uterus.

Zygote—A normal (2 pronuclei)

fertilized egg before cell division begins

(1).

Zygote intra fallopian transfer

(ZIFT)—Eggs are collected and

fertilized, and the resulting zygote is

then transferred to the fallopian tube (4).

III. Content of Published Reports

These data can be used to provide a

useful picture of the national rates of

pregnancy in ART as well as clinicspecific rates (6). The annual report is

expected to have two components:

(1) A national component which will

provide a comprehensive picture of

success rates given a variety of factors

including age, diagnosis, type of ART

procedure, number of embryos

transferred, etc. This is possible because

the large number of cycles at the

national level allows accurate statistical

reporting of success rates, which is not

possible with the smaller number of

cycles carried out in individual clinics.

(2) A clinic-specific component which

will provide success rates for all

assisted reproductive technologies using

fresh embryos (IVF, GIFT, ZIFT, and

combinations of these), success rates for

cryopreserved embryos, success rates for

donor embryos and the percentage of

multiple pregnancies (twins and triplets

or greater). An age-adjusted rate will be

published with the 95 percent

confidence interval. When numbers

permit, success rates will also be

reported by specific age groups. In

addition, the clinic-specific component

will provide other information which

may be useful to the consumer, such as

the number of cycles carried out, the

percent distribution of types of ART, the

types of infertility problems the clinic

sees, and the average number of

embryos transferred per cycle.

Both components will be available to

the general public. Pregnancy success

rates will be defined and characterized

as described below. The following

information will be emphasized in the

published annual reports. As resources

allow, additional information may also

be published in supplemental reports.

1. The rate of live births after

completion of ART according to the

number of:

a. All ovarian stimulation or

monitoring procedures (cycle).

b. Oocyte retrieval procedures.
Federal Register / Vol. 62, No. 165 / Tuesday, August 26, 1997 / Notices 45263

c. Embryo (or zygote, or oocyte)

transfer procedures.

2. Frequency of:

a. Multiple gestations.

b. Cancellations.

3. The number of cycles carried out.

4. The average number of embryos

transferred per cycle.

5. The rates in (1), (2a), and (4) will

be categorized for:

a. ART using fresh embryos, those

using cryo-preserved embryos only, and

those using donor oocytes.

b. Age of woman at time of cycle (<35,

35–39 and >39).

6. To aid in the interpretation of rates,

the following information will be

included:

a. Clinic profile—What types of

services the clinic offers (e.g., surrogacy,

single women); the percentage of ART

procedures which are IVF, GIFT, ZIFT;

the percentage of procedures involving

ICSI; the percentage of multiple

pregnancies per transfer and the

percentage of these multiple

pregnancies which underwent selective

reduction; and the percent distribution

of causes of infertility.

b. Consumer-oriented explanation of

all medical and statistical terms used in

the report.

References

1. American Fertility Society. IVF & GIFT. A

Patient’s Guide to Assisted Reproductive

Technology. American Fertility Society.

Birmingham, Alabama, 1989.

2. The Fertility Clinic Success Rate and

Certification Act of 1992 (Public Law

102–493).

3. American Fertility Society/Society for

Reproductive Technology. Instructions

for SART Data Collection System, 1993.

American Fertility Society/Society for

Assisted Reproductive Technology,

Birmingham, Alabama, 1994.

4. American Fertility Society. Infertility: An

Overview. A Guide for Patients.

American Fertility Society, Birmingham,

Alabama, 1994.

5. American Fertility Society. Investigation of

the Infertile Couple. American Fertility

Society, Birmingham, Alabama, 1991.

6. Wilcox LS, Peterson HB, Haseltine FP,

Martin MC. Defining and Interpreting

Pregnancy Success Rates for In Vitro

Fertilization. Fertility and Sterility 1993;

60: 18–25.

7. Jones HW. On Reporting Pregnancies by

Assisted Reproductive Technology.

Fertility and Sterility 1993; 60: 759–761.

8. RESOLVE Assisted Reproductive

Technologies Workbook RESOLVE, Inc.,

Boston, MA, 1994.

[FR Doc. 97–22611 Filed 8–25–97; 8:45 am]

BILLING CODE 4163–18–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Proposed Information Collection

Activity; Comment Request Proposed

Projects

Title: Temporary Assistance for Needy

Families (TANF) Tribal Plan.

OMB No.: 0970–0157.

Description: This document consists

of an outline of how the Indian tribe’s

TANF program will be administered

and operated. It is used to determine

whether the plan is approvable and that

the Indian tribe is eligible to receive a

TANF grant.

Respondents: Tribal Govt.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of

responses

per respondent

Average

burden

hours per

response

Total burden hours

TANF Tribal Plan .............................................................................................................. 18 1 60 1,080

Estimated Total Annual Burden

Hours: 1,080.

In compliance with the requirements

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

Paperwork Reduction Act of 1995, the

Administration for Children and

Families is soliciting public comment

on the specific aspects of the

information collection described above.

Copies of the proposed collection of

information can be obtained and

comments may be forwarded by writing

to the Administration for Children and

Families, Office of Information Services,

Division of Information Resource

Management Services, 370 L’Enfant

Promenade, S.W., Washington, D.C.

20447, Attn: ACF Reports Clearance

Officer. All requests should be

identified by the title of the information

collection.

The Department specifically requests

comments 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)

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.

Consideration will be given to

comments and suggestions submitted

within 60 days of this publication.

Dated: August 20, 1997.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 97–22619 Filed 8–25–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–484, HCFA–R–200]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, HHS.

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 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;