5548 Federal Register / Vol. 69, No. 24 / Thursday, February 5, 2004 / Notices 

Atlanta, GA 30328, Telephone (770) 395–

3900. 

Status: Portions of the meeting will be 

closed to the public in accordance with 

provisions set forth in Section 552b(c) (4) and 

(6), Title 5 U.S.C., and the Determination of 

the Director, Management Analysis and 

Services Office, CDC, pursuant to Public Law 

92–463. 

Matters To Be Discussed: The meeting will 

include the review, discussion, and 

evaluation of applications received in 

response to Program Announcement Number 

04064. 

For Further Information Contact: Beth 

Wolfe, Resource Funding Analyst, National 

Center for HIV, STD, and TB Prevention, 

CDC, 1600 Clifton Road, NE., MS–E07, 

Atlanta, GA 30333, Telephone (404) 639–

8531. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both CDC and the Agency for Toxic 

Substances and Disease Registry.

Dated: January 30, 2004. 

Alvin Hall, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention.

[FR Doc. 04–2397 Filed 2–4–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Prospective Grant of Exclusive 

License: Diagnostics of Fungal 

Infections

AGENCY: Technology Transfer Office, 

Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services.

ACTION: Notice.

SUMMARY: This is a notice in accordance 

with 35 U.S.C. 209(e) and 37 CFR 

404.7(a)(1)(i) that the Centers for Disease 

Control and Prevention (CDC), 

Technology Transfer Office, Department 

of Health and Human Services (DHHS), 

is contemplating the grant of a 

worldwide, limited field of use, 

exclusive license to practice the 

inventions embodied in the patent 

application referred to below to TNB 

Laboratories, Inc. (TNB) having a place 

of business in St. Johns, Newfoundland. 

The patent rights in these inventions 

have been assigned to the government of 

the United States of America. The 

patent application to be licensed is: 

Title: ‘‘Latent Human Tuberculosis 

Model, Diagnostic Antigens, and 

Methods of Use,’’ U.S. Patent 

Application Serial No.: 10/250,930 

(TBC). 

Status: Pending. 

Issue Date: N/A. 

The prospective exclusive license will 

be royalty-bearing and will comply with 

the terms and conditions of 35 U.S.C. 

209 and 37 CFR 404.7. 

Technology 

This technology adds a new level of 

specificity in the identification of 

Tuberculosis. It can be incorporated into 

a device to diagnose Latent Human 

Tuberculosis.

ADDRESSES: Requests for a copy of this 

patent application, inquiries, comments, 

and other materials relating to the 

contemplated license should be directed 

to Andrew Watkins, Director, 

Technology Transfer Office, Centers for 

Disease Control and Prevention (CDC), 

4770 Buford Highway, Mailstop K–79, 

Atlanta, GA 30341, telephone: (770) 

488–8610; facsimile: (770) 488–8615. 

Applications for a license filed in 

response to this notice will be treated as 

objections to the grant of the 

contemplated license. Only written 

comments and/or applications for a 

license which are received by CDC 

within sixty days of this notice will be 

considered. Comments and objections 

submitted in response to this notice will 

not be made available for public 

inspection, and, to the extent permitted 

by law, will not be released under the 

Freedom of Information Act, 5 U.S.C. 

552. A signed Confidential Disclosure 

Agreement (available under Forms @ 

http://www.cdc.gov/tto) will be required 

to receive a copy of any pending patent 

application.

Dated: January 29, 2004. 

Joseph R. Carter, 

Deputy Chief Operating Officer, Centers for 

Disease Control and Prevention.

[FR Doc. 04–2396 Filed 2–4–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Reporting of Pregnancy Success Rates 

From AssistedReproductive 

Technology Programs

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (DHHS).

ACTION: Notice.

SUMMARY: The CDC is tasked with 

implementing the Fertility Clinic 

Success Rate and Certification Act of 

1992 (FCSRCA), Public Law 102–493. 

As mandated by this law CDC publishes 

annual reports of pregnancy success 

rates from ART clinics and embryo 

laboratory certification status of these 

clinics. Section 2(a) of Public Law 102–

493 (42 U.S.C. 263a –1) requires that 

each assisted reproductive technology 

(ART) program shall annually report to 

the Secretary, through the Centers for 

Disease Control and Prevention, (a) 

pregnancy success rates achieved by 

such ART programs, and (b) the identity 

of each embryo laboratory used by such 

ART programs, and whether the 

laboratory is certified or has applied for 

such certification under this act. Section 

(6) states that the Secretary, through the 

CDC, shall 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 first implemented the FCSRCA 

in 1997, and has obtained and 

published data for ART procedures 

performed in 1995, 1996, 1997, 1998, 

1999 and 2000. Currently, CDC has a 

contract with the Society for Assisted 

Reproductive Technology (SART) to 

annually obtain a copy of their clinicspecific database. The existing contract 

will be used to obtain and publish data 

for ART procedures performed in 2001, 

2002 and 2003. Details on the current 

process are outlined in the September 1, 

2000 Federal Register notice (Volume 

65, No. 171, pages 53310–53316). 

CDC is currently in the process of 

selecting a contractor for the 2004, 2005, 

2006, 2007, and 2008 data reporting 

years. We anticipate awarding the 

contract in February, 2004. Based on 

that timeframe, we anticipate that the 

data collection system for 2004 data 

reporting will be available to clinics in 

summer, 2004. The new contract to be 

awarded will cover clinic tracking, data 

collection and quality assurance and 

validation processes for ART procedures 

performed in 2004, 2005, 2006, 2007 

and 2008. The data collection process is 

expected to be similar to the current 

data collection process (see September 

1, 2000 Federal Register notice, Volume 

65, No. 171, pages 53310–53316). 

Under the new contract, the 

contractor shall furnish all personnel, 

facilities, equipment, supplies, and 

materials necessary to assist CDC to 

produce and publish an annual report of 

pregnancy success rates and embryo 

laboratory certification status, as 

Federal Register / Vol. 69, No. 24 / Thursday, February 5, 2004 / Notices 5549

mandated by the Fertility Clinic Success 

Rate and Certification Act of 1992. 

(FCSRCA), Public Law 102–493. The 

Contractor shall meet the following 

requirements:

a. The contractor shall track all clinics 

performing ART in the United States 

and its territories that are known to be 

in operation for each reporting year and 

track all clinic reorganizations and 

closings. 

b. The contractor shall develop a 

standardized data collection system, 

subject to Office of Management and 

Budget (OMB) requirements, that 

appropriately collects all specified data 

from clinics.

c. The contractor shall implement a 

quality assurance system each year to 

ensure that the data delivered to CDC 

are of acceptable quality and 

completeness. 

d. The contractor shall distribute the 

data collection software, along with 

instructions, to all clinics by preset 

deadlines. 

e. The contractor shall provide 

ongoing technical assistance to each site 

as needed by developing, implementing, 

and maintaining a Web site and 

telephone help line for technical 

assistance in all data collection issues. 

f. The contractor shall deliver to the 

CDC, preliminary and final clinic and 

cycle specific data for each reporting 

year. The contractor shall deliver all 

necessary documentation pertaining to 

the annual data sets. 

g. The contractor shall provide: (1) A 

listing of all assisted reproductive 

technology clinics that are included in 

the clinic and cycle specific datasets 

each reporting year; and, (2) a listing of 

all assisted reproductive technology 

clinics that were performing assisted 

reproductive technology cycles and 

were thus required to report data under 

FCSRCA, but failed to report such data 

to the contractor. The lists of reporting 

and non-reporting clinics shall include 

all clinics known to be in operation 

during a given reporting year. 

h. Each year, the contractor shall 

prepare and describe a data validation 

quality assurance plan in conjunction 

with the CDC. The contractor shall 

perform data validation site visits, enter 

the data collected during these visits 

into an electronic data system, and 

provide both the electronic datafile and 

a hard copy of all abstraction forms to 

the CDC.

The amount and type of data collected 

will be similar to the current system 

requirements and will include clinic 

information, patient demographic 

information, patient history, ART cycle 

information, and ART outcome 

information. A detailed listing of 

current data elements and definitions 

for data to be collected are outlined in 

the Federal Register notice (see

September 1, 2000 Federal Register

notice, Volume 65, No. 171, pages 

53310–53316).

The current database system is based 

on Microsoft Access. In this new 

contract, CDC will require that the 

contractor develop a new database 

system. The database system developed 

under this new contract must have the 

capability to record data for every 

treatment cycle of ART initiated, 

convert collected data to a database 

such as Microsoft Access (and 

ultimately the database must be 

converted into SAS System Version 8.0 

or later). CDC will also require that the 

database developed include all 

programming necessary to take the data 

entered for each ART cycle initiated and 

compute all statistics needed for 

presentation in the report. The 

contractor will submit two datasets to 

CDC—one organized such that each 

ART cycle initiated is a unique 

observation, and one organized such 

that summary statistics by each clinic is 

a unique observation. 

Each ART program should be aware 

that the Paperwork Reduction Act is 

applicable to this data collection. Under 

the Paperwork Reduction Act of 1995, a 

Federal agency shall not conduct or 

sponsor a collection of information from 

ten or more persons other than Federal 

employees, unless the agency has 

submitted a Standard Form 83, 

Clearance Request, to the Director of the 

Office of Management and Budget 

(OMB), and OMB has approved the 

collection of information. A person is 

not required to respond to a collection 

of information unless it displays a 

currently valid OMB control number. 

CDC has obtained OMB approval to 

collect this data under OMB control No. 

0920–0556. 

Currently, each ART program must 

use the required database system 

(developed by SART) to enter and 

submit data. Under the new contract, 

CDC will continue to require a single 

data collection system (to be developed 

by the contractor). In addition, each 

ART program currently submits its 

dataset output from the required 

software to the contractor at a central 

site. The contractor then compiles all 

the datasets from specific sites into a 

single dataset. That requirement will 

continue. 

Currently, all ART programs reporting 

their data are subject to an annual 

external validation of their data 

collection and reporting activities by 

appropriately trained professionals from 

outside the clinic staff. This review 

includes but is not limited to 

examination of medical and laboratory 

records and comparison of data in the 

reporting database with the data in the 

medical record. External validation will 

continue with the new contract. 

Every clinic will maintain a copy of 

all information included in the 

reporting database and must be able to 

link each patient, cycle and oocyte 

retrieved from the reporting database to 

the appropriate medical and laboratory 

records for external validation activities. 

The new contractor will provide the 

necessary personnel to perform the 

validation visits. 

ART success rates will be similar to 

those currently presented in the annual 

reports and will be defined and 

characterized as described below: 

Success rates for fresh, nondonor 

cycles will be defined as—

1. The rate of pregnancy after 

completion of ART according to the 

number of: 

• All ovarian stimulation or 

monitoring procedures. 

2. The rate of live birth after 

completion of ART according to the 

number of: 

a. All ovarian stimulation or 

monitoring procedures. 

b. Oocytes retrieval process. 

c. Embryo (or Zygote, or oocyte) 

transfer procedures.

3. The rate of singleton live birth after 

completion of ART according to the 

number of:

a. All ovarian stimulation or 

monitoring procedures. 

b. Embryo (or zygote, or oocyte) 

transfer procedures.

Success rates for cycles using thawed 

embryos and cycles using donor oocytes 

or embryos will be defined as—

4. The rate of live birth after 

completion of ART according to the 

number of:

• Embryo (or zygote, or oocyte) 

transfer procedures.

5. The rate of singleton live birth after 

completion of ART according to the 

number of:

• Embryo (or zygote, or oocyte) 

transfer procedures.

Reporting requirements, data 

elements, definitions, and success rates 

will be periodically reviewed and 

updated as new knowledge concerning 

ART methods and techniques becomes 

available. 

Until a new contract has been 

awarded, ART programs are advised to 

refrain from entering 2004 data into the 

current data collection system. CDC will 

continue to provide information to all 

5550 Federal Register / Vol. 69, No. 24 / Thursday, February 5, 2004 / Notices 

ART programs regarding the status of 

the new contract and future years’ data 

collection activities as information 

becomes available.

FOR FURTHER INFORMATION CONTACT:

Victoria Wright, Assisted Reproductive 

Technology Epidemiology Unit at (770) 

488–6370.

Dated: January 29, 2004. 

Joseph R. Carter, 

Deputy Chief Operating Officer, Centers for 

Disease Control and Prevention.

[FR Doc. 04–2395 Filed 2–4–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Grants Application Data 

Summary Administration for Native 

Americans Language Application 

Information. 

OMB: No.: New collection. 

Description: Grants Application Data 

Summary (GADS) information is 

collected as part of a grant application. 

The GADS provides information used to 

prepare the legislatively mandated 

annual report to Congress on the status 

of American Indians, Native Alaskans, 

Native Hawaiians and Pacific Islander 

communities. 

The purpose of this information 

collection is to collect information from 

applicants that the Administration for 

Native Americans can use for more 

accurate reporting to the Administration 

for Children and Families and to 

Congress on the status of American 

Indians, Native Alaskans, Native 

Hawaiians and Pacific Islander 

communities. This information 

collection is conducted in accordance 

with 42 USC 2991b–2(4) of the Native 

American Programs Act of 1974, as 

amended. 

Respondents: Tribal governments, 

native non-profits, tribal colleges & 

universities. 

Annual Burden Estimates:

Instrument Number of

respondents 

Number of responses per 

respondent 

Average burden hours per 

response 

Total burden 

hours 

Language GADS Form .................................................................................... 650 1 28 18,200

Estimated Total Annual Burden 

Hours: 18,200. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Office. All requests 

should be identified by the title of the 

information collection. E-mail address: 

rsargis@acf.hhs.gov.

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Washington, DC, 

Attn: Desk Officer for ACF, E-mail: 

katherine_t._astrich@omb.eop.gov.

Dated: January 29, 2004. 

Robert Sargis, 

Reports Clearance, Officer.

[FR Doc. 04–2324 Filed 2–4–04; 8:45 am] 

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Grants Application Data 

Summary Administration for Native 

Americans Environmental Application 

Information. 

OMB No.: New collection. 

Description: Grants Application Data 

Summary (GADS) information is 

collected as part of a grant application. 

The GADS provides information used to 

prepare the legislatively mandated 

annual report to Congress on the status 

of American Indian and Native Alaskan 

communities. 

This information collected from 

applicants will allow the 

Administration for Native Americans to 

more accurately report to the 

Administration for Children and 

Families and to Congress on the status 

of American Indians and Native 

Alaskans. This information collection is 

conducted in accordance with 42 USC 

2991b–2(4). 

Respondents: Tribal governments, 

native non-profits, tribal colleges & 

universities. 

Annual Burden Estimates:

Instrument Number of

respondents 

Number of responses per 

respondent 

Average burden hours per 

response 

Total burden 

hours 

Environmental GADS Form ............................................................................. 650 1 28 18,200

Estimated Total Annual Burden 

Hours: 18,200. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. E-mail 

address: rsargis@acf.hhs.gov. All 

requests should be identified by the title 

of the information collection. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, 725 17th Street, NW., 

Washington, DC 20503, Attn: Desk