Federal Register / Vol. 63, No. 105 /Tuesday, June 2, 1998 / Notices 30005

and grantees, as a condition for a funding

award, to submit review protocols or criteria

that FDA can use in performing premarket

reviews of breakthrough products used in the

prevention, diagnosis and treatment of oral,

dental and cranio-facial diseases and

conditions. [S]

• Investigation into methods by which

NIDR and FDA can jointly and individually

promote the availability and use of FDA’s

adverse incident reporting systems (e.g.,

MedWatch) among oral health professionals

and other health and dental product user

groups. [S]

• Enlistment of NIDR technical, statistical

and clinical experts to assist FDA in the

design and content development of guidance

documents that FDA product reviewers can

use to assess product safety and

effectiveness. [L]

D. Fellowship Sponsorship

• Investigation into the merits and legal

aspects of establishing non-Federal

fellowships in which interested parties from

the private sector would subsidize

individuals with an interest in FDA

regulatory processes for one-year residency

periods. Under such an arrangement, NIDR

could serve as fiduciary in order to prevent

appearances of conflict-of-interest.

Fellowship assignments would entail

generalized exposure to and experience with

FDA regulatory procedures so as to also

avoid access to protected, product-specific

information that could be used for

competitive advantage. Fellows would also

be subjected to the controls, rights, privileges

and restrictions to which all other FDArecruited special government employees are

subjected. [L]

E. Policy Development

• Continuation of current interchanges and

expert consultations on selected policy issues

that engender wide-scale interest among

consumers and/or oral health professionals,

involve products or therapies that pose a

known or potential health risk to the general

public, relate to research and regulatory

processes affecting the pace of technology

transfer, etc. This activity should extend to

other matters of major import such as the

Surgeon General’s report on oral health

which NIDR has been charged to produce

and to which FDA can substantively

contribute. [I]

F. Research

• Continuation of ongoing research

collaborations, such as those between CBER

and NIDR’s Division of Intramural Research.

• Coordination of NIDR’s biological and

clinical resources and the CDRH’s

engineering and life sciences expertise to

address a number of diverse issues relating

to cleaning, infection and sensitivity

reactions to new biomaterials. [S]

• Establishment of one or more patient

registries for purposes of monitoring adverse

incidents linked to particular dental products

in addition to product-specific performance

trends. Such an activity could be jointly

undertaken by FDA and NIDR, as well as in

conjunction with involvement by other

organizations such as USP and various dental

professional and product user organizations.

[L]

• Initiation of collaborative research aimed

at developing fundamental data and methods

needed to assess long-term performance of

dental devices and systems. Such research

could include the joint development of

physical, animal and computer-based models

to adequately evaluate long-term clinical

performance of marketed and evolving dental

devices (e.g., osseous integration of dental

implants, fatigue performance of ceramic

porcelains, etc.). [L]

G. Advisory Committee & Study Section

Review/Appointments

• Provision of ad hoc or liaison status to

FDA officials on the NIDR National Advisory

Dental Research Council (including access to

closed sessions of the Council on a case-bycase, need-to-know basis), in addition to DRG

and other study sections/review groups for

the purpose of assisting NIDR in its review

of extramural research submissions. [S]

• Expansion of current NIDR participation

as consultants and/or Federal liaisons on

dental-related advisory committees and

panels managed by FDA (including access to

closed sessions on a case-by-case, need-toknow basis) for the purpose of augmenting

the scientific and clinical expertise that is

brought to bear on product applications and

proposed policies on which outside advice is

sought by the agency. [S]

• Formal solicitation of advice by each

party from the other on candidate

nominations for appointment to NIDR and

FDA review and advisory bodies. [S]

[FR Doc. 98–14462 Filed 6–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Proposed Collections; Comment

Request: National Institutes of Health

Construction Grants

SUMMARY: In compliance with the

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

the Paperwork Reduction Act of 1995,

for opportunity for public comment on

proposed data collection projects, the

Office of the Director (OD), the National

Institutes of Health (NIH), will publish

periodic summaries of proposed

projects to be submitted to the Office of

Management and Budget (OMB) for

review and approval.

PROPOSED COLLECTION: Title: National

Institutes of Health Construction Grants

(42 CFR Part 52b). Type of Information

Collection Request: Extension of OMB

No. 0925–0424, expiration date 09/30/

98. Need and Use of Information

Collection: This is a request for OMB

approval for the information collection

and recordkeeping requirements

contained in the final rule 42 CFR Part

52b. The purpose of the regulations is to

govern the awarding and administration

of grants awarded by NIH and its

components for construction of new

buildings and the alteration, renovation,

remodeling, improvement, expansion,

and repair of existing buildings,

including the provision of equipment

necessary to make the building (or

applicable part of the building) suitable

for the purpose for which it was

constructed. In terms of reporting

requirements:

Section 52b.9(b) of the proposed

regulations requires the transferor of a

facility which is sold or transferred, or

the owner of a facility, the use of which

has changed, to provide written notice

of the sale, transfer or change within 30

days. Section 52b.10(f) requires a

grantee to submit an approved copy of

the construction schedule prior to the

start of construction. Section 52b.10(g)

requires a grantee to provide daily

construction logs and monthly status

reports upon request at the job site.

Section 52b.11(b) requires applicants for

a project involving the acquisition of

existing facilities to provide the

estimated costs of the project, cost of the

acquisition of existing facilities, and

cost of remodeling, renovating, or

altering facilities to serve the purposes

for which they are acquired.

In terms of recordkeeping

requirements: Section 52b.10(g) requires

grantees to maintain daily construction

logs and monthly status reports at the

job site. Frequency of Response: On

occasion. Affected Public: Non-profit

organizations and Federal agencies.

Type of Respondents: Grantees. The

estimated respondent burden is as

follows:

Estimated annual reporting and recordkeeping burden

Annual

number of

respondents

Annual frequencyAverage burden perAnnual burden hours

Reporting:

§ 52b.9(b) ............................................................................................................... 1 1 .50 .50
30006 Federal Register / Vol. 63, No. 105 /Tuesday, June 2, 1998 / Notices

Estimated annual reporting and recordkeeping burden

Annual

number of

respondents

Annual frequencyAverage burden perAnnual burden hours

§ 52b.10(f) .............................................................................................................. 15 1 1 15

§ 52b.10(g) ............................................................................................................. 30 12 1 360

§ 52b.11(b) ............................................................................................................. 100 1 1 100

Recordkeeping:

§ 52b.10(g) ............................................................................................................. 30 260 1 7,800

Total ................................................................................................................... 176 .................... ...................... 8,275.50

The annualized cost to the public,

based on an average of 30 active grants

in the construction phase, is estimated

at: $273,000.

REQUEST FOR COMMENTS: Written

comments and/or suggestions from the

public and affected agencies should

address one or more of the following

points: (1) Evaluate whether the

proposed collection of information and

recordkeeping are necessary for the

proper performance of the function of

the agency, including whether the

information will have practical utility;

(2) Evaluate the accuracy of the agency’s

estimate of the burden of the proposed

collection of information and

recordkeeping, including the validity of

the methodology and assumptions used;

(3) Enhance the quality, utility, and

clarity of the information to be collected

and the recordkeeping information to be

maintained; and (4) Minimize the

burden of the collection of information

on those who are to respond, including

the use of appropriate automated,

electronic, mechanical, or other

technological collection and

recordkeeping techniques or other forms

of information technology.

FOR FURTHER INFORMATION CONTACT:

To request more information contact

Jerry Moore, NIH Regulations Officer,

Office of Management Assessment,

National Institutes of Health, 6011

Executive Boulevard, Room 601, MSC

7669, Rockville, MD 20852, or call 301–

496–4607 (this is not a toll-free

number), or E-mail your request to

<moorej@OD.NIH.gov.>

Comments Due Date: Comments

regarding this information collection

and recordkeeping are best assured to

having their full effect if received on or

before August 3, 1998.

Dated: May 27, 1998.

Jerry Moore,

Regulations Officer, National Institutes of

Health.

[FR Doc. 98–14498 Filed 6–1–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing: DNA

Vaccines for Chlamydia Trachomatis

AGENCY: National Institutes of Health,

Public Health Service, HHS.

ACTION: Notice.

SUMMARY: The inventions listed below

are owned by agencies of the U.S.

Government and are available for

licensing in the U.S. in accordance with

35 U.S.C. 207 to achieve expeditious

commercialization of results of

federally-funded research and

development. Foreign patent

applications are filed on selected

inventions to extend market coverage

for companies and may also be available

for licensing.

ADDRESSES: Licensing information and

copies of the U.S. patent applications

and issued patent listed below may be

obtained by contacting Robert Benson,

Ph.D., Technology Licensing Specialist,

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804; telephone: (301)

496–7056 ext. 267; fax: (301) 402–0220;

e-mail: rb20m@nih.gov. A signed

Confidential Disclosure Agreement will

be required to receive copies of the

patent applications.

Nucleotide, Deduced Amino Acid

Sequence, Isolation and Purification of

Heat-Shock Chlamydial Proteins

RB Morrison, HD Caldwell (NIAID)

Serial No. 07/531,317 Filed 31 May 90

(U.S. Patent 5,071,962 Issued 10 Dec.

91); Serial No. 07/841,323 Filed 25 Feb.

92 (Divisional of 07/531,317); Serial No.

09/071,506 Filed 01 May 98 (Divisional

of 07/841,323)

This invention concerns the discovery

of a novel gene that encodes the HSP60

protein from Chlamydia trachomatis,

referred to as HypB in the application.

This immunodominant protein is a

major target for Chlamydia trachomatis

vaccine development and diagnostics.

This gene and protein, or fragments

thereof, are useful in the development of

both recombinant protein and DNA

based vaccines. The recombinant

protein or DNA sequence also have

potential for the development of

diagnostic tests for C. trachomatis. The

three patent properties claim different

aspects of the invention. The issued

patent claims monoclonal antibodies

reactive against C. trachomatis HSP60

protein. Serial No. 07/841,323 claims

the HSP60 protein and its use as a

vaccine. Serial No. 09/071,506 claims

DNA sequences, and protein fragments

thereof, encoding HSP60. This DNA

sequence would be useful in a DNA

vaccine, alone or with the MOMP DNA

sequences claimed in Serial No. 07/

853,359. No foreign patent rights exist.

Nucleotide and Amino Acid Sequences

of the Four Variable Domains of the

Major Outer Membrane Proteins of

Chlamydia Trachomatis

H Caldwell et al. (NIAID)

Serial No. 07/853,359 Filed 16 Mar. 92

(With Priority to 17 Mar. 89)

Chlamydia trachomatis is the leading

sexually transmitted infectious agent in

the United States, causing about 10

million new cases per year. It is a major

cause of involuntary infertility in

women. This invention claims the DNA

sequences, and their encoded amino

acid sequences, of the four variable

domains from the major outer

membrane protein (MOMP) of

Chlamydia trachomatis, from the

serovars Ba, D, E, F, G, H, I, J, K, and

L3. Serovars D, E, F, G, H, I, J, and K

are the most common serovars

associated with Chlamydia trachomatis

caused sexually transmitted diseases.

The claimed variable domains of MOMP

contain the major antigen targets of

protective immunity including

neutralizing antibodies capable of

preventing chlamydial infection. Thus,

these sequences are useful for the

development of recombinant protein,

peptide, and DNA based vaccines