Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Notices 17563 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Critical Path Programs (HF–

18), Office of the Commissioner, Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857. Send one 

self-addressed adhesive label to assist 

that office in processing your requests. 

Submit telephone requests to 800–835–

4709 or 301–827–1800. Submit written 

comments on the draft guidance to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

to http://www.fda.gov/dockets/ 

ecomments. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Terrie L. Crescenzi, Office of Critical 

Path Programs (HF–18), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–7864. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for clinical 

investigators, sponsors, and IRBs 

entitled ‘‘Guidance for Clinical 

Investigators, Sponsors, and IRBs; 

Adverse Event Reporting—Improving 

Human Subject Protection.’’ Under the 

regulations in 21 CFR part 50 

(Protection of Human Subjects), part 56 

(21 CFR part 56) (Institutional Review 

Boards), part 312 (21 CFR part 312) 

(Investigational New Drug Application), 

and part 812 (21 CFR part 812) 

(Investigational Device Exemptions), an 

IRB must review and approve a clinical 

study before the study is initiated. 

Additionally, after an IRB’s initial 

review and approval, an IRB must 

conduct continuing review of the study 

at intervals appropriate to the degree of 

risk presented by the study, at least 

annually. The primary purpose of both 

the initial review of a study and the 

periodic review of the conduct of the 

study is to assure the protection of the 

rights and welfare of human subjects. To 

assure the protection of the rights and 

welfare of human subjects during the 

conduct of a clinical study, an IRB must 

have information concerning 

unanticipated problems in the study 

and changes in the research activity. 

Such information may be important to 

the IRB’s review. This draft guidance 

discusses adverse event reporting to 

IRBs by sponsors, and investigators, and 

emphasizes the greater value of wellanalyzed adverse event data to an IRBs 

review. This draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the agency’s 

current thinking on adverse event 

reporting for the purpose of improving 

human subject protection. It does not 

create or confer any rights for or on any 

person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. The Paperwork Reduction Act of 

1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in part 56 have been 

approved under OMB Control No. 0910–

0130; the collections of information in 

part 312 have been approved under 

OMB Control No. 0910–0014; and the 

collections of information in part 812 

have been approved under OMB Control 

No. 0910–0078. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: April 2, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–6595 Filed 4–6–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0117] 

Draft Guidance for Industry on Orally 

Disintegrating Tablets; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Orally Disintegrating 

Tablets.’’ The draft guidance provides 

pharmaceutical manufacturers of new 

and generic drug products with an 

agency perspective on the definition of 

an orally disintegrating tablet (ODT) and 

also provides recommendations to 

applicants who would like to designate 

a proposed product as an ODT. 

DATES: Submit written or electronic 

comments on the draft guidance by June 

8, 2007. General comments on agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Frank O. Holcombe, Jr., Center for Drug 

Evaluation and Research (HFD–600), 

Food and Drug Administration, 7500 

Standish Pl., Rockville, MD 20855, 240–

276–9310. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Orally Disintegrating Tablets.’’ The 

draft guidance provides pharmaceutical 

manufacturers of new and generic drug 

products with an agency perspective on 

the definition of an ODT and also 

provides recommendations to 

applicants who would like to designate 

proposed products as ODTs. 


sroberts on PROD1PC70 with NOTICES
17564 Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Notices 

In an effort to develop drug products 

that are more convenient to use and to 

address potential issues of patient 

compliance for certain product 

indications and patient populations, 

pharmaceutical manufacturers have 

developed products that can be ingested 

simply by placing them on the tongue. 

The products are designed to 

disintegrate or dissolve rapidly on 

contact with saliva, thus eliminating the 

need for chewing the tablet, swallowing 

an intact tablet, or taking the tablet with 

water. This mode of administration was 

initially expected to be beneficial to 

pediatric and geriatric patients, to 

people with conditions related to 

impaired swallowing, and for treatment 

of patients when compliance may be 

difficult (e.g., for psychiatric disorders). 

As firms started developing additional 

products using different technology and 

formulations, many of these later 

products exhibited wide variation in 

product characteristics from the initial 

products. Because this shift in product 

characteristics can affect a product’s 

suitability for particular uses, the 

agency developed this guidance for 

industry. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on orally disintegrating tablets. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: March 30, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–6509 Filed 4–6–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Council on Graduate Medical 

Education; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Council on Graduate Medical 

Education (COGME). 

Dates and Times: April 30, 2007, 8:30 

a.m.– 5 p.m.; and May 1, 2007, 8:30 a.m.–

2:30 p.m. 

Place: Hilton Washington, DC/Rockville 

Executive Meeting Center, 1750 Rockville 

Pike, Rockville, Maryland 20852–1699. 

Status: The meeting will be open to the 

public. 

Agenda: The agenda for April 30 in the 

morning will include: Welcome and opening 

comments from the Chair and Executive 

Secretary of COGME and senior management 

staff of the Health Resources and Services 

Administration. 

On April 30, following the welcoming 

remarks from the COGME Chair, the 

Executive Secretary of COGME, and Agency 

senior management, there will be a review 

and discussion of the draft paper ‘‘Enhancing 

GME Flexibility,’’ by Barbara Chang, M.D., 

and other writing group members. After 

lunch there will be a review and discussion 

of the draft paper ‘‘New Paradigms for 

Physician Training for Improving Access to 

Healthcare’’ by Earl Reisdorff, M.D. and other 

writing group members. At 3 p.m. there will 

be a breakout of Council members into the 

two draft writing groups for further report 

revisions. 

On May 1 there will be reports to the 

Council and further discussion on writing 

group activities and reports. The Council will 

conclude with a discussion of the timeframe 

and next steps for producing the Reports. 

Agenda items are subject to change as 

priorities dictate. 

FOR FURTHER INFORMATION CONTACT: 

Jerald M. Katzoff, Executive Secretary, 

COGME, Division of Medicine and 

Dentistry, Bureau of Health Professions, 

Parklawn Building, Room 9A–27, 5600 

Fishers Lane, Rockville, Maryland 

20857, Telephone (301) 443–6785. 

Dated: April 2, 2007. 

Caroline Lewis, 

Acting Associate Administrator for 

Administration and Financial Management. 

[FR Doc. E7–6597 Filed 4–6–07; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Reimbursement of Travel and 

Subsistence Expenses Toward Living 

Organ Donation Proposed Eligibility 

Guidelines 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Request for Public Comment. 

SUMMARY: HRSA is soliciting comments 

on the proposed eligibility criteria for 

the Reimbursement of Travel and 

Subsistence Expenses toward Living 

Organ Donations Program. Eligibility 

criteria were proposed by the program 

grantee, the Regents of the University of 

Michigan, to HRSA. HRSA has 

determined that the proposed eligibility 

criteria constitute a proper 

interpretation of the authorizing 

statute’s requirements, including 

determinations as to which individuals 

would otherwise be unable to meet the 

eligible expenses authorized under this 

Program. HRSA is soliciting public 

comment on the criteria outlined in this 

notice. HRSA will consider the 

comments in light of the authorizing 

statute and seek feedback from the 

Regents of the University of Michigan 

concerning the comments. HRSA will 

then approve final criteria. The final 

program eligibility criteria will be 

posted on the Reimbursement of Travel 

and Subsistence Expenses for Living 

Organ Donation Web site, http:// 

www.livingdonorassistance.org. 

DATES: Written comments must be 

submitted to the office in the address 

section below by mail or e-mail on or 

before May 24, 2007. 

ADDRESSES: Please send all written 

comments to James F. Burdick, M.D., 

Director, Division of Transplantation, 

Healthcare Systems Bureau, Health 

Resources and Services Administration, 

Room 12C–06, Parklawn Building, 5600 

Fishers Lane, Rockville, Maryland 

20857; telephone (301) 443–7577; fax 

(301) 594–6095; or e-mail: 

jburdick@hrsa.gov. 

FOR FURTHER INFORMATION CONTACT: 

James F. Burdick, M.D., Director, 

Division of Transplantation, Healthcare 

Systems Bureau, Health Resources and 

Services Administration, Parklawn 

Building, Room 12C–06, 5600 Fishers 

Lane, Rockville, Maryland 20857; 

telephone (301) 443–7577; fax (301) 

594–6095; or e-mail: jburdick@hrsa.gov. 

SUPPLEMENTARY INFORMATION: Congress 

has provided specific authority under 


sroberts on PROD1PC70 with NOTICES