17562 Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Notices 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Dosage and 

Administration Section of Labeling for 

Human Prescription Drug and Biological 

Products—Content and Format.’’ This 

draft guidance is one of a series of 

guidance documents intended to assist 

applicants in drafting prescription drug 

labeling in which prescribing 

information is clear and accessible and 

complying with the new requirements 

in the final rule on the content and 

format of labeling for prescription drug 

and biological products (71 FR 3922, 

January 24, 2006). This draft guidance is 

intended to help applicants select 

information for inclusion in the ‘‘Dosage 

and Administration’’ section of labeling 

and to help them organize that 

information. 

DATES: Submit written or electronic 

comments on the draft guidance by July 

9, 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single copies of the draft guidance to the 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; or the Office of 

Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448. 

The draft guidance may also be obtained 

by mail by calling CBER at 1–800–835–

4709 or 301–827–1800. Send two selfaddressed adhesive labels to assist the 

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: 

Joseph P. Griffin, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 4204, 

Silver Spring, MD 20993–0002, 

301–796–1077; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448, 301–

827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Dosage and Administration Section of 

Labeling for Human Prescription Drug 

and Biological Products—Content and 

Format.’’ The draft guidance provides 

recommendations on how to select 

information for inclusion in the ‘‘Dosage 

and Administration’’ section of labeling 

and how to organize information within 

the section. This draft guidance is one 

of a series guidances FDA is developing, 

or has developed, to assist applicants 

and reviewers with the format and 

content of certain sections of the 

labeling for prescription drugs. In the 

Federal Register of January 24, 2006 (71 

FR 3998 and 3999), FDA issued final 

guidances on the format and content of 

the ‘‘Adverse Reactions’’ and ‘‘Clinical 

Studies’’ sections of labeling and draft 

guidances on implementing the new 

labeling requirements for prescription 

drugs and the format and content of the 

‘‘Warnings and Precautions,’’

‘‘Contraindications,’’ and ‘‘Boxed 

Warning’’ sections of labeling. The new 

labeling requirements (71 FR 3922) and 

these guidances are intended to make 

information in prescription drug 

labeling easier for health care 

practitioners to access, read, and use. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent FDA’s current thinking on this 

topic. 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 requirement 

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 the draft guidance. 

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. 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 21 CFR 201.57 have 

been approved under OMB control 

number 0910–0572. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at http:// 

www.fda.gov/ohrms/dockets/ 

default.htm, http://www.fda.gov/cder/ 

guidance/index.htm, or http:// 

www.fda.gov/cber/guidelines.htm. 

Dated: March 30, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–6508 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–0106] 

Draft Guidance for Clinical 

Investigators, Sponsors, and 

Investigational Review Boards on 

Adverse Event Reporting—Improving 

Human Subject Protection; 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 ‘‘Guidance for Clinical 

Investigators, Sponsors, and IRBs; 

Adverse Event Reporting—Improving 

Human Subject Protection.’’ This 

guidance is intended to assist the 

research community in interpreting 

requirements for submitting reports of 

unanticipated problems, including 

certain adverse events reports, to the 

Institutional Review Board (IRB). FDA 

developed this draft guidance in 

response to concerns raised by the IRB 

community that increasingly large 

volumes of individual adverse event 

reports are inhibiting rather than 

enhancing IRBs’ ability to adequately 

protect human subjects. The guidance 

provides recommendations to IRBs, 

sponsors, and investigators on 

improving the usefulness of the adverse 

event information submitted to IRBs. 

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. 


sroberts on PROD1PC70 with NOTICES
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