60130 Federal Register / Vol. 75, No. 188 / Wednesday, September 29, 2010 / Notices 

Reporting Requirements for 

Bioavailability and Bioequivalence 

Studies in Humans,’’ published 

elsewhere in this issue of the Federal 

Register. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by December 28, 

2010. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002; or the 

Office of Communication, Outreach, and 

Development (HFM–40), Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

on the draft guidance to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Janet Norden, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6324, 

Silver Spring, MD 20993–0002, 301– 

796–2500; or Laura Rich, Center for 

Biologics Evaluation and Research, 

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a draft guidance for industry and 

investigators entitled ‘‘Safety Reporting 

Requirements for INDs and BA/BE 

Studies.’’ This draft guidance is 

intended to help sponsors and 

investigators comply with the new 

requirements for investigational new 

drug applications (IND) safety reporting 

and safety reporting for bioavailability 

(BA) and bioequivalence (BE) studies. 

In the Federal Register of March 14, 

2003 (68 FR 12406), FDA published a 

proposed rule to revise its regulations 

governing pre- and postmarket safety 

reporting for human drug and biological 

products. To make rulemaking more 

manageable, the Agency decided to 

issue revisions to the pre- and 

postmarket safety reporting regulations 

in two separate rulemakings. The final 

rule, entitled ‘‘Investigational New Drug 

Safety Reporting Requirements for 

Human Drug and Biological Products 

and Safety Reporting Requirements for 

Bioavailability and Bioequivalence 

Studies in Humans,’’ published 

elsewhere in this issue of the Federal 

Register, revises the premarket 

regulations. The revisions in the final 

rule will improve the utility and quality 

of safety reports, expedite and 

strengthen FDA’s ability to review 

critical safety information, improve 

safety monitoring of human drug and 

biological products, better protect 

human subjects enrolled in clinical 

trials, and harmonize safety reporting 

internationally. The new requirements 

revise the definitions used for IND 

safety reporting, make clear when to 

submit IND safety reports, and subject 

BA and BE studies to safety reporting 

requirements. 

The draft guidance was developed to 

accompany the publication of the final 

rule. The draft guidance provides 

examples and explanations of the 

definitions used for IND safety 

reporting, makes recommendations for 

determining when and how to submit a 

safety report, and provides advice on 

other safety reporting issues that have 

generated questions from sponsors and 

investigators. 

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 the Agency’s current thinking 

on safety reporting requirements for 

INDs and BA/BE studies. 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) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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 contains 

information collection provisions that 

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 collection(s) 

of information in the draft guidance are 

estimated in section ‘‘VII. Paperwork 

Reduction Act of 1995’’ of the final rule 

entitled, ‘‘Investigational New Drug 

Safety Reporting Requirements for 

Human Drug and Biological Products 

and Safety Reporting Requirements for 

Bioavailability and Bioequivalence 

Studies in Humans’’ published 

elsewhere in this issue of the Federal 

Register. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: September 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–24295 Filed 9–28–10; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; Basic and 

Translational Oncology P01. 

Date: September 30–October 1, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda North Marriott Hotel & 

Conference Center, 5701 Marinelli Road, 

Bethesda, MD 20852. 

Contact Person: Shakeel Ahmad, PhD, 

Scientific Review Officer, Research Programs 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 75, No. 188 / Wednesday, September 29, 2010 / Notices 60131 

Review Branch, Division of Extramural 

Activities, National Cancer Institute, NIH, 

6116 Executive Boulevard, Room 8137, 

Bethesda, MD 20892–8328, (301) 594–0114, 

ahmads@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to scheduling 

conflicts. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; Cancer 

Prevention Research Small Grant Program 

(R03). 

Date: October 28–29, 2010. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Renaissance Washington, DC 

DuPont Circle Hotel, 1143 New Hampshire 

Avenue, NW., Washington, DC 20037. 

Contact Person: Irina Gordienko, PhD, 

Scientific Review Officer, Scientific Review 

and Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, NIH, 

6116 Executive Blvd., Rm. 7073, Bethesda, 

MD 20892, 301–594–1566, 

gordienkoiv@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: September 22, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–24414 Filed 9–28–10; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of an Interagency Autism 

Coordinating Committee (IACC) 

meeting. 

The purpose of the IACC meeting is 

to listen to presentations on various 

aspects of autism spectrum disorder 

research and services and to discuss 

plans for the annual update of the IACC 

Strategic Plan for Autism Spectrum 

Disorders Research. The meeting will be 

open to the public and will be 

accessible by webcast and conference 

call. 

Name of Committee: Interagency Autism 

Coordinating Committee (IACC). 

Type of meeting: Open meeting. 

Date: October 22, 2010. 

Time: 10 a.m. to 5 p.m.* Eastern Time *— 

Approximate end time. 

Agenda: Invited speakers will give 

presentations on various aspects of autism 

spectrum disorder research and services and 

the IACC will discuss plans for the annual 

update of the IACC Strategic Plan for Autism 

Spectrum Disorder Research. 

Place: The National Institutes of Health, 

Main Campus, William H. Natcher 

Conference Center, 45 Center Drive, 

Conference Rooms E1/E2, Bethesda, MD 

20892. 

Webcast Live: http://videocast.nih.gov/. 

Conference Call Access: Dial: 1–888–577– 

8995; Access code: 1991506. 

Cost: The meeting is free and open to the 

public. 

Registration: http:// 

www.acclaroresearch.com/oarc/10-22- 

10_IACC. Pre-registration is recommended to 

expedite check-in. Seating in the meeting 

room is limited to room capacity and on a 

first come, first served basis. 

Deadlines: Notification of intent to present 

oral comments: October 14th by 5 p.m. ET. 

Submission of written/electronic statement 

for oral comments: October 15th by 5 p.m. 

ET. 

Submission of written comments: October 

18th by 5 p.m. ET. 

Access: Metro accessible—Medical Center 

Metro (Red Line). 

Contact Person: Ms. Lina Perez, Office of 

Autism Research Coordination, National 

Institute of Mental Health, NIH, 6001 

Executive Boulevard, Room 8200, Bethesda, 

MD 20892–9669. Phone: 301–443–6040. Email: IACCPublicInquiries@mail.nih.gov. 

Please Note: Any member of the public 

interested in presenting oral comments to the 

Committee must notify the Contact Person 

listed on this notice by 5 p.m. ET on 

Thursday, October 14, 2010 with their 

request to present oral comments at the 

meeting. Interested individuals and 

representatives of organizations must submit 

a written/electronic copy of the oral 

statement/comments including a brief 

description of the organization represented 

by 5 p.m. ET on Friday, October 15, 2010. 

Statements submitted will become a part of 

the public record. Only one representative of 

an organization will be allowed to present 

oral comments and presentations will be 

limited to three to five minutes per speaker, 

depending on number of speakers to be 

accommodated within the allotted time. 

Speakers will be assigned a time to speak in 

the order of the date and time when their 

request to speak is received, along with the 

required submission of the written/electronic 

statement by the specified deadline. 

In addition, any interested person may 

submit written comments to the IACC prior 

to the meeting by sending the comments to 

the Contact Person listed on this notice by 5 

p.m. ET, Monday, October 18, 2010. The 

comments should include the name and 

when applicable, the business or professional 

affiliation of the interested person. All 

written comments received by the deadlines 

for both oral and written public comments 

will be provided to the IACC for their 

consideration and will become part of the 

public record. 

The meeting will be open to the public 

through a conference call phone number and 

webcast live on the Internet. Members of the 

public who participate using the conference 

call phone number will be able to listen to 

the meeting but will not be heard. If you 

experience any technical problems with the 

webcast live or conference call, please e-mail 

IACCTechSupport@acclaroresearch.com. 

Individuals who participate in person or by 

using these electronic services and who need 

special assistance, such as captioning of the 

conference call or other reasonable 

accommodations, should submit a request to 

the Contact Person listed on this notice at 

least 7 days prior to the meeting. 

To access the webcast live on the Internet 

the following computer capabilities are 

required: (A) Internet Explorer 5.0 or later, 

Netscape Navigator 6.0 or later or Mozilla 

Firefox 1.0 or later; (B) Windows® 2000, XP 

Home, XP Pro, 2003 Server or Vista; (C) 

Stable 56k, cable modem, ISDN, DSL or 

better Internet connection; (D) Minimum of 

Pentium 400 with 256 MB of RAM 

(Recommended); (E) Java Virtual Machine 

enabled (Recommended). 

NIH has instituted stringent security 

procedures for entrance onto the NIH 

campus. All visitors must enter through the 

NIH Gateway Center. This center combines 

visitor parking, non-commercial vehicle 

inspection and visitor ID processing, all in 

one location. The NIH will process all 

visitors in vehicles or as pedestrians. You 

will be asked to submit to a vehicle or 

personal inspection and will be asked to state 

the purpose of your visit. Visitors over 15 

years of age must provide a form of 

government-issued ID such as a driver’s 

license or passport. All visitors should be 

prepared to have their personal belongings 

inspected and to go through metal detection 

inspection. 

When driving to NIH, plan some extra time 

to get through the security checkpoints. Be 

aware that visitor parking lots on the NIH 

campus can fill up quickly. The NIH campus 

is also accessible via the metro Red Line, 

Medical Center Station. The William H. 

Natcher Conference Center is a 5-minute 

walk from the Medical Center Metro Station. 

Additional NIH campus visitor information 

is available at: http://www.nih.gov/about/ 

visitor/index.htm. 

As a part of security procedures, attendees 

should be prepared to present a photo ID at 

the meeting registration desk during the 

check-in process. Pre-registration is 

recommended. Seating will be limited to the 

room capacity and seats will be on a first 

come, first served basis, with expedited 

check-in for those who are pre-registered. 

Meeting schedule subject to change. 

Information about the IACC is available on 

the website: http://www.iacc.hhs.gov. 

Dated: September 22, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–24403 Filed 9–28–10; 8:45 am] 

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