2556 Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Notices 

a submission describing a product 

intended to repair or replace knee 

cartilage. The guidance does not apply 

to prostheses such as unicondylar or 

total knee implants, or meniscus 

replacement products. The guidance 

supplements recommendations 

regarding IDE and IND submissions 

contained in other FDA publications. 

The guidance announced in this notice 

finalizes the draft guidance of the same 

title dated July 2007. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448; or the 

Division of Small Manufacturers, 

International, and Consumer Assistance, 

Center for Devices and Radiological 

Health (CDRH), Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 4613, Silver Spring, 

MD 20993. Send one self-addressed 

adhesive label to assist the office in 

processing your requests. The guidance 

may also be obtained by mail by calling 

CBER at 1–(800) 835–4709 or (301) 827– 

1800; or by calling CDRH at 1–(800) 

638–2041 or by faxing a request to 

CDRH at (301) 847–8149. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: Lori 

Jo Churchyard, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, (301) 827–6210; or 

Elizabeth L. Frank, Center for Devices 

and Radiological Health, 10903 New 

Hampshire Ave., Bldg. 66, rm. 1407, 

Silver Spring, MD 20993, (301) 796– 

5650. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Guidance for 

Industry: Preparation of IDEs and INDs 

for Products Intended to Repair or 

Replace Knee Cartilage’’ dated 

December 2011. The guidance 

document provides sponsors of an IDE 

or an IND recommendations about 

certain information that should be 

included in a submission describing a 

product intended to repair or replace 

knee cartilage. The guidance does not 

apply to prostheses such as unicondylar 

or total knee implants, or meniscus 

replacement products. Human cells, 

tissues, and cellular and tissue-based 

products (HCT/P’s) regulated solely 

under section 361 of the Public Health 

Service Act (42 U.S.C. 264) and 21 CFR 

part 1271 are beyond the scope of this 

guidance. A product intended to repair 

or replace knee cartilage may include a 

biologic, device, or combination product 

(comprised of two or more different 

types of regulated constituents) whose 

components would individually be 

regulated by CBER and CDRH. The 

guidance addresses issues that may arise 

in the development of articular cartilage 

repair or replacement products. The 

guidance supplements other FDA 

publications on IDEs and INDs that may 

be relevant to development of these 

products. 

In the Federal Register of July 9, 2007 

(72 FR 37245), FDA announced the 

availability of the draft guidance of the 

same title dated July 2007. FDA 

received numerous comments on the 

draft guidance, and those comments 

were considered as the guidance was 

finalized. In response to comments, 

changes incorporated in the guidance 

included adding new sections and 

clinical study schedules, elaborating on 

nonclinical data considerations, and 

updating the references. In addition, 

organizational and editorial changes 

were made to improve clarity. Some 

terminology was changed to harmonize 

terminology within the Agency and 

does not change the intent of the 

guidance. The guidance also reflects 

input received from the public and the 

Cellular, Tissue, and Gene Therapy 

Advisory Committee meeting held on 

May 15, 2009. The guidance announced 

in this notice finalizes the draft 

guidance dated July 2007. 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents 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 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

The 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 part 312 have been approved 

under OMB control number 0910–0014; 

and the collections of information in 21 

CFR part 812 have been approved under 

OMB control number 0910–0078. 

III. 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. 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either: 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/

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

MedicalDevices/DeviceRegulationand

Guidance/GuidanceDocuments/

default.htm, or http:// 

www.regulations.gov. 

Dated: January 11, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–828 Filed 1–17–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Ethical and Regulatory Challenges in 

the Development of Pediatric Medical 

Countermeasures; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA), Office of Pediatric Therapeutics, 

is announcing a public workshop 

entitled ‘‘Ethical and Regulatory 

Challenges in the Development of 

Pediatric Medical Countermeasures.’’ 

There is a critical need for pediatric 

research on medical countermeasures to 

ensure that these products are safe and 

effective in the pediatric population. 

The challenges to developing and 

evaluating drugs, biologics, and devices 

for children in the medical 

countermeasure context are complex 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 11 / Wednesday, January 18, 2012 / Notices 2557 

and need to be better understood by 

ethicists, researchers, policymakers, and 

the general public. The purpose of the 

public workshop is to provide a forum 

for careful consideration of scientific, 

ethical, and regulatory issues 

confronting FDA and other stakeholders 

in the area of medical countermeasures 

and public health preparedness. 

Date and Time: The public workshop 

will be held on February 15, 2012, from 

8:30 a.m. to 5 p.m. and February 16, 

2012, from 8:30 a.m. to 3 p.m. 

Location: The public workshop will 

be held at the Rockville Hilton Hotel, 

1750 Rockville Pike, Rockville, MD 

20852. 

Contact Person: Cindy de Sales, (240) 

316–3207, FAX: (240) 316–3201, email: 

cindy@tepgevents.com. 

Registration: Please use the following 

Web site to register online: http:// 

www.contractmeetings.com. 

Alternatively, you can email or fax your 

registration information (including 

name, title, firm name, address, 

telephone and fax numbers) to the 

contact person by February 1, 2012. 

There is no registration fee for the 

public workshop. Early registration is 

recommended because seating is 

limited. Registration on the day of the 

public workshop will be provided on a 

space available basis beginning at 8 a.m. 

If you need special accommodations 

due to a disability, please contact Cindy 

de Sales (see Contact Person) at least 

7 days in advance. 

SUPPLEMENTARY INFORMATION: The 

workshop will include plenaries and 

breakout sessions on the ethical and 

regulatory challenges in the 

development of medical 

countermeasures for the pediatric 

population. Topics of the breakout 

sessions will include: (1) Institutional 

Review Board preparedness to review 

study protocols relevant to pediatric 

medical countermeasures; (2) potential 

scientific and ethical justifications for 

conducting pre-event pediatric medical 

countermeasures research; (3) leveraging 

new technologies to develop pediatric 

medical countermeasures; and (4) risk 

communication related to pediatric 

treatment and research during public 

health emergencies. The workshop also 

will include discussion of a number of 

case studies to facilitate discussion of 

the challenges of pediatric medical 

countermeasure development and 

deployment. 

Transcripts: Transcripts of the public 

workshop may be requested in writing 

from the Division of Freedom of 

Information (ELEM–1029), Food and 

Drug Administration, 12420 Parklawn 

Dr., Element Bldg., Rockville, MD 

20857, approximately 15 working days 

after the public workshop at the cost of 

10 cents per page. A transcript of the 

public workshop will be available on 

the Internet at http:// 

www.regulations.gov, Docket No. FDA– 

2011–N–0002. Transcripts may also be 

viewed at the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Dated: January 12, 2012. 

David Dorsey, 

Acting Associate Commissioner for Policy and 

Planning. 

[FR Doc. 2012–846 Filed 1–17–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the meeting of the 

National Cancer Advisory Board. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

A portion of the meeting 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 

Advisory Board Ad hoc Subcommittee on 

Global Cancer Research. 

Open: February 27, 2012, 6:30 p.m. to 

8 p.m. 

Agenda: Discussion on Global Cancer. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, Bethesda, Maryland 

20814. 

Contact Person: Dr. Ted Trimble, Executive 

Secretary, NCAB Ad hoc Subcommittee on 

Global Cancer Research, National Cancer 

Institute, National Institutes of Health, 6130 

Executive Boulevard, EPN/7025, Rockville, 

MD 20892–8345, (301) 496–2522, 

trimblet@mail.nih.gov. 

Name of Committee: National Cancer 

Advisory Board. 

Open: February 28, 2012, 9 a.m. to 

3:30 p.m. 

Agenda: Program reports and 

presentations; business of the Board. 

Place: National Institutes of Health, 9000 

Rockville Pike, Building 31, C Wing, 6th 

Floor, Conference Room 10, Bethesda, MD 

20892. 

Closed: February 28, 2012, 3:30 p.m. to 5 

p.m. 

Agenda: Review of grant applications. 

Place: National Institutes of Health, 9000 

Rockville Pike, Building 31, C Wing, 6th 

Floor, Conference Room 10, Bethesda, MD 

20892. 

Contact Person: Dr. Paulette S. Gray, 

Executive Secretary, National Cancer 

Institute, National Institutes of Health, 6116 

Executive Boulevard, 8th Floor, Room 8001, 

Bethesda, MD 20892–8327, (301) 496–5147. 

Name of Committee: National Cancer 

Advisory Board. 

Open: February 29, 2012, 9 a.m. to 12 p.m. 

Agenda: Program reports and 

presentations; business of the Board. 

Place: National Institutes of Health, 9000 

Rockville Pike, Building 31, C Wing, 6th 

Floor, Conference Room 10, Bethesda, MD 

20892. 

Contact Person: Dr. Paulette S. Gray, 

Executive Secretary, National Cancer 

Institute, National Institutes of Health, 6116 

Executive Boulevard, 8th Floor, Room 8001, 

Bethesda, MD 20892–8327, (301) 496–5147. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institute’s/Center’s home page: 

deainfo.nci.nih.gov/advisory/ncab.htm, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(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) 


tkelley on DSK3SPTVN1PROD with NOTICES