Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Notices 15993 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Division of Drug Information (HFD– 

240), 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 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. The 

guidance may also be obtained by mail 

by calling CBER at 1–800–835–4709 or 

301–827–1800. Send two self-addressed 

adhesive labels to assist the office in 

processing your requests. Requests and 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. Submit 

written comments on the 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.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Robert H. 

King, Sr., Center for Drug 

Evaluation and Research (HFD– 

003), Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 4150, 

Silver Spring, MD 20993–0002, 

301–796–1242; or Christopher 

Joneckis, Center for Biologics 

Evaluation and Research (HFM–25), 

Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448, 301– 

827–0373. 

Regarding the ICH: Michelle Limoli, 

Office of International Programs 

(HFG–1), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827– 

4480. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In the Federal Register of August 5, 

2008 (73 FR 45467), FDA published a 

notice announcing the availability of a 

draft tripartite guidance entitled ‘‘Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

ICH Regions; Annex 4C: Microbiological 

Examination of Non-Sterile Products: 

Acceptance Criteria for Pharmaceutical 

Preparations and Substances for 

Pharmaceutical Use General Chapter.’’ 

The notice gave interested persons an 

opportunity to submit comments by 

October 6, 2008. 

After consideration of the comments 

received and revisions to the guidance, 

a final draft guidance entitled ‘‘Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

ICH Regions; Annex 4C: Microbiological 

Examination of Nonsterile Products: 

Acceptance Criteria for Pharmaceutical 

Preparations and Substances for 

Pharmaceutical Use General Chapter’’ 

was submitted to the ICH Steering 

Committee and endorsed by the three 

participating regulatory agencies in 

November 2008. 

The guidance provides the specific 

evaluation outcome from the ICH Q4B 

process for the Microbiological 

Examination of Nonsterile Products: 

Acceptance Criteria for Pharmaceutical 

Preparations and Substances for 

Pharmaceutical Use General Chapter 

harmonization proposal originating 

from the three-party PDG. This guidance 

is in the form of an annex to the core 

ICH Q4B guidance. When implemented, 

the annex will provide guidance for 

industry and regulators on the use of the 

specific pharmacopoeial texts evaluated 

by the ICH Q4B process. Following 

receipt of comments on the draft, no 

substantive changes were made to the 

annex. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’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. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the 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. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.regulations.gov, http:// 

www.fda.gov/cder/guidance/index.htm, 

or http://www.fda.gov/cber/ 

guidelines.htm. 

Dated: March 31, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–7905 Filed 4–7–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration. 

[Docket No. FDA–2009–N–0167] 

Propylthiouracyl (PTU)-Related Liver 

Toxicity; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 


rwilkins on PROD1PC63 with NOTICES
15994 Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Notices 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

1-day public workshop, cosponsored 

with the American Thyroid Association 

(ATA), entitled ‘‘Propylthiouracyl 

(PTU)-Related Liver Toxicity.’’ This 

public workshop is intended to provide 

a public forum for discussion of the 

clinical, scientific, and regulatory issues 

pertaining to PTU-induced hepatitis to 

seek constructive input from academia, 

regulatory scientists, and other 

interested parties on the topic of PTUinduced hepatitis. The input from this 

public workshop will help the ATA to 

develop guidelines for the management 

of hyperthyroidism and help inform 

FDA about necessary changes to 

prescription drug labeling for PTU. 

DATES: This public workshop will be 

held on Saturday, April 18, 2009, from 

8 a.m. to 3:30 p.m. However, depending 

on the level of public participation, the 

meeting may be extended or may end 

early. Written or electronic comments 

will be accepted after the workshop 

until June 19, 2009. 

ADDRESSES: The public workshop will 

be held at the Madison Hotel at 1177 

15th St., NW., Washington, DC 20005, 

202–862–1600. We are opening a docket 

to receive your written or electronic 

comments. Written or electronic 

comments must be submitted to the 

docket by June 19, 2009. 

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 

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

Comments should be identified with 

the docket number found in brackets in 

the heading of this document. 

Transcripts of the workshop will be 

available for review at the Division of 

Dockets Management and on the 

Internet at http://www.regulations.gov 

approximately 45 days after the 

workshop. 

FOR FURTHER INFORMATION CONTACT: Jeff 

O’Neill, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 6167, Silver Spring, 

MD 20903, 301–796–0777, FAX: 301– 

847–8753, e-mail: 

jeff.o’neill@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

PTU-related liver toxicity has been 

reported in the published literature, and 

while direct comparative studies to 

another approved anti-thyroid 

medication, methimazole, are lacking, 

case series and postmarketing adverse 

event reports suggest a greater risk 

associated with PTU than methimazole. 

From prescription usage data, it appears 

that PTU is used less frequently than 

methimazole with perhaps a preferential 

use during pregnancy because of 

concerns about a rare congenital defect 

described in case reports of 

methimazole use. However, some data 

question whether an advantage of PTU 

use over methimazole exists, even 

during pregnancy. 

FDA and ATA are sponsoring this 

open public discussion involving 

academia, regulatory scientists, and 

other interested parties on the topic of 

PTU-induced hepatitis, because it is 

important to the health of patients with 

thyroid disease that the applicable 

scientific, clinical, and regulatory issues 

are raised and fully elucidated, and, to 

the greatest extent possible, consensus 

is reached. 

The ATA serves clinicians, scientists, 

and patients to facilitate open 

interchange and dissemination of 

scientific knowledge. The workshop is 

intended to provide a forum for 

discussion of the clinical, scientific, and 

regulatory issues pertaining to PTUinduced hepatitis. 

II. Registration 

There is no fee to attend the 

workshop, and attendees do not need to 

register. Seating will be on a first-come, 

first-served basis. If you need special 

accommodations because of disability, 

please contact Jeff O’Neill (see FOR

FURTHER INFORMATION CONTACT) at least 7 

days before the workshop. 

Dated: April 2, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–7993 Filed 4–7–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of Meeting; Advisory Council on 

Blood Stem Cell Transplantation 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Notice of Meeting of the 

Advisory Council on Blood Stem Cell 

Transplantation. 

SUMMARY: Pursuant to Public Law 92– 

463, the Federal Advisory Committee 

Act, as amended (5 U.S.C. Appendix 2), 

notice is hereby given of the fourth 

meeting of the Advisory Council on 

Blood Stem Cell Transplantation 

(ACBSCT), Department of Health and 

Human Services (HHS). The meeting 

will be held from approximately 8:30 

a.m. to 5 p.m. on May 12, 2009, at the 

Bethesda North Marriott Hotel and 

Convention Center, 5701 Marinelli 

Road, Bethesda, MD 20852. The meeting 

will be open to the public; however, 

seating is limited and pre-registration is 

encouraged (see below). 

SUPPLEMENTARY INFORMATION: Pursuant 

to Public Law 109–129, 42 U.S.C. 274k 

(section 379 of the Public Health Service 

Act, as amended), the ACBSCT was 

established to advise the Secretary of 

HHS and the Administrator, HRSA, on 

matters related to the activities of the 

C.W. Bill Young Cell Transplantation 

Program (Program) and the National 

Cord Blood Inventory (NCBI) Program. 

ACBSCT is composed of up to 25 

members, including the Chair, serving 

as Special Government Employees. The 

current membership includes 

representatives of marrow donor centers 

and marrow transplant centers; 

representatives of cord blood banks and 

participating birthing hospitals; 

recipients of a bone marrow transplant; 

recipients of a cord blood transplant; 

persons who require such transplants; 

family members of such a recipient or 

family members of a patient who has 

requested the assistance of the Program 

in searching for an unrelated donor of 

bone marrow or cord blood; persons 

with expertise in bone marrow and cord 

blood transplantation; persons with 

expertise in typing, matching, and 

transplant outcome data analysis; 

persons with expertise in the social 

sciences; basic scientists with expertise 

in the biology of adult stem cells; 

ethicists; hematology and transfusion 

medicine researchers with expertise in 

adult blood stem cells; persons with 

expertise in cord blood processing; and 

members of the general public. 

The Council will hear reports from 

three ACBSCT Work Groups: Cord 

Blood Accreditation Organization and 

Recognition Process, Scientific Factors 

Necessary to Define a Cord Blood Unit 

as High Quality, and Informed Consent. 

The Council also will hear presentations 

and discussions on the following topics: 

recent clinical developments and 

current issues, adult donor recruitment: 

Strategies and challenges, and future 

council activities. 

The draft meeting agenda and a 

registration form will be available on or 

about April 13, 2009, on HRSA’s 

Program Web site at http:// 

bloodcell.transplant.hrsa.gov/ABOUT/ 


rwilkins on PROD1PC63 with NOTICES