International Conference on Harmonisation; Draft Guidance on S9 Nonclinical Evaluation for Anticancer Pharmaceuticals; Availability, 7445-7446 [E9-3168]

Download as PDF Federal Register / Vol. 74, No. 30 / Tuesday, February 17, 2009 / Notices Grandparents raising grandchildren; Foster Parent Training; Family strengthening services to individuals with substance abuse issues; Public Advertising Campaigns; Research (3) Native Language Preservation & Maintenance Assessment Data Collection; Formal Language Assessment; Informal Language Assessment (4) Native Language Preservation & Maintenance Planning Plan & design Master/Apprentice programs; Plan & design comprehensive Native language immersion programs for a language nest or survival school; Plan, design & test curriculum for students, parents & language instructors; Plan & design teaching materials; Record, transcribe & archive oral testimony; Plan & design language resource materials using recorded oral testimony; Plan & design multi-media language learning tools; Plan & design teacher certification programs; Train teachers, interpreters or translators of Native languages 7445 teaching of Native American language skills; Disseminate culturally relevant materials to teach & enhance the use of Native American languages; Implement an immersion, mentor or distance learning model; Produce, distribute or participate in various media forms to broadcast Native languages; Implement an educational site-based immersion project (5) Native Language Preservation & Maintenance Implementation (6) Native Language Preservation & Maintenance ImmersionLanguage Nest; Language Survival School Produce/disseminate culturally relevant printed stories for children using the Native language of the community; Facilitate/encourage intergenerational Respondents: Federally Recognized Indian Tribes, Tribal Governments, Native American Non-profits, Tribal Colleges and Universities ANNUAL BURDEN ESTIMATES Number of respondents Number of responses per respondent Average burden hours per response Total burden hours Grant Application Data Summary (GADS) ...................................................... sroberts on PROD1PC70 with NOTICES Instrument 500 1 0.50 250 Estimated Total Annual Burden Hours: 250. In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. VerDate Nov<24>2008 19:45 Feb 13, 2009 Jkt 217001 Dated: February 11, 2009. Janean Chambers, Reports Clearance Officer. [FR Doc. E9–3240 Filed 2–13–09; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0006] International Conference on Harmonisation; Draft Guidance on S9 Nonclinical Evaluation for Anticancer Pharmaceuticals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘S9 Nonclinical Evaluation for Anticancer Pharmaceuticals.’’ The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides recommendations for nonclinical studies for the development of pharmaceuticals, including both drugs and biotechnology-derived products, intended to treat patients with advanced cancer. The recommendations describe the type and timing of nonclinical studies to support an investigational PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 new drug application (IND) and the submission of a new drug application (NDA) or biologics license application (BLA). The draft guidance is intended to provide information on internationally accepted recommendations for nonclinical studies to facilitate the development of anticancer pharmaceuticals. 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 written or electronic comments on the draft guidance by April 20, 2009. ADDRESSES: 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 https:// www.regulations.gov. 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 (CBER), Food and Drug Administration, 1401 Rockville Pike, 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 E:\FR\FM\17FEN1.SGM 17FEN1 7446 Federal Register / Vol. 74, No. 30 / Tuesday, February 17, 2009 / Notices assist the office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: John K. Leighton, Center for Drug Evaluation and Research (HFD–106), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 2204, Silver Spring, MD 20993–0002, 301– 796–2330; or Mercedes Serabian, Center for Biologics Evaluation and Research (HFM–760), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448, 301–827– 5377. 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: sroberts on PROD1PC70 with NOTICES 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). VerDate Nov<24>2008 19:45 Feb 13, 2009 Jkt 217001 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 November 2008, the ICH Steering Committee agreed that a draft guidance entitled ‘‘S9 Nonclinical Evaluation for Anticancer Pharmaceuticals’’ should be made available for public comment. The draft guidance is the product of the Safety Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Safety Expert Working Group. The draft guidance provides guidance for nonclinical studies for the development of pharmaceuticals, including both drugs and biotechnology-derived products, intended to treat patients with advanced cancer. The recommendations describe the type and timing of nonclinical studies to support an IND and the submission of an NDA or BLA. 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 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 on 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. Electronic Access Persons with access to the Internet may obtain the document at https:// www.regulations.gov, https:// www.fda.gov/cder/guidance/index.htm, or https://www.fda.gov/cber/ guidelines.htm. Dated: February 6, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–3168 Filed 2–13–09; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0013] International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Sterility Test General Chapter; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 8: Sterility Test General Chapter.’’ The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Sterility Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This draft guidance is the eighth annex to the core Q4B guidance, which was made available in the Federal Register of February 21, 2008 (73 FR 9575). 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 written or electronic comments on the draft guidance by April 20, 2009. 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, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, E:\FR\FM\17FEN1.SGM 17FEN1

Agencies

[Federal Register Volume 74, Number 30 (Tuesday, February 17, 2009)]
[Notices]
[Pages 7445-7446]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-3168]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0006]


International Conference on Harmonisation; Draft Guidance on S9 
Nonclinical Evaluation for Anticancer Pharmaceuticals; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``S9 Nonclinical Evaluation 
for Anticancer Pharmaceuticals.'' The draft guidance was prepared under 
the auspices of the International Conference on Harmonisation of 
Technical Requirements for Registration of Pharmaceuticals for Human 
Use (ICH). The draft guidance provides recommendations for nonclinical 
studies for the development of pharmaceuticals, including both drugs 
and biotechnology-derived products, intended to treat patients with 
advanced cancer. The recommendations describe the type and timing of 
nonclinical studies to support an investigational new drug application 
(IND) and the submission of a new drug application (NDA) or biologics 
license application (BLA). The draft guidance is intended to provide 
information on internationally accepted recommendations for nonclinical 
studies to facilitate the development of anticancer pharmaceuticals.

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 written or electronic comments on the draft guidance 
by April 20, 2009.

ADDRESSES: 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 https://www.regulations.gov. 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 
(CBER), Food and Drug Administration, 1401 Rockville Pike, 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

[[Page 7446]]

assist the office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: John K. 
Leighton, Center for Drug Evaluation and Research (HFD-106), Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 2204, 
Silver Spring, MD 20993-0002, 301-796-2330; or Mercedes Serabian, 
Center for Biologics Evaluation and Research (HFM-760), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
5377.
    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 November 2008, the ICH Steering Committee agreed that a draft 
guidance entitled ``S9 Nonclinical Evaluation for Anticancer 
Pharmaceuticals'' should be made available for public comment. The 
draft guidance is the product of the Safety Expert Working Group of the 
ICH. Comments about this draft will be considered by FDA and the Safety 
Expert Working Group.
    The draft guidance provides guidance for nonclinical studies for 
the development of pharmaceuticals, including both drugs and 
biotechnology-derived products, intended to treat patients with 
advanced cancer. The recommendations describe the type and timing of 
nonclinical studies to support an IND and the submission of an NDA or 
BLA.
    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 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 on 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. Electronic Access

    Persons with access to the Internet may obtain the document at 
https://www.regulations.gov, https://www.fda.gov/cder/guidance/index.htm, 
or https://www.fda.gov/cber/guidelines.htm.

    Dated: February 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3168 Filed 2-13-09; 8:45 am]
BILLING CODE 4160-01-S

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