Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products-Submitting New Drug Applications; Availability, 19524-19525 [E6-5528]

Download as PDF 19524 Federal Register / Vol. 71, No. 72 / Friday, April 14, 2006 / Notices wwhite on PROD1PC65 with NOTICES SUMMARY: The Food and Drug Administration (FDA) is planning a public meeting on FDA-regulated products containing nanotechnology materials. The purpose of the meeting will be to help FDA further its understanding of developments in nanotechnology materials that pertain to FDA-regulated products. FDA is interested in learning about the kinds of new nanotechnology material products under development in the areas of foods (including dietary supplements), food and color additives, animal feeds, cosmetics, drugs and biologics, and medical devices; whether there are scientific issues that should be addressed; and any other issues about which the regulated industry, academia and the interested public may wish to inform FDA concerning the use of nanotechnology materials in FDAregulated products. DATES AND TIMES: The public meeting will be held in mid-October 2006. Details on the date and time of the meeting will be provided in a subsequent Federal Register notice. ADDRESSES: The public workshop will be held in the Washington, DC metropolitan area. The meeting address will be provided in a subsequent Federal Register notice and posted at https://www.fda.gov/nanotechnology. 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 https://www.fda.gov/dockets/ ecomments. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: For information about this document: Poppy Kendall, Food and Drug Administration (HF–11), 5600 Fishers Lane, Rockville, MD 20857, 301–827–3360, FAX: 301–594– 6777, e-mail: Poppy.Kendall@FDA.HHS.Gov. SUPPLEMENTARY INFORMATION: I. Why Are We Holding a Public Meeting? Nanotechnology is defined in a variety of ways. The National Nanotechnology Initiative (a U.S. Government research and development coordinating program) refers to nanotechnology as ‘‘the understanding and control of matter at dimensions of roughly 1 to 100 nanometers, where unique phenomena enable novel applications’’ (https://www.nano.gov). A nanometer is a billionth of a meter, and is approximately the width of 10 VerDate Aug<31>2005 16:37 Apr 13, 2006 Jkt 208001 hydrogen atoms lined up side by side. (A human hair is about 80,000 nanometers in width. Deoxyribonucleic acid (DNA) is about 2.5 nanometers in width.) Due to their small size and extremely high ratio of surface area to volume, nanotechnology materials often have chemical or physical properties that are different from those of their larger counterparts. Such differences include altered magnetic properties, altered electrical or optical activity, increased structural integrity, and increased chemical and biological activity. Because of these properties, nanotechnology materials have great potential for use in a vast array of products. Also because of some of their special properties, they may pose different safety issues than their larger counterparts. Of particular interest to FDA, nanotechnology materials may enable new developments in implants and prosthetics, drug delivery, and food processing, and may already be in use in some cosmetics and sunscreens. As part of its critical path initiative, FDA is interested in learning if there are opportunities for it to help overcome scientific hurdles that may be inhibiting the use of nanotechnology in medical product development. We will be holding this meeting because we are interested in learning about the kinds of new nanotechnology material products under development in the areas of foods (including dietary supplements), food and color additives, animal feeds, cosmetics, drugs and biologics, and medical devices; whether there are scientific issues that should be addressed; and any other issues about which the regulated industry, academia and the interested public may wish to inform FDA concerning the use of nanotechnology materials in FDAregulated products. For more information about FDA’s role regarding nanotechnology products, see our Web page at https://www.fda.gov/ nanotechnology. We are announcing our plans now to hold a meeting to give ourselves and participants ample time to prepare. II. How Can You Participate? Details on registration and the meeting agenda will be provided in a subsequent Federal Register notice and at https://www.fda.gov/nanotechnology. To help us plan the logistics and agenda for the meeting, we would appreciate receiving expressions of interest from those planning on attending or presenting at the meeting, via e-mail or phone to Poppy Kendall (see FOR FURTHER INFORMATION CONTACT). We will attempt to obtain a venue and structure PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 the meeting to accommodate the level of expressed interest and to address a range of topics, but will not begin the registration process until after publication of the subsequent Federal Register notice. III. How Should You Send Comments on the Issues? Interested persons may submit written or electronic comments to the Division of Dockets Management (see ADDRESSES). 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. Dated: March 21, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–5526 Filed 4–13–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003D–0206] Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products—Submitting New Drug Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Exocrine Pancreatic Insufficiency Drug Products— Submitting NDAs.’’ This guidance is intended to assist manufacturers of exocrine pancreatic insufficiency drug products in preparing and submitting documentation to meet new drug application (NDA) requirements for the drug products. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of this 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 E:\FR\FM\14APN1.SGM 14APN1 Federal Register / Vol. 71, No. 72 / Friday, April 14, 2006 / Notices wwhite on PROD1PC65 with NOTICES office in processing your requests. 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 https:// www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Maureen Dewey, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5195, Silver Spring, MD 20993–0002, 301– 796–0845. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Exocrine Pancreatic Insufficiency Drug Products—Submitting NDAs.’’ On April 28, 2004 (69 FR 23410), FDA announced that all exocrine pancreatic insufficiency drug products are new drugs and that manufacturers who wish to continue to market these products must submit applications as required by section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) and 21 CFR part 314. The Federal Register announcement stated that FDA is prepared to accept NDAs for these products, including applications submitted under section 505(b)(2) of the act. This guidance is intended to assist manufacturers of currently marketed exocrine pancreatic insufficiency drug products in preparing and submitting documentation to meet NDA requirements for the drug products. Also on April 28, 2004 (69 FR 23414), FDA announced the availability of the draft version of this guidance. A number of comments were received, and the agency considered them carefully as it finalized the guidance. Although the guidance has not changed substantially, the following changes are noteworthy: (1) In the Background section, the scope of the guidance was clarified; (2) in the Chemistry, Manufacturing, and Controls section, several items were further explained; (3) in the Nonclinical Pharmacology and Toxicology section, two points were additionally clarified; (4) in the Safety subsection, the recommended dosage was updated; and (5) in the References section, two additional references were added and one reference was deleted. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’s VerDate Aug<31>2005 16:37 Apr 13, 2006 Jkt 208001 current thinking on submitting NDAs for exocrine pancreatic insufficiency drug products. 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 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. III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/cder/guidance/ index.htm or https://www.fda.gov/ ohrms/dockets/default.htm. Dated: April 6, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–5528 Filed 4–13–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D–0139] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Revised Guidance for Industry on Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision); Request for Comments; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability for comment of a draft revised guidance for industry (#73) entitled ‘‘Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision)’’ VICH GL3(R). This draft revised guidance, which updates a guidance on the same topic for which a notice of availability PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 19525 was published in the Federal Register of October 12, 1999 (64 FR 55293) (the 1999 guidance), has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft revised document is intended to provide guidance regarding the development of stability testing data new animal drug applications (referred to as registration applications in the guidance) submitted to the European Union (EU), Japan, and United States. DATES: Submit written or electronic comments by May 15, 2006 to ensure their adequate consideration in preparation of the final document. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine (CVM), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. 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.fda.gov/dockets/ecomments. Comments should be identified with the full title of the guidance and the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Dennis Bensley, Center for Veterinary Medicine, (HFV–143), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–6956, email: dennis.bensley@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote the international harmonization of regulatory requirements. FDA has participated in efforts to enhance harmonization and has expressed its commitment to seek scientifically based harmonized technical procedures for the development of pharmaceutical products. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies in different countries. E:\FR\FM\14APN1.SGM 14APN1

Agencies

[Federal Register Volume 71, Number 72 (Friday, April 14, 2006)]
[Notices]
[Pages 19524-19525]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-5528]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0206]


Guidance for Industry on Exocrine Pancreatic Insufficiency Drug 
Products--Submitting New Drug Applications; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Exocrine Pancreatic 
Insufficiency Drug Products--Submitting NDAs.'' This guidance is 
intended to assist manufacturers of exocrine pancreatic insufficiency 
drug products in preparing and submitting documentation to meet new 
drug application (NDA) requirements for the drug products.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this 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 self-addressed adhesive label to 
assist that

[[Page 19525]]

office in processing your requests. 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 https://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT: Maureen Dewey, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 5195, Silver Spring, MD 20993-0002, 301-
796-0845.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Exocrine Pancreatic Insufficiency Drug Products--Submitting 
NDAs.'' On April 28, 2004 (69 FR 23410), FDA announced that all 
exocrine pancreatic insufficiency drug products are new drugs and that 
manufacturers who wish to continue to market these products must submit 
applications as required by section 505 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 355) and 21 CFR part 314. The Federal 
Register announcement stated that FDA is prepared to accept NDAs for 
these products, including applications submitted under section 
505(b)(2) of the act. This guidance is intended to assist manufacturers 
of currently marketed exocrine pancreatic insufficiency drug products 
in preparing and submitting documentation to meet NDA requirements for 
the drug products.
    Also on April 28, 2004 (69 FR 23414), FDA announced the 
availability of the draft version of this guidance. A number of 
comments were received, and the agency considered them carefully as it 
finalized the guidance. Although the guidance has not changed 
substantially, the following changes are noteworthy: (1) In the 
Background section, the scope of the guidance was clarified; (2) in the 
Chemistry, Manufacturing, and Controls section, several items were 
further explained; (3) in the Nonclinical Pharmacology and Toxicology 
section, two points were additionally clarified; (4) in the Safety 
subsection, the recommended dosage was updated; and (5) in the 
References section, two additional references were added and one 
reference was deleted.
    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 submitting NDAs for exocrine pancreatic 
insufficiency drug products. 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 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/cder/guidance/index.htm or https://
www.fda.gov/ohrms/dockets/default.htm.

    Dated: April 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-5528 Filed 4-13-06; 8:45 am]
BILLING CODE 4160-01-S

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