Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability, 33311-33312 [2010-14036]

Download as PDF 33311 Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Notices Responses per respondent Number of respondents Type of application form Total responses Hours per response Total burden hours Business Plan (Non-Competing) ....................................... Services Provided .............................................................. Sites Listing ........................................................................ Other Site Activities ........................................................... Change In Scope (CIS) Site Add Checklist ....................... CIS Site Delete Checklist .................................................. CIS Relocation Checklist ................................................... CIS Service Add Checklist ................................................. CIS Service Delete Checklist ............................................. Board Member Characteristics .......................................... 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Sahira Rafiullah, Director, Division of Policy and Information Coordination. [FR Doc. 2010–14108 Filed 6–10–10; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0433] (formerly Docket No. 2007D–0169) Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability AGENCY: Food and Drug Administration, WReier-Aviles on DSKGBLS3C1PROD with NOTICES HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products.’’ This guidance describes a new process for making available VerDate Mar<15>2010 15:04 Jun 10, 2010 Jkt 220001 recommendations on how to design product-specific bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). Under this process, applicants planning to carry out such studies in support of their ANDAs are able to access BE study guidance on the FDA Web site. FDA believes that making this information available on the Internet will streamline the guidance process and will provide a meaningful opportunity for the public to consider and comment on productspecific BE study recommendations. DATES: Submit either electronic or written comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of this 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. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://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: Doan T. Nguyen, Center for Drug Evaluation and Research (HFD–600), PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240– 276–9314. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products.’’ This guidance describes a new process for making available recommendations on how to design product-specific BE studies to support ANDAs. Under this process, draft and final BE recommendations are posted on FDA’s Web site (https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, Individual Product Bioequivalence Recommendations) and announced periodically in the Federal Register. For draft BE recommendations, the Federal Register notice will identify a comment period. The public is encouraged to submit comments on the draft BE recommendations, and the agency will consider received comments in developing final BE recommendations. FDA adopted this process as a means to develop and disseminate productspecific BE recommendations and provide an opportunity for the public to consider and comment on those recommendations. In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced the availability of a draft version of this guidance entitled ‘‘Bioequivalence Recommendations for Specific E:\FR\FM\11JNN1.SGM 11JNN1 33312 Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Notices Products.’’ The May 2007 draft guidance gave interested persons an opportunity to submit comments through August 29, 2007. The agency is finalizing the guidance after considering comments received on the draft guidance. Minor changes were made to the draft guidance to update FDA Web site information. 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 a new process for making available to sponsors FDA guidance on how to design productspecific bioequivalence studies to support ANDAs. 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 the guidance. 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. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: June 3, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–14036 Filed 6–10–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration WReier-Aviles on DSKGBLS3C1PROD with NOTICES [Docket No. FDA–2010–N–0256] Indexing Structured Product Labeling for Human Prescription Drug and Biological Products; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. VerDate Mar<15>2010 15:04 Jun 10, 2010 Jkt 220001 SUMMARY: The Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are indexing certain categories of information in product labeling for use as terms to search repositories of approved prescription medical product structured product labeling (SPL). FDA has previously identified pharmacologic class as a top priority for indexing of product labeling information. FDA is now announcing that medical product indications is another category of product labeling information that the agency has identified as a high priority for indexing. CDER and CBER are announcing the establishment of a public docket to provide an opportunity for interested parties to share information, research, and ideas on the FDA indexing process. DATES: Submit either electronic or written comments by August 10, 2010. ADDRESSES: Submit electronic comments to https:// 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. All comments should be identified with the docket number found in the brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Colleen E. Brennan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6439, Silver Spring, MD 20993–0002, 301– ´ 796–2316; or Denise Sanchez, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background As part of the effort to advance medical informatics to support the safe use of medical products, CDER and CBER are using the SPL format to index labeling information for human prescription drug and biological products. SPL is a document markup standard approved by Health Level Seven adopted by FDA as a mechanism for exchanging product information by using extensible markup language. Indexing refers to the insertion of machine-readable tags that do not appear in actual printed labeling, but enable users with clinical decision support tools and electronic prescribing systems to rapidly search and sort product information. This is an important step toward the creation of a PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 fully automated health information exchange system. Indexed labeling can help prevent prescription errors and enhance the safe use of medical products. For example, among other benefits, the SPL indexing can enable a hospital’s computer system to help detect that products prescribed by the hospital to treat a patient’s injury do not adversely interact with other products that the patient is taking. It is important that this indexing be done consistently to enable comprehensive searches to find all relevant information, including appropriate synonyms. In recent years, FDA pilot-tested the addition of SPL indexing to human prescription drug and biological product labeling. Based on that experience, feedback from industry, and feedback from other SPL users, FDA’s approach will be to index product labeling information and link an indexed SPL file to the content of labeling SPL file available in the official SPL public access repository. Considering FDA’s available resources, we have instituted a phased implementation of indexing for certain categories for all human prescription drug and biological product labeling. Indexing information on the pharmacologic class and indications categories of product labeling is being undertaken by the agency, as resources permit (see more information below). As the phased implementation proceeds, all human prescription drug and biological product labeling may be linked to certain key indexing. For additional information, including the guidance for industry ‘‘Indexing Structured Product Labeling,’’ refer to the FDA Data Standards Council Web page on SPL at https://www.fda.gov/ ForIndustry/DataStandards/Structured ProductLabeling/default.htm. FDA will update the Data Standards Council Web site to include all SPL indexing and their related terminologies as they are developed. When the indexing of pharmacologic class and indications is complete, FDA intends to index other categories of product labeling information using a phased implementation process. The types and priority order of indexing of subsequent categories will be determined based on public input and agency priorities. II. Indexing Pharmacologic Class In June 2008, FDA issued the guidance for industry ‘‘Indexing Structured Product Labeling.’’ This guidance states the agency’s intention to index product labeling information, as resources permit, and identifies pharmacologic class as a top indexing priority. As part of its review and label E:\FR\FM\11JNN1.SGM 11JNN1

Agencies

[Federal Register Volume 75, Number 112 (Friday, June 11, 2010)]
[Notices]
[Pages 33311-33312]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14036]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0433] (formerly Docket No. 2007D-0169)


Guidance for Industry on Bioequivalence Recommendations for 
Specific Products; 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 ``Bioequivalence 
Recommendations for Specific Products.'' This guidance describes a new 
process for making available recommendations on how to design product-
specific bioequivalence (BE) studies to support abbreviated new drug 
applications (ANDAs). Under this process, applicants planning to carry 
out such studies in support of their ANDAs are able to access BE study 
guidance on the FDA Web site. FDA believes that making this information 
available on the Internet will streamline the guidance process and will 
provide a meaningful opportunity for the public to consider and comment 
on product-specific BE study recommendations.

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

ADDRESSES:  Submit written requests for single copies of this 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. Send one self-addressed 
adhesive label to assist that office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on the guidance to https://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: Doan T. Nguyen, Center for Drug 
Evaluation and Research (HFD-600), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9314.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Bioequivalence Recommendations for Specific Products.'' This 
guidance describes a new process for making available recommendations 
on how to design product-specific BE studies to support ANDAs. Under 
this process, draft and final BE recommendations are posted on FDA's 
Web site (https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, 
Individual Product Bioequivalence Recommendations) and announced 
periodically in the Federal Register. For draft BE recommendations, the 
Federal Register notice will identify a comment period. The public is 
encouraged to submit comments on the draft BE recommendations, and the 
agency will consider received comments in developing final BE 
recommendations. FDA adopted this process as a means to develop and 
disseminate product-specific BE recommendations and provide an 
opportunity for the public to consider and comment on those 
recommendations.
    In the Federal Register of May 31, 2007 (72 FR 30388), FDA 
announced the availability of a draft version of this guidance entitled 
``Bioequivalence Recommendations for Specific

[[Page 33312]]

Products.'' The May 2007 draft guidance gave interested persons an 
opportunity to submit comments through August 29, 2007. The agency is 
finalizing the guidance after considering comments received on the 
draft guidance. Minor changes were made to the draft guidance to update 
FDA Web site information.
    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 a new process for making available to 
sponsors FDA guidance on how to design product-specific bioequivalence 
studies to support ANDAs. 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 the 
guidance. 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. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: June 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-14036 Filed 6-10-10; 8:45 am]
BILLING CODE 4160-01-S
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