Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances; Availability, 78366-78367 [2013-30800]

Download as PDF 78366 Federal Register / Vol. 78, No. 248 / Thursday, December 26, 2013 / Notices burden for this information collection is 37 hours. Dated: December 20, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–30804 Filed 12–24–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1615] Draft Generic Drug User Fee Act Information Technology Plan; Availability for Comment AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability for public comment of the draft information technology (IT) plan entitled ‘‘GDUFA Information Technology Plan.’’ This plan is intended to provide FDA’s approach for enhancing business processes, data quality and consistency, supporting technologies, and IT operations as described in the Generic Drug User Fee Act (GDUFA) Performance Goals and Procedures for Fiscal Years 2013 through 2017. FDA is publishing a draft version of the IT plan for comment to allow industry and other interested stakeholders to provide feedback as FDA moves towards a fully automated standards-based environment that enhances the regulatory review process for human pharmaceuticals. DATES: Submit either electronic or written comments by February 24, 2014. ADDRESSES: Submit written requests for single copies of the draft ‘‘GDUFA Information Technology Plan’’ 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 draft plan. Submit electronic comments on the draft plan 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: Cheryl Ford, Center for Drug Evaluation emcdonald on DSK67QTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:06 Dec 24, 2013 Jkt 232001 and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–6737, UserFeesProgramInformatics@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Signed into law on July 9, 2012, GDUFA is designed to speed the delivery of safe and effective generic drugs to the public. GDUFA increases FDA’s authorities and responsibilities to address issues such as drug shortages, drug supply chain, safety, security, and drug innovation. As generic drugs account for more than three-quarters of all prescriptions dispensed in the United States, GDUFA authorizes FDA to collect user fees from industry that will provide funding to expand and modernize FDA’s generic drug regulatory process. The draft GDUFA IT plan considers assumptions, available resources, and statutory requirements that conform to the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012. Section 1136 of FDASIA, Electronic Submission of Applications, gives FDA the authority to require a standardized electronic format for the submission of information and data in standardized formats. Section 1136 addresses abbreviated new drug applications under the GDUFA program as well as investigational new drug applications, biologics license applications, and new drug applications under the Prescription Drug User Fee Act program and describes new standards and processes affecting drug and biologics approvals, drug supply chain, and other topics related to human pharmaceuticals. The draft GDUFA IT plan describes key activities for enabling progress toward achieving GDUFA IT goals. II. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at http:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/ForIndustry/ PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 UserFees/default.htm or http:// www.regulations.gov. Dated: December 20, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–31008 Filed 12–24–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–1566] Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Naming of Drug Products Containing Salt Drug Substances.’’ The United States Pharmacopeial (U.S.P.) Convention has adopted a monograph naming policy that changed the nomenclature for compendial drug products that contain a salt. Under the new policy, drug names and strengths for new compendial drug products will be based on the active moiety. The name and strength of the active ingredient (e.g., salt) will appear elsewhere on the drug product label and labeling. The policy became official on May 1, 2013. This draft guidance describes the U.S.P. policy, discusses the Center for Drug Evaluation and Research’s (CDER’s) application of the policy, and recommends how CDER and industry can implement the policy. 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 either electronic or written comments on the draft guidance by March 26, 2014. ADDRESSES: 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. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. SUMMARY: E:\FR\FM\26DEN1.SGM 26DEN1 Federal Register / Vol. 78, No. 248 / Thursday, December 26, 2013 / Notices emcdonald on DSK67QTVN1PROD with NOTICES Submit electronic comments on the draft 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: Richard Lostritto, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20993, 301–796–1697, NewDrugCMC@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Naming of Drug Products Containing Salt Drug Substances.’’ This draft guidance is being published to explain how CDER is implementing the U.S.P.’s policy entitled ‘‘Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations.’’ It is a naming and labeling policy applicable to drug products that contain an active ingredient that is a salt. The policy stipulates that U.S.P. will use the name of the active moiety, instead of the name of the salt when creating a drug product monograph title, and the strength will be expressed in terms of the active moiety. The policy allows for exceptions under specified circumstances. CDER is now applying this policy to new prescription drug products under development under section 505 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355). FDA is separately considering applying the U.S.P. Salt Policy to nonprescription drug products, and to biological products licensed under the Public Health Service Act. The U.S.P. Salt Policy became official on May 1, 2013, and U.S.P. is now applying it to all new drug product monographs for products that contain an active ingredient that is a salt. It affects the development of new drug products, because a U.S.P. monograph title for a new drug product, in most instances, serves as the nonproprietary, or ‘‘established’’ name of the related drug product (section 502(e)(3) of the FD&C Act (21 U.S.C. 352(e)(3)). If a drug product’s label or labeling contains a name that is inconsistent with the applicable monograph title, it risks being misbranded (section 502(e)(1)(A)(i) of the FD&C Act). This draft guidance describes the U.S.P. policy and discusses how CDER and industry can implement the policy. VerDate Mar<15>2010 18:06 Dec 24, 2013 Jkt 232001 Following the policy will help reduce medication errors caused by a mismatch between the established name and strength on the label of drug products that contain a salt. More accurate naming of drug products containing a salt helps health care practitioners calculate equivalent doses when changing from one dosage form to another. 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 CDER’s current thinking on drug product naming nomenclature for new drugs that contain a salt as the active ingredient. 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 This draft guidance includes information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (the PRA) of 1995 (44 U.S.C. 3501–3520). The collections of information referenced in this draft guidance that are related to the burden for the submission of investigational new drug applications are covered under 21 CFR 312 and have been approved under OMB control number 0910–0014. The collections of information referenced in this draft guidance that are related to the burden for the submission of new drug applications are covered under 21 CFR 314 have been approved under OMB control number 0910–0001. The submission of prescription drug product labeling under 21 CFR 201.56 and 201.57 is approved under OMB control number 0910–0572. In accordance with the PRA, prior to publication of any final guidance document, FDA intends to solicit public comment and obtain OMB approval for any information collections recommended in this guidance that are new or that would represent material modifications to those previously approved collections of information found in FDA regulations or guidances. III. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 78367 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, and will be posted to the docket at http:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/Guidances/default.htm or http://www.regulations.gov. Dated: December 19, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–30800 Filed 12–24–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1618] Draft Prescription Drug User Fee Act V Information Technology Plan; Availability for Comment AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability for public comment of the draft information technology (IT) plan entitled ‘‘PDUFA V Information Technology Plan.’’ This plan is intended to provide FDA’s approach for enhancing business processes, data quality and consistency, supporting technologies, and IT operations as described in the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2013 through 2017. FDA is publishing a draft version of the IT plan for comment to allow industry and other interested stakeholders to provide feedback as FDA moves towards a fully automated standards-based environment that enhances the regulatory review process for human pharmaceuticals. DATES: Submit either electronic or written comments by February 24, 2014. ADDRESSES: Submit written requests for single copies of the draft ‘‘PDUFA V Information Technology Plan’’ 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 SUMMARY: E:\FR\FM\26DEN1.SGM 26DEN1

Agencies

[Federal Register Volume 78, Number 248 (Thursday, December 26, 2013)]
[Notices]
[Pages 78366-78367]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30800]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1566]


Draft Guidance for Industry on Naming of Drug Products Containing 
Salt Drug Substances; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Naming of Drug 
Products Containing Salt Drug Substances.'' The United States 
Pharmacopeial (U.S.P.) Convention has adopted a monograph naming policy 
that changed the nomenclature for compendial drug products that contain 
a salt. Under the new policy, drug names and strengths for new 
compendial drug products will be based on the active moiety. The name 
and strength of the active ingredient (e.g., salt) will appear 
elsewhere on the drug product label and labeling. The policy became 
official on May 1, 2013. This draft guidance describes the U.S.P. 
policy, discusses the Center for Drug Evaluation and Research's 
(CDER's) application of the policy, and recommends how CDER and 
industry can implement the policy.

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 either electronic or written comments on the draft 
guidance by March 26, 2014.

ADDRESSES: 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. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

[[Page 78367]]

    Submit electronic comments on the draft 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: Richard Lostritto, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD, 20993, 301-796-1697, 
NewDrugCMC@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Naming of Drug Products Containing Salt Drug Substances.'' 
This draft guidance is being published to explain how CDER is 
implementing the U.S.P.'s policy entitled ``Monograph Naming Policy for 
Salt Drug Substances in Drug Products and Compounded Preparations.'' It 
is a naming and labeling policy applicable to drug products that 
contain an active ingredient that is a salt. The policy stipulates that 
U.S.P. will use the name of the active moiety, instead of the name of 
the salt when creating a drug product monograph title, and the strength 
will be expressed in terms of the active moiety. The policy allows for 
exceptions under specified circumstances. CDER is now applying this 
policy to new prescription drug products under development under 
section 505 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
(21 U.S.C. 355). FDA is separately considering applying the U.S.P. Salt 
Policy to nonprescription drug products, and to biological products 
licensed under the Public Health Service Act.
    The U.S.P. Salt Policy became official on May 1, 2013, and U.S.P. 
is now applying it to all new drug product monographs for products that 
contain an active ingredient that is a salt. It affects the development 
of new drug products, because a U.S.P. monograph title for a new drug 
product, in most instances, serves as the nonproprietary, or 
``established'' name of the related drug product (section 502(e)(3) of 
the FD&C Act (21 U.S.C. 352(e)(3)). If a drug product's label or 
labeling contains a name that is inconsistent with the applicable 
monograph title, it risks being misbranded (section 502(e)(1)(A)(i) of 
the FD&C Act).
    This draft guidance describes the U.S.P. policy and discusses how 
CDER and industry can implement the policy. Following the policy will 
help reduce medication errors caused by a mismatch between the 
established name and strength on the label of drug products that 
contain a salt. More accurate naming of drug products containing a salt 
helps health care practitioners calculate equivalent doses when 
changing from one dosage form to another.
    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 CDER's current thinking on drug product 
naming nomenclature for new drugs that contain a salt as the active 
ingredient. 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

    This draft guidance includes information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act (the PRA) of 1995 (44 U.S.C. 3501-
3520). The collections of information referenced in this draft guidance 
that are related to the burden for the submission of investigational 
new drug applications are covered under 21 CFR 312 and have been 
approved under OMB control number 0910-0014. The collections of 
information referenced in this draft guidance that are related to the 
burden for the submission of new drug applications are covered under 21 
CFR 314 have been approved under OMB control number 0910-0001. The 
submission of prescription drug product labeling under 21 CFR 201.56 
and 201.57 is approved under OMB control number 0910-0572.
    In accordance with the PRA, prior to publication of any final 
guidance document, FDA intends to solicit public comment and obtain OMB 
approval for any information collections recommended in this guidance 
that are new or that would represent material modifications to those 
previously approved collections of information found in FDA regulations 
or guidances.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

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

    Dated: December 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30800 Filed 12-24-13; 8:45 am]
BILLING CODE 4160-01-P