Guidance for Industry on Labeling for Human Prescription Drug and Biological Products-Implementing the Physician Labeling Rule Content and Format Requirements; Availability, 12760-12761 [2013-04195]

Download as PDF 12760 Federal Register / Vol. 78, No. 37 / Monday, February 25, 2013 / Notices INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to http:// www.regulations.gov.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. Lisa K. Naeger, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6366, Silver Spring, MD 20993–0002, 301–796–0771. FOR FURTHER INFORMATION CONTACT: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Attachment to Guidance on Antiviral Product Development—Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HCV Resistance Data.’’ The purpose of this attachment is to assist sponsors in submitting HCV clinical virology data, which are important for supporting clinical trials of products in development for the treatment of HCV. This attachment revises and replaces the attachment on submitting HCV resistance data published in June 2006 and represents FDA’s current thinking regarding how sponsors should submit HCV resistance data. The revised attachment provides the format, recommended definitions, standardization of column headings and variables, and recommended data for submission of HCV resistance datasets. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on submitting HCV clinical virology data. 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. mstockstill on DSK4VPTVN1PROD with NOTICES II. The Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910–0014. 17:22 Feb 22, 2013 Jkt 229001 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 SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 III. Comments Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http://www. regulations.gov. Dated: February 19, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–04196 Filed 2–22–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2005–D–0153; formerly 2005D–0011] Guidance for Industry on Labeling for Human Prescription Drug and Biological Products—Implementing the Physician Labeling Rule Content and Format Requirements; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Labeling for Human Prescription Drug and Biological Products—Implementing the PLR Content and Format Requirements.’’ This guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological products. The recommendations in this guidance will help ensure that the labeling is clear; useful; informative; and to the extent possible, consistent in content and format. It will assist applicants in developing labeling for new products, revising existing labeling, and implementing the requirements on content and format of labeling for SUMMARY: PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 human prescription drug and biological products (71 FR 3922), which appeared in the Federal Register of January 24, 2006. The rule is commonly referred to as the ‘‘Physician Labeling Rule’’ (PLR) because it addresses prescription drug labeling that is used by prescribers and other health care practitioners. 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 or 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. 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 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: Lori Bickel, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6353, Silver Spring, MD 20993–0002, 301–796–0210; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Labeling for Human Prescription Drug and Biological Products—Implementing the PLR Content and Format Requirements.’’ The guidance provides recommendations on how to create professional labeling consistent with the requirements on content and format of labeling for human prescription drug and biological products under §§ 201.56 and 201.57 (21 CFR 201.56 and 201.57) (71 FR 3922). The guidance also provides recommendations on how to organize labeling sections and what information should be included in each. This guidance is one of a series of guidances FDA is developing, or has E:\FR\FM\25FEN1.SGM 25FEN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 37 / Monday, February 25, 2013 / Notices developed, to assist applicants with the content and format of the labeling for human prescription drug and biological products. In the Federal Register of January 24, 2006 (71 FR 3998), FDA announced the availability of final guidances on the content and format of the ‘‘Adverse Reactions’’ (http://www. fda.gov/downloads/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/ucm075057.pdf) and ‘‘Clinical Studies’’ (http://www.fda.gov/ downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ ucm075059.pdf) sections of labeling. In the Federal Register of October 19, 2009 (74 FR 53507), FDA announced the availability of final guidance on determining established pharmacologic class for use in the Highlights of Prescribing Information (http:// www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatory Information/Guidances/UCM186607. pdf). In the Federal Register of March 23, 2010 (75 FR 13766), FDA announced the availability of final guidance on the content and format of the ‘‘Dosage and Administration’’ section of labeling (http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatory Information/Guidances/ UCM075066.pdf). In the Federal Register of October 12, 2011 (76 FR 63303), FDA announced the availability of final guidance on the content and format of the ‘‘Warnings and Precautions,’’ ‘‘Contraindications,’’ and ‘‘Boxed Warning’’ sections of labeling (http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatory Information/Guidances/UCM075096. pdf) and in the Federal Register of March 3, 2009 (74 FR 9250), FDA announced the availability of draft guidance on the content and format of the ‘‘Clinical Pharmacology’’ section of labeling (http://www.fda.gov/ downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ UCM109739.pdf). The labeling requirements and these guidances are intended to make information in prescription drug labeling easier for health care practitioners to access, read, and use. On January 24, 2006, FDA announced the availability of draft guidance entitled ‘‘Labeling for Human Prescription Drug and Biological Products—Implementing the New Content and Format Requirements’’ to obtain public comment (71 FR 3998). FDA received a number of comments, most of which sought clarifications and illustrations of the issues discussed in individual sections of the guidance. FDA reviewed all received comments VerDate Mar<15>2010 17:22 Feb 22, 2013 Jkt 229001 carefully during the finalization of the guidance and made clarifying changes based on input from these comments and comments from FDA reviewers with labeling expertise. 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 implementing the PLR content and format requirements for labeling for human prescription drug and biological 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 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. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in §§ 201.56 and 201.57 have been approved under OMB control number 0910–0572. IV. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, http:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm or http:// www.regulations.gov. Dated: February 19, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–04195 Filed 2–22–13; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 12761 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2006–D–0409] (formerly 2006D–0169) Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act; Withdrawal of Guidance AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal. The Food and Drug Administration (FDA or we) is announcing the withdrawal of a guidance entitled ‘‘Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act,’’ dated April 2006, that was announced in the Federal Register on May 2, 2006. The guidance explained FDA’s then current thinking on the labeling of certain uses of lecithin derived from soy under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and was part of FDA’s implementation of the Food Allergen Labeling and Consumer Protection Act (FALCPA). We are taking this action because the policy stated in the guidance regarding FDA’s consideration of the exercise of enforcement discretion no longer reflects our current thinking. DATES: The withdrawal is effective February 25, 2013. FOR FURTHER INFORMATION CONTACT: Steven M. Gendel, Center for Food Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1056. SUPPLEMENTARY INFORMATION: In a notice published in the Federal Register of May 2, 2006 (71 FR 25844), we announced the availability of a guidance entitled ‘‘Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act.’’ The guidance explained that, consistent with the need to establish enforcement priorities, we would consider the exercise of enforcement discretion for a food labeled on or after January 1, 2006, in which lecithin derived from soy is used solely as a component of a release agent and the label for such food does not declare the presence of soy consistent with the requirements of section 403(w) of the FD&C Act (21 U.S.C. 343(w)). In that guidance, the SUMMARY: E:\FR\FM\25FEN1.SGM 25FEN1

Agencies

[Federal Register Volume 78, Number 37 (Monday, February 25, 2013)]
[Notices]
[Pages 12760-12761]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04195]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-D-0153; formerly 2005D-0011]


Guidance for Industry on Labeling for Human Prescription Drug and 
Biological Products--Implementing the Physician Labeling Rule Content 
and Format Requirements; 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 ``Labeling for Human 
Prescription Drug and Biological Products--Implementing the PLR Content 
and Format Requirements.'' This guidance is intended to assist 
applicants in complying with the content and format requirements of 
labeling for human prescription drug and biological products. The 
recommendations in this guidance will help ensure that the labeling is 
clear; useful; informative; and to the extent possible, consistent in 
content and format. It will assist applicants in developing labeling 
for new products, revising existing labeling, and implementing the 
requirements on content and format of labeling for human prescription 
drug and biological products (71 FR 3922), which appeared in the 
Federal Register of January 24, 2006. The rule is commonly referred to 
as the ``Physician Labeling Rule'' (PLR) because it addresses 
prescription drug labeling that is used by prescribers and other health 
care practitioners.

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 or 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. 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 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: Lori Bickel, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6353, Silver Spring, MD 20993-0002, 301-
796-0210; or Stephen Ripley, Center for Biologics Evaluation and 
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Labeling for Human Prescription Drug and Biological 
Products--Implementing the PLR Content and Format Requirements.'' The 
guidance provides recommendations on how to create professional 
labeling consistent with the requirements on content and format of 
labeling for human prescription drug and biological products under 
Sec. Sec.  201.56 and 201.57 (21 CFR 201.56 and 201.57) (71 FR 3922). 
The guidance also provides recommendations on how to organize labeling 
sections and what information should be included in each.
    This guidance is one of a series of guidances FDA is developing, or 
has

[[Page 12761]]

developed, to assist applicants with the content and format of the 
labeling for human prescription drug and biological products. In the 
Federal Register of January 24, 2006 (71 FR 3998), FDA announced the 
availability of final guidances on the content and format of the 
``Adverse Reactions'' (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075057.pdf) and 
``Clinical Studies'' (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075059.pdf) 
sections of labeling. In the Federal Register of October 19, 2009 (74 
FR 53507), FDA announced the availability of final guidance on 
determining established pharmacologic class for use in the Highlights 
of Prescribing Information (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM186607.pdf). In 
the Federal Register of March 23, 2010 (75 FR 13766), FDA announced the 
availability of final guidance on the content and format of the 
``Dosage and Administration'' section of labeling (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075066.pdf). In the Federal Register of October 12, 2011 (76 FR 
63303), FDA announced the availability of final guidance on the content 
and format of the ``Warnings and Precautions,'' ``Contraindications,'' 
and ``Boxed Warning'' sections of labeling (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075096.pdf) and in the Federal Register of March 3, 2009 (74 FR 
9250), FDA announced the availability of draft guidance on the content 
and format of the ``Clinical Pharmacology'' section of labeling (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM109739.pdf). The labeling requirements and these guidances 
are intended to make information in prescription drug labeling easier 
for health care practitioners to access, read, and use.
    On January 24, 2006, FDA announced the availability of draft 
guidance entitled ``Labeling for Human Prescription Drug and Biological 
Products--Implementing the New Content and Format Requirements'' to 
obtain public comment (71 FR 3998). FDA received a number of comments, 
most of which sought clarifications and illustrations of the issues 
discussed in individual sections of the guidance. FDA reviewed all 
received comments carefully during the finalization of the guidance and 
made clarifying changes based on input from these comments and comments 
from FDA reviewers with labeling expertise.
    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 implementing the PLR content and format 
requirements for labeling for human prescription drug and biological 
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 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. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in Sec. Sec.  201.56 and 201.57 have been 
approved under OMB control number 0910-0572.

IV. Electronic Access

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

    Dated: February 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04195 Filed 2-22-13; 8:45 am]
BILLING CODE 4160-01-P