Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products-Content and Format; Guidance for Industry; Availability, 73322-73323 [2014-28888]

Download as PDF 73322 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices presiding officer may omit a participant’s appearance. The presiding officer and other participants will use the collected information in a hearing to identify specific interests to be presented. This preliminary information serves to expedite the prehearing conference and commits participation. The respondents are individuals or households, State or local governments, not-for-profit institutions and businesses, or other for-profit groups and institutions. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents 21 CFR Section 10.30—Citizen Petition ........................................................ 10.33—Administrative reconsideration of action ................. 10.35—Administrative Stay of Action .................................. 10.85—Advisory Opinions ................................................... 12.22—Filing Objections and Requests for a Hearing on a Regulation or Order .......................................................... 12.45—Notice of Participation ............................................. Average burden per response Total annual responses 207 4 5 4 1 1 1 1 207 4 5 4 24 10 10 16 4,968 40 50 64 3 4 1 1 3 4 20 3 60 12 Total .............................................................................. 1 There Dated: December 4, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–28825 Filed 12–9–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–1067] Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products—Content and Format; Guidance for Industry; Availability Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled ‘‘Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.’’ The recommendations in this guidance are intended to assist applicants in developing the ‘‘Patient Counseling Information’’ section of labeling and to help ensure that this section of labeling is clear, useful, informative, and to the extent possible, consistent in content and format. This guidance finalizes the draft guidance issued on September 18, 2013. SUMMARY: mstockstill on DSK4VPTVN1PROD with NOTICES 5,194 are no capital costs or operating and maintenance costs associated with this collection of information. The burden estimates for this collection of information are based on Agency records and experience over the past 3 years. AGENCY: Total hours VerDate Sep<11>2014 17:48 Dec 09, 2014 Jkt 235001 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, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 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: Jonas Santiago, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6348, Silver Spring, MD 20993–0002, 301– 796–5346; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: DATES: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Patient PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Counseling Information Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.’’ This guidance is intended to assist applicants in developing the Patient Counseling Information section of labeling required under 21 CFR 201.57(c)(18). Recommendations include the following: (1) How to decide what topics to include in the section, (2) how to present information within the section, and (3) how to format and organize section contents. This guidance is one of a series of guidances FDA is developing, or has developed, to assist applicants with the content and format of labeling for human prescription drug and biological products. In the Federal Register of January 24, 2006 (71 FR 3922), FDA published a final rule on labeling for human prescription drug and biological products. The final rule and additional guidances can be accessed at https:// www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/ LawsActsandRules/ucm084159.htm. 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. This guidance finalizes the draft guidance issued on September 18, 2013 (78 FR 57394). FDA reviewed all received comments carefully during the finalization of the guidance. Other than clarifying edits, no changes of significance were made to the final version of the guidance. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s E:\FR\FM\10DEN1.SGM 10DEN1 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices current thinking on the content and format of the Patient Counseling Information section of 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 https://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 https:// www.regulations.gov. III. The 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 21 CFR 201.56 and 201.57 have been approved under OMB control number 0910–0572. IV. Electronic Access mstockstill on DSK4VPTVN1PROD with NOTICES Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, https://www.fda.gov/ BiologicsBloodVaccines/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, or https:// www.regulations.gov. Dated: December 4, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–28888 Filed 12–9–14; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:48 Dec 09, 2014 Jkt 235001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0588] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI #214) entitled ‘‘Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data’’ (VICH GL35). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide recommended standards to construct a single Adverse Event Report (AER) electronic message to transmit VICH GL42 contents to all member regions and Product Problem Reports (PPR) to FDA for veterinary medicinal products. Please note that VICH GL42 has been harmonized in GFI #188, ‘‘Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine.’’ DATES: Submit either electronic or written comments on Agency guidance at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your request. 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 on the guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Margarita Brown, Center for Veterinary Medicine (HFV–240), Food and Drug SUMMARY: PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 73323 Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–9048, CVMAESupport@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. FDA has actively participated in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use for several years to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives. The VICH Steering Committee is composed of member representatives from the European Commission, European Medicines Evaluation Agency, European Federation of Animal Health, Committee on Veterinary Medicinal Products, FDA, U.S. Department of Agriculture, the Animal Health Institute, the Japanese Veterinary Pharmaceutical Association, the Japanese Association of Veterinary Biologics, and the Japanese Ministry of Agriculture, Forestry, and Fisheries. Six observers are eligible to participate in the VICH Steering Committee: One representative from the government of Australia/New Zealand, one representative from the industry in Australia/New Zealand, one representative from the government of Canada, one representative from the industry of Canada, one representative from the government of South Africa, and one representative from the industry of South Africa. The VICH Secretariat, which coordinates the preparation of documentation, is provided by the International E:\FR\FM\10DEN1.SGM 10DEN1

Agencies

[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Notices]
[Pages 73322-73323]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28888]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1067]


Patient Counseling Information Section of Labeling for Human 
Prescription Drug and Biological Products--Content and Format; Guidance 
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the availability of a guidance for industry entitled 
``Patient Counseling Information Section of Labeling for Human 
Prescription Drug and Biological Products--Content and Format.'' The 
recommendations in this guidance are intended to assist applicants in 
developing the ``Patient Counseling Information'' section of labeling 
and to help ensure that this section of labeling is clear, useful, 
informative, and to the extent possible, consistent in content and 
format. This guidance finalizes the draft guidance issued on September 
18, 2013.

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, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993, or the Office 
of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, 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: Jonas Santiago, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6348, Silver Spring, MD 20993-0002, 301-
796-5346; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Patient Counseling Information Section of Labeling for Human 
Prescription Drug and Biological Products--Content and Format.'' This 
guidance is intended to assist applicants in developing the Patient 
Counseling Information section of labeling required under 21 CFR 
201.57(c)(18). Recommendations include the following: (1) How to decide 
what topics to include in the section, (2) how to present information 
within the section, and (3) how to format and organize section 
contents.
    This guidance is one of a series of guidances FDA is developing, or 
has developed, to assist applicants with the content and format of 
labeling for human prescription drug and biological products. In the 
Federal Register of January 24, 2006 (71 FR 3922), FDA published a 
final rule on labeling for human prescription drug and biological 
products. The final rule and additional guidances can be accessed at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm084159.htm. 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.
    This guidance finalizes the draft guidance issued on September 18, 
2013 (78 FR 57394). FDA reviewed all received comments carefully during 
the finalization of the guidance. Other than clarifying edits, no 
changes of significance were made to the final version of the guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's

[[Page 73323]]

current thinking on the content and format of the Patient Counseling 
Information section of 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 https://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 https://www.regulations.gov.

III. The 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 21 CFR 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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: December 4, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28888 Filed 12-9-14; 8:45 am]
BILLING CODE 4164-01-P
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