81 FR 87563 - Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products-Content and Format; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 233 (December 5, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 233 (December 5, 2016)
| Page Range | 87563-87565 | |
| FR Document | 2016-29125 |
[Federal Register Volume 81, Number 233 (Monday, December 5, 2016)] [Notices] [Pages 87563-87565] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29125] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0095] Clinical Pharmacology 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 Agency) is announcing the availability of a guidance for industry entitled ``Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products--Content and Format.'' This guidance is one of a series of guidance documents intended to assist applicants in complying with FDA regulations on the content and form at of labeling for human prescription drug and biological products. The guidance describes the recommended information to include in the CLINICAL PHARMACOLOGY section of labeling that pertains to the safe and effective use of human prescription drug and biological products. This guidance finalizes the 2014 revised draft guidance entitled ``Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products--Considerations, Content, and Format.'' [[Page 87564]] DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2009-D-0095 for ``Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products--Content and Format; Guidance for Industry; Availability.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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 20993-0002; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), 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. FOR FURTHER INFORMATION CONTACT: Joseph Grillo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3177, Silver Spring, MD 20993-0002, 301- 796-5008; 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 In the Federal Register of January 24, 2006 (71 FR 3922), FDA published a final rule entitled ``Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products'' to revise the Agency's previous regulations on labeling (effective June 30, 2006). The final rule, commonly referred to as the Physician Labeling Rule (PLR), is designed to make information in prescription drug labeling easier for health care practitioners to access, read, and use, thereby increasing the extent to which health care providers rely on labeling for prescribing decisions. In the Federal Registerof March 3, 2009 (74 FR 9250), FDA announced the availability of a draft guidance on the format and content of the CLINICAL PHARMACOLOGY section of labeling. After considering received comments on the 2009 draft guidance, the Agency announced the availability of a revised draft guidance entitled ``Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products--Considerations, Content, and Format'' in the Federal Register of August 14, 2014 (79 FR 47650). After carefully reviewing received comments on the 2014 revised draft guidance and in light of the Agency's increased regulatory experience implementing the PLR and FDA's labeling and communication initiatives to ensure consistency and clarity, FDA has finalized the guidance. II. Guidance FDA is announcing the availability of a guidance for industry entitled ``Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products--Content and Format'' as one of a series of guidance documents intended to assist applicants in complying with FDA regulations on the content and format of labeling for human prescription drug and biological products. This guidance provides clarity on the information that should be included in section 12 CLINICAL PHARMACOLOGY of the prescription [[Page 87565]] drug labeling under the PLR (21 CFR 201.57(c)(13)) and provides guidance on the inclusion of clinical recommendations based on clinical pharmacology findings in other sections of the labeling. The guidance is also intended to ensure consistency, as appropriate, in labeling of the CLINICAL PHARMACOLOGY section for all prescription drug products approved by FDA. This guidance provides a general framework and set of recommendations that should be adapted to specific drugs and their conditions of use. Not all of the information identified in this guidance for inclusion in the CLINICAL PHARMACOLOGY section of product labeling will be applicable for every drug. For the purposes of this notice, all references to drugs include both human drugs and biological products unless otherwise specified. The guidance outlines the use of subsections, headings, and subheadings to provide organization for the CLINCAL PHARMACOLOGY section in labeling. The guidance also emphasizes the importance of providing variability measures related to pharmacokinetic measures and parameters, pharmacodynamic measures, and other clinical pharmacology study results. In addition to clarifications and edits throughout the guidance on various subsections of section 12, some notable changes from the revised draft guidance include: Addressing whether applicants are expected to revise current approved labeling if reserved sections 12.4 and 12.5 have already been used for other topics, and Providing revised recommendations on the inclusion of pregnancy and lactation information to be consistent with recommendations in FDA's ``Pregnancy and Lactation Labeling Rule'' (https://www.federalregister.gov/documents/2014/12/04/2014-28241/content-and-format-of-labeling-for-human-prescription-drug-and-biological-products-requirements-for) (December 2014) and draft guidance for industry entitled ``Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products--Content and Format'' (http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm425398.pdf) (December 2014). This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on inclusion of clinical pharmacology information in section 12 CLINICAL PHARMACOLOGY of product labeling. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirement of the applicable statutes and regulations. III. The Paperwork Reduction Act of 1995 This 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 201.56 and 201.57 have been approved under OMB control number 0910-0572; the collections of information related to pharmacogenomic data have been approved under OMB control number 0910-0557. 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/Guidances/default.htm, or https://www.regulations.gov. Dated: November 29, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-29125 Filed 12-2-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices 87563
DEPARTMENT OF HEALTH AND Office of Child Support Enforcement expertise in advising the Assistant
HUMAN SERVICES (KF) Secretary, ACF, in the formulation of
Office of Community Services (KG) policy views, positions, and
Administration for Children and Office of Family Assistance (KH) implementation strategies related to
Families Office of Regional Operations (KJ) American Indians, Alaska Natives, and
Office of Planning, Research and Native Americans as delineated in the
Statement of Organization, Functions, Evaluation (KM) Native American Programs Act (NAPA).
and Delegations of Authority Office of Communications (KN) The incumbent will also serve as a key
AGENCY: Administration for Children Office of the Deputy Assistant Secretary liaison and representative to all ACF
and Families, HHS. for Administration (KP) program and staff offices on behalf of
ACTION: Notice.
Office of the Chief Information Officer the Assistant Secretary related to tribal
(KQ) and Native American affairs. The
SUMMARY: Statement of Organizations, Office of Refugee Resettlement (KR) Deputy Assistant Secretary for Policy
Functions, and Delegations of Office of Legislative Affairs and Budget has responsibility for cross-program
Authority. The Administration for (KT) coordination of ACF initiatives,
Children and Families (ACF) has added Office of Head Start (KU) including efforts to promote
the title Deputy Assistant Secretary for Office of Child Care (KV) interoperability and program
Native American Affairs to Office of Human Services Emergency integration.
Commissioner, Administration for Preparedness and Response (KW)*** Dated: November 29, 2016.
Native Americans position. II. Under Chapter KA, Office of the Mark H. Greenberg,
FOR FURTHER INFORMATION CONTACT: Jeff Assistant Secretary for Children and
Acting Assistant Secretary for Children and
Hild, ACF Chief of Staff, 330 C Street Families, delete KA.20 Functions, Families.
SW., Washington, DC 20201, (202) 401– Paragraph A in its entirety and replace
[FR Doc. 2016–29112 Filed 12–2–16; 8:45 am]
5180. with the following:
BILLING CODE 4184–34–P
Part K of the Statement of KA.20 Functions. A. Office of the
Organization, Functions, and Assistant Secretary for Children and
Delegations of Authority of the Families: The Office of the Assistant
DEPARTMENT OF HEALTH AND
Department of Health and Human Secretary for Children and Families is
HUMAN SERVICES
Services (HHS), Administration for responsible to the Secretary for carrying
Children and Families (ACF) is being out ACF’s mission and providing Food and Drug Administration
amended at Chapter K, Administration executive supervision of the major
for Children and Families, as last components of ACF. These
amended at 81 FR 49223 as follows: responsibilities include providing [Docket No. FDA–2009–D–0095]
I. Under Chapter K, ACF, delete K.10 executive leadership and direction to
Clinical Pharmacology Section of
Organization in its entirety and replace plan and coordinate ACF program
Labeling for Human Prescription Drug
with the following: activities to ensure their effectiveness;
and Biological Products—Content and
K.10 Organization. The approving instructions, policies,
Format; Guidance for Industry;
Administration for Children and publications, and grant awards issued
Availability
Families (ACF) is a principal operating by ACF; and representing ACF in
division of the Department of Health relationships with governmental and AGENCY: Food and Drug Administration,
and Human Services (HHS). The nongovernmental organizations. The HHS.
Administration for Children and Principal Deputy Assistant Secretary
Families is headed by the Assistant serves as an alter ego to the Assistant ACTION: Notice.
Secretary for Children and Families, Secretary for Children and Families on
who reports directly to the Secretary. program matters and acts in the absence SUMMARY: The Food and Drug
The Assistant Secretary also serves as of the Assistant Secretary for Children Administration (FDA or Agency) is
the Director of Child Support and Families. The Chief of Staff advises announcing the availability of a
Enforcement. In addition to the the Assistant Secretary for Children and guidance for industry entitled ‘‘Clinical
Assistant Secretary, the Administration Families and provides executive Pharmacology Section of Labeling for
consists of the Principal Deputy leadership and direction to the Human Prescription Drug and Biological
Assistant Secretary; the Chief of Staff; operations of ACF. The Deputy Products—Content and Format.’’ This
the Deputy Assistant Secretary for Assistant Secretary for External Affairs guidance is one of a series of guidance
Administration; the Deputy Assistant provides executive leadership and documents intended to assist applicants
Secretary for Policy; the Deputy direction to the Offices of Regional in complying with FDA regulations on
Assistant Secretary for Early Childhood Operations and Communications. The the content and form at of labeling for
Development; the Deputy Assistant Deputy Assistant Secretary for Early human prescription drug and biological
Secretary for Native American Affairs Childhood Development serves as a key products. The guidance describes the
and Commissioner, Administration for liaison and representative to the recommended information to include in
Native Americans; the Deputy Assistant Department for early childhood the CLINICAL PHARMACOLOGY
Secretary for External Affairs; and Staff development on behalf of the Assistant section of labeling that pertains to the
and Program Offices. ACF is organized Secretary, ACF, and to other agencies safe and effective use of human
sradovich on DSK3GMQ082PROD with NOTICES
as follows: across the government on behalf of the prescription drug and biological
Office of the Assistant Secretary for Department. The Deputy Assistant products. This guidance finalizes the
Children and Families (KA) Secretary for Native American Affairs 2014 revised draft guidance entitled
Administration on Children, Youth and and Commissioner of the ‘‘Clinical Pharmacology Labeling for
Families (KB) Administration for Native Americans is Human Prescription Drug and Biological
Administration for Native Americans responsible for handling a variety of Products—Considerations, Content, and
(KE) assignments requiring knowledge and Format.’’
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![Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices 87565
drug labeling under the PLR (21 CFR product labeling. It does not establish DATES: Submit either electronic or
201.57(c)(13)) and provides guidance on any rights for any person and is not written comments on Agency guidances
the inclusion of clinical binding on FDA or the public. You can at any time.
recommendations based on clinical use an alternative approach if it satisfies ADDRESSES: You may submit comments
pharmacology findings in other sections the requirement of the applicable as follows:
of the labeling. The guidance is also statutes and regulations.
intended to ensure consistency, as Electronic Submissions
appropriate, in labeling of the III. The Paperwork Reduction Act of Submit electronic comments in the
CLINICAL PHARMACOLOGY section 1995 following way:
for all prescription drug products This guidance refers to previously • Federal eRulemaking Portal: http://
approved by FDA. approved collections of information that www.regulations.gov. Follow the
This guidance provides a general are subject to review by the Office of instructions for submitting comments.
framework and set of recommendations Management and Budget (OMB) under Comments submitted electronically,
that should be adapted to specific drugs the Paperwork Reduction Act of 1995 including attachments, to http://
and their conditions of use. Not all of (44 U.S.C. 3501–3520). The collections www.regulations.gov will be posted to
the information identified in this of information in 21 CFR 201.56 and the docket unchanged. Because your
guidance for inclusion in the CLINICAL 201.57 have been approved under OMB comment will be made public, you are
PHARMACOLOGY section of product control number 0910–0572; the solely responsible for ensuring that your
labeling will be applicable for every collections of information related to comment does not include any
drug. For the purposes of this notice, all pharmacogenomic data have been confidential information that you or a
references to drugs include both human approved under OMB control number third party may not wish to be posted,
drugs and biological products unless 0910–0557. such as medical information, your or
otherwise specified. anyone else’s Social Security number, or
The guidance outlines the use of IV. Electronic Access confidential business information, such
subsections, headings, and subheadings Persons with access to the Internet as a manufacturing process. Please note
to provide organization for the may obtain the document at either that if you include your name, contact
CLINCAL PHARMACOLOGY section in http://www.fda.gov/Drugs/Guidance information, or other information that
labeling. The guidance also emphasizes ComplianceRegulatoryInformation/ identifies you in the body of your
the importance of providing variability Guidances/default.htm, http:// comments, that information will be
measures related to pharmacokinetic www.fda.gov/BiologicsBloodVaccines/ posted on http://www.regulations.gov.
measures and parameters, GuidanceComplianceRegulatory • If you want to submit a comment
pharmacodynamic measures, and other Information/Guidances/default.htm, or with confidential information that you
clinical pharmacology study results. https://www.regulations.gov. do not wish to be made available to the
In addition to clarifications and edits public, submit the comment as a
throughout the guidance on various Dated: November 29, 2016.
written/paper submission and in the
subsections of section 12, some notable Leslie Kux,
manner detailed (see ‘‘Written/Paper
changes from the revised draft guidance Associate Commissioner for Policy.
Submissions’’ and ‘‘Instructions’’).
include: [FR Doc. 2016–29125 Filed 12–2–16; 8:45 am]
• Addressing whether applicants are BILLING CODE 4164–01–P
Written/Paper Submissions
expected to revise current approved Submit written/paper submissions as
labeling if reserved sections 12.4 and follows:
12.5 have already been used for other DEPARTMENT OF HEALTH AND • Mail/Hand delivery/Courier (for
topics, and HUMAN SERVICES written/paper submissions): Division of
• Providing revised recommendations Dockets Management (HFA–305), Food
on the inclusion of pregnancy and Food and Drug Administration and Drug Administration, 5630 Fishers
lactation information to be consistent Lane, Rm. 1061, Rockville, MD 20852.
[Docket No. FDA–2009–D–0600]
with recommendations in FDA’s • For written/paper comments
‘‘Pregnancy and Lactation Labeling Health Document Submission submitted to the Division of Dockets
Rule’’ (https://www.federalregister.gov/ Requirements for Tobacco Products; Management, FDA will post your
documents/2014/12/04/2014-28241/ Guidance for Industry; Availability comment, as well as any attachments,
content-and-format-of-labeling-for- except for information submitted,
human-prescription-drug-and- AGENCY: Food and Drug Administration, marked and identified, as confidential,
biological-products-requirements-for) HHS. if submitted as detailed in
(December 2014) and draft guidance for ACTION: Notice of availability. ‘‘Instructions.’’
industry entitled ‘‘Pregnancy, Lactation, Instructions: All submissions received
and Reproductive Potential: Labeling for SUMMARY: The Food and Drug must include the Docket No. FDA–
Human Prescription Drug and Biological Administration (FDA or we) is 2009–D–0600 for ‘‘Health Document
Products—Content and Format’’ (http:// announcing the availability of a revised Submission Requirements for Tobacco
www.fda.gov/downloads/drugs/ guidance for industry entitled ‘‘Health Products.’’ Received comments will be
guidancecomplianceregulatory Document Submission Requirements for placed in the docket and, except for
information/guidances/ucm425398.pdf) Tobacco Products.’’ The guidance those submitted as ‘‘Confidential
provides information to assist persons
sradovich on DSK3GMQ082PROD with NOTICES
(December 2014). Submissions,’’ publicly viewable at
This guidance is being issued making health document submissions to http://www.regulations.gov or at the
consistent with FDA’s good guidance FDA as required by the Family Smoking Division of Dockets Management
practices regulation (21 CFR 10.115). Prevention and Tobacco Control Act. between 9 a.m. and 4 p.m., Monday
The guidance represents the current We received several comments to the through Friday.
thinking of FDA on inclusion of clinical draft guidance, and those comments • Confidential Submissions—To
pharmacology information in section 12 were considered as the guidance was submit a comment with confidential
CLINICAL PHARMACOLOGY of finalized. information that you do not wish to be
VerDate Sep<11>2014 19:12 Dec 02, 2016 Jkt 241001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\05DEN1.SGM 05DEN1](https://thefederalregister.org/doc/81_FR_87796/page/3.svg)
Document Created: 2016-12-03 00:25:47
Document Modified: 2016-12-03 00:25:47
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Joseph Grillo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3177, Silver Spring, MD 20993-0002, 301- 796-5008; 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. | |
| FR Citation | 81 FR 87563 |
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