Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability, 60917-60918 [2015-25622]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices provided additional recommendations for describing individual trials and providing results of efficacy analyses. This guidance supersedes section II.G., Integrated Summary of Effectiveness Data, of the Clin-Stat guidance to reflect FDA’s current thinking regarding the format and content of the ISE to provide a truly integrated analysis, rather than a summary of efficacy results from individual clinical trials, and to satisfy FDA regulatory requirements. This guidance also incorporates the conceptual framework of section 2.7.3, Summary of Clinical Efficacy, from ICH M4E. Although there are no corresponding regulations requiring an ISE for BLA submissions, applicants are encouraged to provide these analyses. The focus of the ISE is not on the detailed results of individual studies, which are described in individual study reports, but a comprehensive, detailed, integrated analysis that goes beyond individual study results to examine all sources of information concerning effectiveness to provide further insight into the efficacy of the study drug. Integrated analyses included in an ISE generally fall into two broad categories: (1) Comparing the individual studies to better understand the overall results; and (2) using the greater power of pooled analyses to gain insight into the nature of the drug’s effectiveness in demographic (e.g., age, sex, race, and ethnicity) and other subpopulations, dose-response, and onset and duration of effect, among others. A draft of this guidance was published for comment in the Federal Register on August 28, 2008 (73 FR 50825). Comments received on the draft guidance have been considered and the guidance has been revised as follows: (1) Clarification on the difference between the document included in Module 2, section 2.7.3, Summary of Clinical Efficacy, from ICH M4E, and the ISE has been provided; (2) the definition of integrated analyses has been revised and the components that constitute an integrated analyses have been clarified; (3) pooled analyses has been defined; and (4) the recommendations for when it is appropriate to pool data has been included. 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 preparing an ISE. 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 requirements VerDate Sep<11>2014 16:41 Oct 07, 2015 Jkt 238001 60917 of the applicable statutes and regulations. ADDRESSES: II. 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 part 314 have been approved under OMB control number 0910–0001. The collections of information for submission of data in a BLA under 21 CFR 601.2 have been approved under OMB control number 0910–0338. 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’’). III. Electronic Access Persons with access to the Internet may obtain the guidance at https://www. fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, https://www.fda.gov/ BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, or https:// www.regulations.gov. Dated: October 2, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–25630 Filed 10–7–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–2138] Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled ‘‘Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.’’ Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), an outsourcing facility must submit adverse event reports to FDA. This guidance explains FDA’s current thinking on adverse event reporting for these outsourcing facilities. DATES: Submit either electronic or written comments on Agency guidances at any time. SUMMARY: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 You may submit comments as follows: 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– 2014–D–2138 for Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; 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 E:\FR\FM\08OCN1.SGM 08OCN1 mstockstill on DSK4VPTVN1PROD with NOTICES 60918 Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices 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: https://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 the 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. 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: Sara Rothman, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–3110. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a final guidance for industry entitled VerDate Sep<11>2014 16:41 Oct 07, 2015 Jkt 238001 ‘‘Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.’’ On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA) into law (Pub. L. 113–54). The DQSA added a new section, 503B, to the FD&C Act (21 U.S.C. 353b). Under section 503B(b), a compounder can register as an outsourcing facility with FDA. Section 503B(d)(4) of the FD&C Act defines an outsourcing facility, in part, as a facility that complies with all of the requirements of section 503B, including registering with FDA as an outsourcing facility and paying associated fees. If the conditions outlined in section 503B(a) of the FD&C Act are satisfied, a drug compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility is exempt from certain sections of the FD&C Act, including section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use) and section 505 (21 U.S.C. 355) (concerning the approval of human drug products under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)). Drugs compounded in outsourcing facilities are not exempt from the requirements of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice for drugs). Under section 503B(b)(5), an outsourcing facility must submit adverse event reports to FDA in accordance with the content and format requirements established through guidance or regulation under 21 CFR 310.305 (or any successor regulations). This guidance explains how FDA intends to implement § 310.305 with respect to outsourcing facilities. In the Federal Register of February 19, 2015 (80 FR 8872), FDA issued a notice announcing the availability of the draft version of this guidance. The comment period on the draft guidance ended on May 20, 2015. FDA received seven comments on the draft guidance. In response to received comments or on its own initiative, FDA made several changes to clarify particular points and to provide updated information. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents FDA’s current thinking on this topic. It does not create any rights for any person and is not binding on FDA or the public. An alternative approach can be used if such approach satisfies the requirements of the applicable statutes and regulations. PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 II. Paperwork Reduction Act This guidance contains collections of information that are subject to review by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information have been approved under OMB control number 0910–0800. III. Electronic Access Persons with access to the Internet may obtain the guidance at either https://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. Dated: October 2, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–25622 Filed 10–7–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0248] Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by November 9, 2015. ADDRESSES: You may submit comments as follows: SUMMARY: 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 E:\FR\FM\08OCN1.SGM 08OCN1

Agencies

[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60917-60918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25622]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-2138]

Adverse Event Reporting for Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and Cosmetic Act; 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 final guidance for industry entitled
``Adverse Event Reporting for Outsourcing Facilities Under Section 503B
of the Federal Food, Drug, and Cosmetic Act.'' Under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act), an outsourcing facility must
submit adverse event reports to FDA. This guidance explains FDA's
current thinking on adverse event reporting for these outsourcing
facilities.

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-2014-D-2138 for Adverse Event Reporting for Outsourcing Facilities
Under Section 503B of the Federal Food, Drug, and Cosmetic Act;
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

[[Page 60918]]

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: https://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 the 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. 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: Sara Rothman, Office of Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3110.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a final guidance for industry
entitled ``Adverse Event Reporting for Outsourcing Facilities Under
Section 503B of the Federal Food, Drug, and Cosmetic Act.'' On November
27, 2013, President Obama signed the Drug Quality and Security Act
(DQSA) into law (Pub. L. 113-54). The DQSA added a new section, 503B,
to the FD&C Act (21 U.S.C. 353b). Under section 503B(b), a compounder
can register as an outsourcing facility with FDA. Section 503B(d)(4) of
the FD&C Act defines an outsourcing facility, in part, as a facility
that complies with all of the requirements of section 503B, including
registering with FDA as an outsourcing facility and paying associated
fees. If the conditions outlined in section 503B(a) of the FD&C Act are
satisfied, a drug compounded by or under the direct supervision of a
licensed pharmacist in an outsourcing facility is exempt from certain
sections of the FD&C Act, including section 502(f)(1) (21 U.S.C.
352(f)(1)) (concerning the labeling of drugs with adequate directions
for use) and section 505 (21 U.S.C. 355) (concerning the approval of
human drug products under new drug applications (NDAs) or abbreviated
new drug applications (ANDAs)). Drugs compounded in outsourcing
facilities are not exempt from the requirements of section 501(a)(2)(B)
of the FD&C Act (21 U.S.C. 351(a)(2)(B)) (concerning current good
manufacturing practice for drugs).
Under section 503B(b)(5), an outsourcing facility must submit
adverse event reports to FDA in accordance with the content and format
requirements established through guidance or regulation under 21 CFR
310.305 (or any successor regulations). This guidance explains how FDA
intends to implement Sec. 310.305 with respect to outsourcing
facilities.
In the Federal Register of February 19, 2015 (80 FR 8872), FDA
issued a notice announcing the availability of the draft version of
this guidance. The comment period on the draft guidance ended on May
20, 2015. FDA received seven comments on the draft guidance.
In response to received comments or on its own initiative, FDA made
several changes to clarify particular points and to provide updated
information.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA's
current thinking on this topic. It does not create any rights for any
person and is not binding on FDA or the public. An alternative approach
can be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act

This guidance contains collections of information that are subject
to review by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information have been approved under OMB control number 0910-0800.

III. Electronic Access

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

Dated: October 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25622 Filed 10-7-15; 8:45 am]
BILLING CODE 4164-01-P

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