80_FR_61112 80 FR 60917 - Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability

80 FR 60917 - Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 195 (October 8, 2015)

Page Range60917-60918
FR Document2015-25622

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.

Federal Register, Volume 80 Issue 195 (Thursday, October 8, 2015) 
[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60917-60918]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-25622]


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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.

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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: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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 http://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 http://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 http://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 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://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

Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices 60917 provided additional recommendations of the applicable statutes and ADDRESSES: You may submit comments for describing individual trials and regulations. as follows: providing results of efficacy analyses. II. The Paperwork Reduction Act of Electronic Submissions This guidance supersedes section 1995 II.G., Integrated Summary of Submit electronic comments in the Effectiveness Data, of the Clin-Stat This guidance refers to previously following way: guidance to reflect FDA’s current approved collections of information that • Federal eRulemaking Portal: http:// thinking regarding the format and are subject to review by the Office of www.regulations.gov. Follow the content of the ISE to provide a truly Management and Budget (OMB) under instructions for submitting comments. integrated analysis, rather than a the Paperwork Reduction Act of 1995 Comments submitted electronically, summary of efficacy results from (44 U.S.C. 3501–3520). The collections including attachments, to http:// individual clinical trials, and to satisfy of information in 21 CFR part 314 have www.regulations.gov will be posted to FDA regulatory requirements. This been approved under OMB control the docket unchanged. Because your guidance also incorporates the number 0910–0001. The collections of comment will be made public, you are conceptual framework of section 2.7.3, information for submission of data in a solely responsible for ensuring that your Summary of Clinical Efficacy, from ICH BLA under 21 CFR 601.2 have been comment does not include any M4E. Although there are no approved under OMB control number confidential information that you or a corresponding regulations requiring an 0910–0338. third party may not wish to be posted, ISE for BLA submissions, applicants are III. Electronic Access such as medical information, your or encouraged to provide these analyses. anyone else’s Social Security number, or Persons with access to the Internet confidential business information, such The focus of the ISE is not on the may obtain the guidance at http://www. detailed results of individual studies, as a manufacturing process. Please note fda.gov/Drugs/GuidanceCompliance that if you include your name, contact which are described in individual study RegulatoryInformation/Guidances/ reports, but a comprehensive, detailed, information, or other information that default.htm, http://www.fda.gov/ identifies you in the body of your integrated analysis that goes beyond BiologicsBloodVaccines/Guidance individual study results to examine all comments, that information will be ComplianceRegulatoryInformation/ posted on http://www.regulations.gov. sources of information concerning Guidances/default.htm, or http:// effectiveness to provide further insight • If you want to submit a comment www.regulations.gov. with confidential information that you into the efficacy of the study drug. Integrated analyses included in an ISE Dated: October 2, 2015. do not wish to be made available to the generally fall into two broad categories: Leslie Kux, public, submit the comment as a (1) Comparing the individual studies to Associate Commissioner for Policy. written/paper submission and in the better understand the overall results; [FR Doc. 2015–25630 Filed 10–7–15; 8:45 am] manner detailed (see ‘‘Written/Paper and (2) using the greater power of BILLING CODE 4164–01–P Submissions’’ and ‘‘Instructions’’). pooled analyses to gain insight into the Written/Paper Submissions nature of the drug’s effectiveness in Submit written/paper submissions as demographic (e.g., age, sex, race, and DEPARTMENT OF HEALTH AND HUMAN SERVICES follows: ethnicity) and other subpopulations, • Mail/Hand delivery/Courier (for dose-response, and onset and duration written/paper submissions): Division of Food and Drug Administration of effect, among others. Dockets Management (HFA–305), Food A draft of this guidance was [Docket No. FDA–2014–D–2138] and Drug Administration, 5630 Fishers published for comment in the Federal Lane, Rm. 1061, Rockville, MD 20852. Adverse Event Reporting for Register on August 28, 2008 (73 FR • For written/paper comments 50825). Comments received on the draft Outsourcing Facilities Under Section submitted to the Division of Dockets guidance have been considered and the 503B of the Federal Food, Drug, and Management, FDA will post your guidance has been revised as follows: Cosmetic Act; Guidance for Industry; comment, as well as any attachments, (1) Clarification on the difference Availability except for information submitted, between the document included in AGENCY: Food and Drug Administration, marked and identified, as confidential, Module 2, section 2.7.3, Summary of HHS. if submitted as detailed in Clinical Efficacy, from ICH M4E, and ACTION: Notice. ‘‘Instructions.’’ the ISE has been provided; (2) the Instructions: All submissions received definition of integrated analyses has SUMMARY: The Food and Drug must include the Docket No. FDA– been revised and the components that Administration (FDA or the Agency) is 2014–D–2138 for Adverse Event constitute an integrated analyses have announcing the availability of a final Reporting for Outsourcing Facilities been clarified; (3) pooled analyses has guidance for industry entitled ‘‘Adverse Under Section 503B of the Federal been defined; and (4) the Event Reporting for Outsourcing Food, Drug, and Cosmetic Act; recommendations for when it is Facilities Under Section 503B of the Guidance for Industry; Availability. appropriate to pool data has been Federal Food, Drug, and Cosmetic Act.’’ Received comments will be placed in included. Under the Federal Food, Drug, and the docket and, except for those This guidance is being issued Cosmetic Act (the FD&C Act), an submitted as ‘‘Confidential outsourcing facility must submit mstockstill on DSK4VPTVN1PROD with NOTICES consistent with FDA’s good guidance Submissions,’’ publicly viewable at practices regulation (21 CFR 10.115). adverse event reports to FDA. This http://www.regulations.gov or at the The guidance represents the current guidance explains FDA’s current Division of Dockets Management thinking of FDA on preparing an ISE. It thinking on adverse event reporting for between 9 a.m. and 4 p.m., Monday does not establish any rights for any these outsourcing facilities. through Friday. person and is not binding on FDA or the DATES: Submit either electronic or • Confidential Submissions—To public. You can use an alternative written comments on Agency guidances submit a comment with confidential approach if it satisfies the requirements at any time. information that you do not wish to be VerDate Sep<11>2014 16:41 Oct 07, 2015 Jkt 238001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\08OCN1.SGM 08OCN1

60918 Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices made publicly available, submit your ‘‘Adverse Event Reporting for II. Paperwork Reduction Act comments only as a written/paper Outsourcing Facilities Under Section This guidance contains collections of submission. You should submit two 503B of the Federal Food, Drug, and information that are subject to review by copies total. One copy will include the Cosmetic Act.’’ On November 27, 2013, the Office of Management and Budget information you claim to be confidential President Obama signed the Drug under the Paperwork Reduction Act of with a heading or cover note that states Quality and Security Act (DQSA) into 1995 (44 U.S.C. 3501–3520). The ‘‘THIS DOCUMENT CONTAINS law (Pub. L. 113–54). The DQSA added collections of information have been CONFIDENTIAL INFORMATION’’. The a new section, 503B, to the FD&C Act approved under OMB control number Agency will review this copy, including (21 U.S.C. 353b). Under section 503B(b), 0910–0800. the claimed confidential information, in a compounder can register as an its consideration of comments. The outsourcing facility with FDA. Section III. Electronic Access second copy, which will have the 503B(d)(4) of the FD&C Act defines an Persons with access to the Internet claimed confidential information outsourcing facility, in part, as a facility may obtain the guidance at either redacted/blacked out, will be available that complies with all of the http://www.fda.gov/Drugs/ for public viewing and posted on requirements of section 503B, including GuidanceCompliance http://www.regulations.gov. Submit registering with FDA as an outsourcing RegulatoryInformation/Guidances/ both copies to the Division of Dockets facility and paying associated fees. If the default.htm or http:// Management. If you do not wish your conditions outlined in section 503B(a) www.regulations.gov. name and contact information to be of the FD&C Act are satisfied, a drug Dated: October 2, 2015. made publicly available, you can compounded by or under the direct Leslie Kux, provide this information on the cover supervision of a licensed pharmacist in sheet and not in the body of your an outsourcing facility is exempt from Associate Commissioner for Policy. comments and you must identify this certain sections of the FD&C Act, [FR Doc. 2015–25622 Filed 10–7–15; 8:45 am] information as ‘‘confidential.’’ Any including section 502(f)(1) (21 U.S.C. BILLING CODE 4164–01–P information marked as ‘‘confidential’’ 352(f)(1)) (concerning the labeling of will not be disclosed except in drugs with adequate directions for use) accordance with 21 CFR 10.20 and other and section 505 (21 U.S.C. 355) DEPARTMENT OF HEALTH AND applicable disclosure law. For more (concerning the approval of human drug HUMAN SERVICES information about FDA’s posting of products under new drug applications Food and Drug Administration comments to public dockets, see 80 FR (NDAs) or abbreviated new drug 56469, September 18, 2015, or access applications (ANDAs)). Drugs [Docket No. FDA–2012–N–0248] the information at: http://www.fda.gov/ compounded in outsourcing facilities regulatoryinformation/dockets/ are not exempt from the requirements of Agency Information Collection default.htm. section 501(a)(2)(B) of the FD&C Act (21 Activities; Proposed Collection; Docket: For access to the docket to U.S.C. 351(a)(2)(B)) (concerning current Submission for Office of Management read background documents or the good manufacturing practice for drugs). and Budget Review; Guidance for electronic and written/paper comments Industry on Formal Dispute Under section 503B(b)(5), an received, go to http:// Resolution; Appeals Above the outsourcing facility must submit www.regulations.gov and insert the Division Level adverse event reports to FDA in docket number, found in brackets in the accordance with the content and format AGENCY: Food and Drug Administration, heading of this document, into the requirements established through HHS. ‘‘Search’’ box and follow the prompts guidance or regulation under 21 CFR ACTION: Notice. and/or go to the Division of Dockets 310.305 (or any successor regulations). Management, 5630 Fishers Lane, Rm. This guidance explains how FDA SUMMARY: The Food and Drug 1061, Rockville, MD 20852. intends to implement § 310.305 with Administration (FDA) is announcing Submit written requests for single respect to outsourcing facilities. that a proposed collection of copies of the guidance to the Division of information has been submitted to the Drug Information, Center for Drug In the Federal Register of February Office of Management and Budget Evaluation and Research, Food and 19, 2015 (80 FR 8872), FDA issued a (OMB) for review and clearance under Drug Administration, 10001 New notice announcing the availability of the the Paperwork Reduction Act of 1995. Hampshire Ave., Hillandale Building, draft version of this guidance. The comment period on the draft guidance DATES: Fax written comments on the 4th Floor, Silver Spring, MD 20993. collection of information by November Send one self-addressed adhesive label ended on May 20, 2015. FDA received seven comments on the draft guidance. 9, 2015. to assist that office in processing your ADDRESSES: You may submit comments requests. See the SUPPLEMENTARY In response to received comments or as follows: INFORMATION section for electronic on its own initiative, FDA made several access to the guidance document. changes to clarify particular points and Electronic Submissions FOR FURTHER INFORMATION CONTACT: Sara to provide updated information. Submit electronic comments in the Rothman, Office of Compliance, Center This guidance is being issued following way: for Drug Evaluation and Research, Food consistent with FDA’s good guidance • Federal eRulemaking Portal: http:// and Drug Administration, 10903 New mstockstill on DSK4VPTVN1PROD with NOTICES practices regulation (21 CFR 10.115). www.regulations.gov. Follow the Hampshire Ave., Silver Spring, MD The guidance represents FDA’s current instructions for submitting comments. 20993–0002, 301–796–3110. thinking on this topic. It does not create Comments submitted electronically, SUPPLEMENTARY INFORMATION: any rights for any person and is not including attachments, to http:// binding on FDA or the public. An www.regulations.gov will be posted to I. Background alternative approach can be used if such the docket unchanged. Because your FDA is announcing the availability of approach satisfies the requirements of comment will be made public, you are a final guidance for industry entitled the applicable statutes and regulations. solely responsible for ensuring that your VerDate Sep<11>2014 16:41 Oct 07, 2015 Jkt 238001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\08OCN1.SGM 08OCN1


Document Created: 2015-12-15 08:42:46
Document Modified: 2015-12-15 08:42:46
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on Agency guidances at any time.
ContactSara 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.
FR Citation80 FR 60917 
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