Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format (Periodic Benefit-Risk Evaluation Report); Availability, 20926-20927 [2013-08014]

Download as PDF 20926 Federal Register / Vol. 78, No. 67 / Monday, April 8, 2013 / Notices Silodosin will be posted to the docket at https:// www.regulations.gov. T V. Electronic Access Testosterone (multiple reference listed drugs and dosage forms) Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. S Z Zolpidem tartrate III. Drug Products for Which Revised Draft Product-Specific BE Recommendations Are Available FDA is announcing revised draft product-specific BE recommendations for drug products containing the following active ingredients: C Dated: April 2, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–08013 Filed 4–5–13; 8:45 am] BILLING CODE 4160–01–P Cefixime DEPARTMENT OF HEALTH AND HUMAN SERVICES D Food and Drug Administration Darunavir ethanolate Dextromethorphan hydrobromide; quinidine sulfate [Docket No. FDA–2013–D–0349] I Imatinib mesylate L Loteprednol etabonate For a complete history of previously published Federal Register notices related to product-specific BE recommendations, please go to https:// www.regulations.gov and enter docket number FDA–2007–D–0369. These draft and revised draft guidances are being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). These guidances represent the Agency’s current thinking on product-specific design of BE studies to support ANDAs. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. mstockstill on DSK4VPTVN1PROD with NOTICES IV. Comments Interested persons may submit either electronic comments on any of the specific BE recommendations posted on FDA’s Web site 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. The guidances, notices, and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and VerDate Mar<15>2010 20:02 Apr 05, 2013 Jkt 229001 Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format (Periodic Benefit-Risk Evaluation Report); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).’’ This guidance is intended to inform applicants of the conditions under which FDA will exercise its waiver authority to permit applicants to submit an International Conference on Harmonisation (ICH) E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) in place of the ICH E2C(R1) Periodic Safety Update Report (PSUR), U.S. periodic adverse drug experience report (PADER), or U.S. periodic adverse experience report (PAER), to satisfy the periodic safety reporting requirements in FDA regulations. The guidance describes the steps applicants can take to submit the PBRER, and discusses the format, content, submission deadline, and frequency of reporting for the PBRER. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 8, 2013. SUMMARY: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002, or the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by calling CBER at 1–800–835–4709 or 301–827–1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft 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: Jean Chung, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4466, Silver Spring, MD 20993–0002, 301–796–2380; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: ADDRESSES: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).’’ We are issuing the draft guidance to describe the conditions under which FDA will exercise its waiver authority to permit the holders of approved new drug applications, abbreviated new drug applications, and biologics license applications (applicants) to use the reporting format of the PBRER to submit periodic safety reports for their marketed products. The harmonized PBRER is intended to promote a consistent approach to periodic postmarket safety reporting among the ICH regions (the European Union, Japan, and the United States) and to enhance efficiency by reducing the number of reports generated for submissions to the regulatory authorities. FDA’s postmarket safety reporting regulations require applicants to submit periodic safety reports in the form of a E:\FR\FM\08APN1.SGM 08APN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 67 / Monday, April 8, 2013 / Notices Periodic Adverse Drug Experience Report (PADER) (for drugs) or a Periodic Adverse Experience Report (PAER) (for biologics) (21 CFR 314.80(c)(2) and 600.80(c)(2), respectively). FDA has routinely granted waivers under 21 CFR 314.90(b) and 600.90(b) permitting applicants to submit an internationally harmonized Periodic Safety Update Report (PSUR) prepared in accordance with ICH E2C (see 62 FR 27470 (May 19, 1997) and 69 FR 5551 (Feb. 5, 2004)) instead of a PADER/PAER under conditions stated in the waiver. On November 15, 2012, the ICH Steering Committee signed off on the ICH harmonized guideline ‘‘Periodic BenefitRisk Evaluation Report (PBRER) E2C(R2)’’ and recommended that the PBRER format be adopted by the ICH regulatory bodies of the three regions. Therefore, the new and more comprehensive report format, the PBRER, has superseded the PSUR report format. This guidance provides information on the steps applicants can take to submit a PBRER to the FDA in place of a PSUR, PADER, or PAER. The guidance discusses: (1) Applicants who have a waiver in place for their approved product to submit a PSUR instead of a PADER/PAER and (2) applicants who have not obtained a waiver and are currently submitting PADERs/PAERs as required under FDA regulations. Because the PBRER has replaced the PSUR as the ICH E2C harmonized postmarket safety report format, FDA is permitting applicants with an existing PSUR waiver to substitute the PBRER for the PSUR without submitting a new waiver request. This guidance describes the steps an applicant should take to submit the PBRER in place of the PSUR. For applicants who do not have a PSUR waiver in place for their approved application but would like to submit the PBRER in place of the PADER/PAER, this guidance provides information on how to submit a waiver request if they wish to do so. This guidance describes the content, format, and submission deadlines applicants should follow when submitting the PBRER, as well as U.S.specific appendices that should be submitted with the PBRER. It also explains how applicants can fulfill FDA’s annual reporting requirement while submitting a harmonized PBRER that covers a longer reporting interval. In addition, the guidance notifies applicants that they may submit requests to be waived of the quarterly reporting requirement and instead, to submit PBRERs on a 6-month basis. This draft guidance is being issued consistent with FDA’s good guidance VerDate Mar<15>2010 20:02 Apr 05, 2013 Jkt 229001 20927 practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on providing postmarket periodic safety reports in the ICH E2C(R2) PBRER format. 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. Dated: April 2, 2013. Leslie Kux, Assistant Commissioner for Policy. II. Comments Tobacco Products Scientific Advisory Committee; Notice of Meeting 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. Electronic Access Persons with access to the Internet may obtain the document at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. IV. The Paperwork Reduction Act of 1995 This draft guidance addresses information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520). The collections of information related to submission of waiver requests under §§ 314.90(a) and 600.90 have been approved under OMB control numbers 0910–0001 and 0910–0308. In accordance with the PRA, before publication of the final guidance document, FDA intends to solicit public comment and obtain OMB approval for any information collections recommended in this guidance that are new or that would represent material modifications to previously approved collections of information found in FDA regulations. PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 [FR Doc. 2013–08014 Filed 4–5–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Tobacco Products Scientific Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on April 30, 2013, from 8:30 a.m. to 5:30 p.m. Location: 9200 Corporate Blvd., Rockville, MD 20850, 1–877–287–1373. Contact Person: Caryn Cohen, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1–877–287–1373 (choose option 5), email: TPSAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: Modified risk tobacco products (MRTPs) are tobacco products that are sold or distributed for use to reduce harm or the risk of tobaccorelated disease associated with commercially marketed tobacco products. Before an MRTP can be introduced or delivered for introduction into interstate commerce, an order from E:\FR\FM\08APN1.SGM 08APN1

Agencies

[Federal Register Volume 78, Number 67 (Monday, April 8, 2013)]
[Notices]
[Pages 20926-20927]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08014]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0349]

Draft Guidance for Industry on Providing Postmarket Periodic
Safety Reports in the International Conference on Harmonisation E2C(R2)
Format (Periodic Benefit-Risk Evaluation Report); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Providing
Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic
Benefit-Risk Evaluation Report).'' This guidance is intended to inform
applicants of the conditions under which FDA will exercise its waiver
authority to permit applicants to submit an International Conference on
Harmonisation (ICH) E2C(R2) Periodic Benefit-Risk Evaluation Report
(PBRER) in place of the ICH E2C(R1) Periodic Safety Update Report
(PSUR), U.S. periodic adverse drug experience report (PADER), or U.S.
periodic adverse experience report (PAER), to satisfy the periodic
safety reporting requirements in FDA regulations. The guidance
describes the steps applicants can take to submit the PBRER, and
discusses the format, content, submission deadline, and frequency of
reporting for the PBRER.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 8, 2013.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The guidance may also be obtained by calling
CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
Submit electronic comments on the draft 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: Jean Chung, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 4466, Silver Spring, MD 20993-0002, 301-796-2380; or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17),
Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
entitled ``Providing Postmarket Periodic Safety Reports in the ICH
E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).'' We are
issuing the draft guidance to describe the conditions under which FDA
will exercise its waiver authority to permit the holders of approved
new drug applications, abbreviated new drug applications, and biologics
license applications (applicants) to use the reporting format of the
PBRER to submit periodic safety reports for their marketed products.
The harmonized PBRER is intended to promote a consistent approach to
periodic postmarket safety reporting among the ICH regions (the
European Union, Japan, and the United States) and to enhance efficiency
by reducing the number of reports generated for submissions to the
regulatory authorities.
FDA's postmarket safety reporting regulations require applicants to
submit periodic safety reports in the form of a

[[Page 20927]]

Periodic Adverse Drug Experience Report (PADER) (for drugs) or a
Periodic Adverse Experience Report (PAER) (for biologics) (21 CFR
314.80(c)(2) and 600.80(c)(2), respectively). FDA has routinely granted
waivers under 21 CFR 314.90(b) and 600.90(b) permitting applicants to
submit an internationally harmonized Periodic Safety Update Report
(PSUR) prepared in accordance with ICH E2C (see 62 FR 27470 (May 19,
1997) and 69 FR 5551 (Feb. 5, 2004)) instead of a PADER/PAER under
conditions stated in the waiver. On November 15, 2012, the ICH Steering
Committee signed off on the ICH harmonized guideline ``Periodic
Benefit-Risk Evaluation Report (PBRER) E2C(R2)'' and recommended that
the PBRER format be adopted by the ICH regulatory bodies of the three
regions. Therefore, the new and more comprehensive report format, the
PBRER, has superseded the PSUR report format.
This guidance provides information on the steps applicants can take
to submit a PBRER to the FDA in place of a PSUR, PADER, or PAER. The
guidance discusses: (1) Applicants who have a waiver in place for their
approved product to submit a PSUR instead of a PADER/PAER and (2)
applicants who have not obtained a waiver and are currently submitting
PADERs/PAERs as required under FDA regulations. Because the PBRER has
replaced the PSUR as the ICH E2C harmonized postmarket safety report
format, FDA is permitting applicants with an existing PSUR waiver to
substitute the PBRER for the PSUR without submitting a new waiver
request. This guidance describes the steps an applicant should take to
submit the PBRER in place of the PSUR. For applicants who do not have a
PSUR waiver in place for their approved application but would like to
submit the PBRER in place of the PADER/PAER, this guidance provides
information on how to submit a waiver request if they wish to do so.
This guidance describes the content, format, and submission
deadlines applicants should follow when submitting the PBRER, as well
as U.S.-specific appendices that should be submitted with the PBRER. It
also explains how applicants can fulfill FDA's annual reporting
requirement while submitting a harmonized PBRER that covers a longer
reporting interval. In addition, the guidance notifies applicants that
they may submit requests to be waived of the quarterly reporting
requirement and instead, to submit PBRERs on a 6-month basis.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on providing
postmarket periodic safety reports in the ICH E2C(R2) PBRER format. 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. Electronic Access

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

IV. The Paperwork Reduction Act of 1995

This draft guidance addresses information collection provisions
that are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520).
The collections of information related to submission of waiver requests
under Sec. Sec. 314.90(a) and 600.90 have been approved under OMB
control numbers 0910-0001 and 0910-0308. In accordance with the PRA,
before publication of the final guidance document, FDA intends to
solicit public comment and obtain OMB approval for any information
collections recommended in this guidance that are new or that would
represent material modifications to previously approved collections of
information found in FDA regulations.

Dated: April 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08014 Filed 4-5-13; 8:45 am]
BILLING CODE 4160-01-P

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