81 FR 85976 - Providing Postmarketing Periodic Safety Reports in the International Council for Harmonisation E2C(R2) Format (Periodic Benefit-Risk Evaluation Report); Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 229 (November 29, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 229 (November 29, 2016)
| Page Range | 85976-85977 | |
| FR Document | 2016-28606 |
[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)] [Notices] [Pages 85976-85977] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-28606] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0349] Providing Postmarketing Periodic Safety Reports in the International Council for Harmonisation E2C(R2) Format (Periodic Benefit-Risk Evaluation Report); Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Providing Postmarketing 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 Council for Harmonisation (ICH) (formerly International Conference on Harmonisation) 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: Submit either electronic or written comments on the guidance 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-2013-D-0349 for ``Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).'' 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 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. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. 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, Food and Drug Administration,10903 New Hampshire Ave., Bldg. 71, Rm. 3128, [[Page 85977]] Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).'' We are issuing the 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 postmarketing safety reporting among the ICH regions and to enhance efficiency by reducing the number of reports generated for submissions to the regulatory authorities. FDA's postmarketing safety reporting regulations require applicants to submit periodic safety reports in the form of a 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, February 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 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 postmarketing 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 instead of the PSUR. For applicants who do not have a PSUR waiver for their approved application but would like to submit the PBRER instead 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, FDA will consider requests to waive the quarterly reporting requirement. This guidance finalizes the draft guidance for industry entitled ``Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report),'' which was announced in the Federal Register of April 8, 2013 (78 FR 20926). We reviewed the comments received on the draft guidance and revised several sections of the guidance in response to comments and questions on topics such as the submission of the nonexpedited individual case safety reports, waivers of the quarterly reporting requirement, the supplemental information to be provided with the PSUR/PBRER, handling gaps in reporting with changes to the date of the data lock point for the reporting interval, and accepted formats for the periodic safety report. In response to comments, we also clarified the text in the examples that were given in the draft guidance. 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 providing postmarketing periodic safety reports in the ICH E2C(R2) PBRER format. 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 of the applicable statutes and regulations. II. Electronic Access Persons with access to the Internet may obtain the document at https://www.regulations.gov/, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 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 (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. The guidance also refers to collections of information that have been approved under OMB control number 0910-0771 related to providing waiver-related materials in accordance with the guidance. Dated: November 22, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-28606 Filed 11-28-16; 8:45 am] BILLING CODE 4164-01-P
![85976 Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices
petitions (two copies are required) to the instructions for submitting comments. the claimed confidential information, in
Division of Dockets Management (HFA– Comments submitted electronically, its consideration of comments. The
305), Food and Drug Administration, including attachments, to https:// second copy, which will have the
5630 Fishers Lane, Rm. 1061, Rockville, www.regulations.gov/ will be posted to claimed confidential information
MD 20852. the docket unchanged. Because your redacted/blacked out, will be available
Dated: November 22, 2016. comment will be made public, you are for public viewing and posted on
solely responsible for ensuring that your https://www.regulations.gov/. Submit
Leslie Kux,
comment does not include any both copies to the Division of Dockets
Associate Commissioner for Policy.
confidential information that you or a Management. If you do not wish your
[FR Doc. 2016–28654 Filed 11–28–16; 8:45 am] third party may not wish to be posted, name and contact information to be
BILLING CODE 4164–01–P such as medical information, your or made publicly available, you can
anyone else’s Social Security number, or provide this information on the cover
confidential business information, such sheet and not in the body of your
DEPARTMENT OF HEALTH AND as a manufacturing process. Please note comments and you must identify this
HUMAN SERVICES that if you include your name, contact information as ‘‘confidential.’’ Any
information, or other information that information marked as ‘‘confidential’’
Food and Drug Administration
identifies you in the body of your will not be disclosed except in
[Docket No. FDA–2013–D–0349] comments, that information will be accordance with 21 CFR 10.20 and other
posted on https://www.regulations.gov/. applicable disclosure law. For more
Providing Postmarketing Periodic • If you want to submit a comment information about FDA’s posting of
Safety Reports in the International with confidential information that you comments to public dockets, see 80 FR
Council for Harmonisation E2C(R2) do not wish to be made available to the 56469, September 18, 2015, or access
Format (Periodic Benefit-Risk public, submit the comment as a the information at: http://www.fda.gov/
Evaluation Report); Guidance for written/paper submission and in the regulatoryinformation/dockets/
Industry; Availability manner detailed (see ‘‘Written/Paper default.htm.
AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’).
Docket: For access to the docket to
HHS. Written/Paper Submissions read background documents or the
ACTION: Notice of availability. Submit written/paper submissions as electronic and written/paper comments
follows: received, go to https://
SUMMARY: The Food and Drug
• Mail/Hand delivery/Courier (for www.regulations.gov/ and insert the
Administration (FDA or Agency) is docket number, found in brackets in the
written/paper submissions): Division of
announcing the availability of a heading of this document, into the
Dockets Management (HFA–305), Food
guidance for industry entitled ‘‘Search’’ box and follow the prompts
and Drug Administration, 5630 Fishers
‘‘Providing Postmarketing Periodic and/or go to the Division of Dockets
Lane, Rm. 1061, Rockville, MD 20852.
Safety Reports in the ICH E2C(R2) • For written/paper comments Management, 5630 Fishers Lane, Rm.
Format (Periodic Benefit-Risk submitted to the Division of Dockets 1061, Rockville, MD 20852.
Evaluation Report).’’ This guidance is Management, FDA will post your
intended to inform applicants of the Submit written requests for single
comment, as well as any attachments, copies of this guidance to the Division
conditions under which FDA will except for information submitted,
exercise its waiver authority to permit of Drug Information, Center for Drug
marked and identified, as confidential, Evaluation and Research, Food and
applicants to submit an International if submitted as detailed in
Council for Harmonisation (ICH) Drug Administration, 10001 New
‘‘Instructions.’’ Hampshire Ave., Hillandale Building,
(formerly International Conference on Instructions: All submissions received
Harmonisation) E2C(R2) Periodic 4th Floor, Silver Spring, MD 20993–
must include the Docket No. FDA– 0002; or the Office of Communication,
Benefit-Risk Evaluation Report (PBRER) 2013–D–0349 for ‘‘Providing
in place of the ICH E2C(R1) Periodic Outreach and Development, Center for
Postmarketing Periodic Safety Reports Biologics Evaluation and Research
Safety Update Report (PSUR), U.S. in the ICH E2C(R2) Format (Periodic
Periodic adverse drug experience report Benefit-Risk Evaluation Report).’’ (CBER), Food and Drug Administration,
(PADER), or U.S. Periodic adverse 10903 New Hampshire Ave., Bldg. 71,
Received comments will be placed in Rm. 3128, Silver Spring, MD 20993–
experience report (PAER), to satisfy the the docket and, except for those
periodic safety reporting requirements 0002. Send one self-addressed adhesive
submitted as ‘‘Confidential label to assist that office in processing
in FDA regulations. The guidance Submissions,’’ publicly viewable at
describes the steps applicants can take your requests. The guidance may also be
https://www.regulations.gov/ or at the obtained by mail by calling CBER at 1–
to submit the PBRER, and discusses the Division of Dockets Management
format, content, submission deadline, 800–835–4709 or 240–402–8010. See
between 9 a.m. and 4 p.m., Monday the SUPPLEMENTARY INFORMATION section
and frequency of reporting for the through Friday.
PBRER. for electronic access to the guidance
• Confidential Submissions—To document.
DATES: Submit either electronic or submit a comment with confidential
written comments on the guidance at information that you do not wish to be FOR FURTHER INFORMATION CONTACT: Jean
any time. made publicly available, submit your Chung, Center for Drug Evaluation and
asabaliauskas on DSK3SPTVN1PROD with NOTICES
ADDRESSES: You may submit comments comments only as a written/paper Research, Food and Drug
as follows: submission. You should submit two Administration, 10903 New Hampshire
copies total. One copy will include the Ave., Bldg. 22, Rm. 4466, Silver Spring,
Electronic Submissions information you claim to be confidential MD 20993–0002, 301–796–2380; or
Submit electronic comments in the with a heading or cover note that states Stephen Ripley, Center for Biologics
following way: ‘‘THIS DOCUMENT CONTAINS Evaluation and Research, Food and
• Federal eRulemaking Portal: https:// CONFIDENTIAL INFORMATION.’’ The Drug Administration,10903 New
www.regulations.gov/. Follow the Agency will review this copy, including Hampshire Ave., Bldg. 71, Rm. 3128,
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![Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices 85977
Silver Spring, MD 20993–0002, 240– applicants with an existing PSUR Guidances/default.htm, or http://
402–7911. waiver to substitute the PBRER for the www.fda.gov/BiologicsBloodVaccines/
SUPPLEMENTARY INFORMATION: PSUR without submitting a new waiver GuidanceComplianceRegulatory
request. This guidance describes the Information/Guidances/default.htm.
I. Background steps an applicant should take to submit
III. The Paperwork Reduction Act of
FDA is announcing the availability of the PBRER instead of the PSUR. For
1995
a guidance for industry entitled applicants who do not have a PSUR
‘‘Providing Postmarketing Periodic waiver for their approved application This guidance refers to previously
Safety Reports in the ICH E2C(R2) but would like to submit the PBRER approved collections of information that
Format (Periodic Benefit-Risk instead of the PADER/PAER, this are subject to review by the Office of
Evaluation Report).’’ We are issuing the guidance provides information on how Management and Budget (OMB) under
guidance to describe the conditions to submit a waiver request if they wish the Paperwork Reduction Act of 1995
under which FDA will exercise its to do so. (PRA) (44 U.S.C. 3501–3520). The
waiver authority to permit the holders This guidance describes the content, collections of information related to
of approved new drug applications, format, and submission deadlines submission of waiver requests under
abbreviated new drug applications, and applicants should follow when §§ 314.90(a) and 600.90 have been
biologics license applications submitting the PBRER, as well as U.S.- approved under OMB control numbers
(applicants) to use the reporting format specific appendices that should be 0910–0001 and 0910–0308. The
of the PBRER to submit periodic safety submitted with the PBRER. It also guidance also refers to collections of
reports for their marketed products. The explains how applicants can fulfill information that have been approved
harmonized PBRER is intended to FDA’s annual reporting requirement under OMB control number 0910–0771
promote a consistent approach to while submitting a harmonized PBRER related to providing waiver-related
periodic postmarketing safety reporting that covers a longer reporting interval. materials in accordance with the
among the ICH regions and to enhance In addition, FDA will consider requests guidance.
efficiency by reducing the number of to waive the quarterly reporting Dated: November 22, 2016.
reports generated for submissions to the requirement. Leslie Kux,
regulatory authorities. This guidance finalizes the draft Associate Commissioner for Policy.
FDA’s postmarketing safety reporting guidance for industry entitled
[FR Doc. 2016–28606 Filed 11–28–16; 8:45 am]
regulations require applicants to submit ‘‘Providing Postmarket Periodic Safety
BILLING CODE 4164–01–P
periodic safety reports in the form of a Reports in the ICH E2C(R2) Format
Periodic adverse drug experience report (Periodic Benefit-Risk Evaluation
(PADER) (for drugs) or a Periodic Report),’’ which was announced in the
DEPARTMENT OF HEALTH AND
adverse experience report (PAER) (for Federal Register of April 8, 2013 (78 FR
HUMAN SERVICES
biologics) (21 CFR 314.80(c)(2) and 20926). We reviewed the comments
600.80(c)(2), respectively). FDA has received on the draft guidance and Food and Drug Administration
routinely granted waivers under 21 CFR revised several sections of the guidance
314.90(b) and 600.90(b) permitting in response to comments and questions [Docket No. FDA–2016–D–2635]
applicants to submit an internationally on topics such as the submission of the
The Judicious Use of Medically
harmonized Periodic Safety Update nonexpedited individual case safety
Important Antimicrobial Drugs in Food-
Report (PSUR) prepared in accordance reports, waivers of the quarterly
Producing Animals; Establishing
with ICH E2C (see 62 FR 27470, May 19, reporting requirement, the supplemental
Appropriate Durations of Therapeutic
1997) and 69 FR 5551, February 5, information to be provided with the
Administration; Extension of Comment
2004)) instead of a PADER/PAER under PSUR/PBRER, handling gaps in
Period
conditions stated in the waiver. On reporting with changes to the date of the
November 15, 2012, the ICH Steering data lock point for the reporting AGENCY: Food and Drug Administration,
Committee signed off on the ICH interval, and accepted formats for the HHS.
harmonized guideline ‘‘Periodic Benefit- periodic safety report. In response to ACTION: Notice; extension of comment
Risk Evaluation Report (PBRER) comments, we also clarified the text in period.
E2C(R2)’’ and recommended that the the examples that were given in the
PBRER format be adopted by the ICH draft guidance. SUMMARY: The Food and Drug
regulatory bodies of the three regions. This guidance is being issued Administration (FDA or we) is
Therefore, the new and more consistent with FDA’s good guidance extending the comment period for a
comprehensive report format, the practices regulation (21 CFR 10.115). notice that appeared in the Federal
PBRER, has superseded the PSUR report The guidance represents the current Register of September 14, 2016. In that
format. thinking of FDA on providing notice, FDA requested comments
This guidance provides information postmarketing periodic safety reports in regarding the establishment of
on the steps applicants can take to the ICH E2C(R2) PBRER format. It does appropriately targeted durations of use
submit a PBRER to the FDA in place of not establish any rights for any person of antimicrobial drugs of importance to
a PSUR, PADER, or PAER. The guidance and is not binding on FDA or the public. human medicine (i.e., medically
discusses: (1) Applicants who have a You can use an alternative approach if important antimicrobial drugs) when
waiver for their approved product to they are administered in the feed or
asabaliauskas on DSK3SPTVN1PROD with NOTICES
it satisfies the requirements of the
submit a PSUR instead of a PADER/ applicable statutes and regulations. water of food-producing animals for
PAER and (2) applicants who have not therapeutic purposes. The Agency is
obtained a waiver and are currently II. Electronic Access taking this action in response to
submitting PADERs/PAERs as required Persons with access to the Internet requests for an extension to allow
under FDA regulations. Because the may obtain the document at https:// interested persons additional time to
PBRER has replaced the PSUR as the www.regulations.gov/, http:// submit comments.
ICH E2C harmonized postmarketing www.fda.gov/Drugs/Guidance DATES: FDA is extending the comment
safety report format, FDA is permitting ComplianceRegulatoryInformation/ period on the request for comments
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Document Created: 2016-11-29 00:33:25
Document Modified: 2016-11-29 00:33:25
| 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 of availability. | |
| Dates | Submit either electronic or written comments on the guidance at any time. | |
| 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, Food and Drug Administration,10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 81 FR 85976 |
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