81 FR 46938 - E2C(R2) Periodic Benefit-Risk Evaluation Report and E2C(R2) Periodic Benefit-Risk Evaluation Report-Questions and Answers; International Council for Harmonisation; Guidances for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 138 (July 19, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 138 (July 19, 2016)
| Page Range | 46938-46940 | |
| FR Document | 2016-17009 |
[Federal Register Volume 81, Number 138 (Tuesday, July 19, 2016)] [Notices] [Pages 46938-46940] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17009] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0315] E2C(R2) Periodic Benefit-Risk Evaluation Report and E2C(R2) Periodic Benefit-Risk Evaluation Report--Questions and Answers; International Council for Harmonisation; Guidances for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of guidances for industry entitled ``E2C(R2) Periodic Benefit-Risk Evaluation'' (E2C(R2) guidance) and ``E2C(R2) Periodic Benefit-Risk Evaluation Report--Questions and Answers'' (E2C(R2) Q&A guidance). These guidances were prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The E2C(R2) draft guidance, issued April 11, 2012, updated and combined two ICH guidances, ``E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum to the E2C guidance). The E2C(R2) guidance is intended to describe the format, content, and timing of a Periodic Benefit-Risk Evaluation Report (PBRER) for an approved drug or biologic, and it finalizes the draft guidance. The E2C(R2) Q&A guidance is a supplementary guidance that is intended to clarify key issues in the E2C(R2) guidance. 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''). [[Page 46939]] 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-2012-D-0315 for ``E2C(R2) Periodic Benefit-Risk Evaluation Report and E2C(R2) Periodic Benefit-Risk Evaluation Report--Questions and Answers; International Council for Harmonisation; Guidances 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 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 these guidances 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 guidances 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 documents. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Maureen Melvin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4480, Silver Spring, MD 20993-0002, 301-796-5366; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. Regarding the ICH: Amanda Roache, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1128, Silver Spring, MD 20993-0002, 301-796-4548. SUPPLEMENTARY INFORMATION: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products for human use among regulators around the world. The six founding members of the ICH are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; CDER and CBER, FDA; and the Pharmaceutical Research and Manufacturers of America. The Standing Members of the ICH Association include Health Canada and Swissmedic. Any party eligible as a Member in accordance with the ICH Articles of Association can apply for membership in writing to the ICH Secretariat. The ICH Secretariat, which coordinates the preparation of documentation, operates as an international nonprofit organization and is funded by the Members of the ICH Association. The ICH Assembly is the overarching body of the Association and includes representatives from each of the ICH members and observers. In the Federal Register of April 11, 2012 (77 FR 21782), FDA published a notice announcing the availability of a draft guidance entitled ``E2C(R2) Periodic Benefit-Risk Evaluation Report.'' The draft E2C(R2) guidance updated and combined the E2C guidance and the addendum to the E2C guidance. The notice gave interested persons an opportunity to submit comments by May 11, 2012. After consideration of the comments received and revisions to the guidance, a final draft of the guidance was submitted to the ICH Steering Committee and endorsed by the regulatory agencies in November 2012. The E2C(R2) guidance provides guidance on the format, content, and timing of a PBRER for an approved drug or biologic, and it finalizes the draft guidance. The PBRER will serve as a common standard for periodic reporting on approved drugs or biologics among the ICH regions. The harmonized PBRER is intended to promote a consistent approach to periodic postmarket safety reporting among the ICH regions and to enhance efficiency by reducing the number of reports [[Page 46940]] generated for submission to the regulatory authorities. Since the E2C(R2) draft guidance was made available in 2012, ICH has identified questions linked to the interpretation and application of the E2C(R2) guidance. The E2C(R2) Q&A guidance is intended to clarify questions relating to implementation of the E2C(R2) guidance. These guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidances represent the current thinking of FDA on the E2C(R2) PBRER. They do not establish any rights for any person and are 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. The Paperwork Reduction Act of 1995 These guidances refer to previously approved collections of information found in FDA regulations. These collections of information 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 collection of information in the ``Guidance on Reporting in Accordance with International Council for Harmonisation--Periodic Benefit-Risk Evaluation Report (E2C(R2)) and Providing Waiver-Related Materials'' has been approved under OMB control number 0910-0771. The guidances also reference other collections of information. The collection of information in 21 CFR 314.80 has been approved under OMB control number 0910-0230, and the collection of information in 21 CFR 600.80 has been approved under OMB control number 0910-0308. III. Electronic Access Persons with access to the Internet may obtain the document at http://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Dated: July 13, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-17009 Filed 7-18-16; 8:45 am] BILLING CODE 4164-01-P
![46938 Federal Register / Vol. 81, No. 138 / Tuesday, July 19, 2016 / Notices
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR Section responses per burden per Total hours
respondents responses
respondent response
56.109(d) Written statement about minimal risk research
when documentation of informed consent is waived ....... 2,520 2 5,040 0.5 2,520
(30 minutes)
56.109(e) IRB written notification to approve or disapprove
research; 56.109(f) Continuing review; 50.25 Elements
of informed consent; and 50.27 Documentation of in-
formed consent ................................................................. 2,520 40 100,800 1 100,800
50.24 Exception from informed consent requirements for
emergency research ......................................................... 8 3 24 1 24
56.113 Suspension or termination of IRB approval of re-
search ............................................................................... 2,520 1 2,520 0.5 1,260
(30 minutes)
56.120(a) IRB response to lesser administrative actions
for noncompliance ............................................................ 7 1 7 10 70
56.123 Reinstatement of an IRB or an institution ............... 1 1 1 5 5
Total .............................................................................. ........................ ........................ ........................ ........................ 104,679
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
21 CFR Section burden per Total hours
respondents per disclosures disclosure
respondent
56.109(g) IRB written statement about public disclosures
to sponsor of emergency research under 50.24 .............. 8 2 16 1 16
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 13, 2016. Questions and Answers’’ (E2C(R2) Q&A Electronic Submissions
Leslie Kux, guidance). These guidances were Submit electronic comments in the
Associate Commissioner for Policy. prepared under the auspices of the following way:
[FR Doc. 2016–17016 Filed 7–18–16; 8:45 am] International Council for Harmonisation • Federal eRulemaking Portal: http://
BILLING CODE 4164–01–P (ICH), formerly the International www.regulations.gov. Follow the
Conference on Harmonisation. The instructions for submitting comments.
E2C(R2) draft guidance, issued April 11, Comments submitted electronically,
DEPARTMENT OF HEALTH AND 2012, updated and combined two ICH including attachments, to http://
HUMAN SERVICES guidances, ‘‘E2C Clinical Safety Data www.regulations.gov will be posted to
Management: Periodic Safety Update the docket unchanged. Because your
Food and Drug Administration Reports for Marketed Drugs’’ (E2C comment will be made public, you are
[Docket No. FDA–2012–D–0315] guidance) and ‘‘Addendum to E2C solely responsible for ensuring that your
Clinical Safety Data Management: comment does not include any
E2C(R2) Periodic Benefit-Risk Periodic Safety Update Reports for confidential information that you or a
Evaluation Report and E2C(R2) Marketed Drugs’’ (addendum to the E2C third party may not wish to be posted,
Periodic Benefit-Risk Evaluation guidance). The E2C(R2) guidance is such as medical information, your or
Report—Questions and Answers; intended to describe the format, content, anyone else’s Social Security number, or
International Council for and timing of a Periodic Benefit-Risk confidential business information, such
Harmonisation; Guidances for Evaluation Report (PBRER) for an as a manufacturing process. Please note
Industry; Availability approved drug or biologic, and it that if you include your name, contact
AGENCY: Food and Drug Administration, finalizes the draft guidance. The information, or other information that
HHS. E2C(R2) Q&A guidance is a identifies you in the body of your
supplementary guidance that is comments, that information will be
ACTION: Notice.
intended to clarify key issues in the posted on http://www.regulations.gov.
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY: The Food and Drug E2C(R2) guidance. • If you want to submit a comment
Administration (FDA or Agency) is with confidential information that you
DATES: Submit either electronic or
announcing the availability of guidances do not wish to be made available to the
written comments on Agency guidances
for industry entitled ‘‘E2C(R2) Periodic public, submit the comment as a
at any time.
Benefit-Risk Evaluation’’ (E2C(R2) written/paper submission and in the
guidance) and ‘‘E2C(R2) Periodic ADDRESSES: You may submit comments manner detailed (see ‘‘Written/Paper
Benefit-Risk Evaluation Report— as follows: Submissions’’ and ‘‘Instructions’’).
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![46940 Federal Register / Vol. 81, No. 138 / Tuesday, July 19, 2016 / Notices
generated for submission to the Dated: July 13, 2016. final rule that requires human drug
regulatory authorities. Leslie Kux, product and biological product labels to
Since the E2C(R2) draft guidance was Associate Commissioner for Policy. have bar codes. Specifically, the rule
made available in 2012, ICH has [FR Doc. 2016–17009 Filed 7–18–16; 8:45 am] requires bar codes on most human
identified questions linked to the BILLING CODE 4164–01–P prescription drug products and on over-
interpretation and application of the the-counter (OTC) drug products that
E2C(R2) guidance. The E2C(R2) Q&A are dispensed under an order and
DEPARTMENT OF HEALTH AND commonly used in health care facilities.
guidance is intended to clarify questions
HUMAN SERVICES The rule also requires machine-readable
relating to implementation of the
E2C(R2) guidance. information on blood and blood
Food and Drug Administration
components. For human prescription
These guidances are being issued [Docket No. FDA–2012–N–0873] drug products and OTC drug products
consistent with FDA’s good guidance
that are dispensed under an order and
practices regulation (21 CFR 10.115). Agency Information Collection
commonly used in health care facilities,
The guidances represent the current Activities; Submission for Office of
the bar code must contain the NDC
thinking of FDA on the E2C(R2) PBRER. Management and Budget Review;
Comment Request; Bar Code Label number for the product. For blood and
They do not establish any rights for any
Requirement for Human Drug and blood components, the rule specifies the
person and are not binding on FDA or
Biological Products minimum contents of the label in a
the public. You can use an alternative
format that is machine-readable and
approach if it satisfies the requirements AGENCY: Food and Drug Administration, approved for use by the Director, Center
of the applicable statutes and HHS. for Biologics Evaluation and Research.
regulations. ACTION: Notice. We believe the rule helps to reduce the
II. The Paperwork Reduction Act of SUMMARY: The Food and Drug number of medication errors in
1995 Administration (FDA) is announcing hospitals and other health care settings
that a proposed collection of by allowing health care professionals to
These guidances refer to previously use bar code scanning equipment to
information has been submitted to the
approved collections of information verify that the right drug (in the right
Office of Management and Budget
found in FDA regulations. These (OMB) for review and clearance under dose and right route of administration)
collections of information are subject to the Paperwork Reduction Act of 1995. is being given to the right patient at the
review by the Office of Management and DATES: Fax written comments on the right time.
Budget (OMB) under the Paperwork collection of information by August 18, While most of the information
Reduction Act of 1995 (PRA) (44 U.S.C. 2016. collection burdens created by the final
3501–3520). The collection of ADDRESSES: To ensure that comments on rule have now been incorporated into
information in the ‘‘Guidance on the information collection are received, currently approved information
Reporting in Accordance with OMB recommends that written collections supporting the applicable
International Council for comments be faxed to the Office of regulations, respondents to the
Harmonisation—Periodic Benefit-Risk Information and Regulatory Affairs, collection may continue to seek an
Evaluation Report (E2C(R2)) and OMB, Attn: FDA Desk Officer, FAX: exemption from the bar code label
Providing Waiver-Related Materials’’ 202–395–7285, or emailed to oira_
requirement under § 201.25(d) (21 CFR
has been approved under OMB control submission@omb.eop.gov. All
201.25(d)). Section 201.25(d) requires
number 0910–0771. The guidances also comments should be identified with the
OMB control number 0910–0537. Also submission of a written request for an
reference other collections of
include the FDA docket number found exemption and describes the
information. The collection of
in brackets in the heading of this information that must be included in
information in 21 CFR 314.80 has been
document. such a request. Based on the number of
approved under OMB control number
exemption requests we have received
0910–0230, and the collection of FOR FURTHER INFORMATION CONTACT: FDA
previously, we estimate that
information in 21 CFR 600.80 has been PRA Staff, Office of Operations, Food
approximately 2 exemption requests
approved under OMB control number and Drug Administration, Three White
Flint North 10A–12M, 11601 will be submitted annually and that
0910–0308.
Landsdown Street, North Bethesda, MD each exemption request will require 24
III. Electronic Access 20852, PRAStaff@fda.hhs.gov. hours to complete. This results in an
SUPPLEMENTARY INFORMATION: In
annual reporting burden of 48 hours, as
Persons with access to the Internet reflected below in Table 1.
may obtain the document at http:// compliance with 44 U.S.C. 3507, FDA
www.regulations.gov, http:// has submitted the following proposed In the Federal Register of December
www.fda.gov/Drugs/Guidance collection of information to OMB for 15, 2015 (80 FR 77637) FDA published
review and clearance. a 60-day notice requesting public
ComplianceRegulatoryInformation/
Guidances/default.htm, or http:// Bar Code Label Requirement for comment on the proposed collection of
www.fda.gov/BiologicsBloodVaccines/ Human Drug Products and Blood; OMB information. No comments were
GuidanceComplianceRegulatory Control No. 0910–0537—Extension received.
mstockstill on DSK3G9T082PROD with NOTICES
Information/Guidances/default.htm. In the Federal Register of February We estimate the burden of this
26, 2004 (69 FR 9120), FDA issued a collection of information as follows:
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Document Created: 2016-07-19 01:11:04
Document Modified: 2016-07-19 01:11:04
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Regarding the guidance: Maureen Melvin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4480, Silver Spring, MD 20993-0002, 301-796-5366; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 81 FR 46938 |
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