82 FR 37098 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Providing Waiver-Related Materials in Accordance With the Guidance for Industry on Providing Post-Market Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 151 (August 8, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 151 (August 8, 2017)
| Page Range | 37098-37100 | |
| FR Document | 2017-16647 |
[Federal Register Volume 82, Number 151 (Tuesday, August 8, 2017)] [Notices] [Pages 37098-37100] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16647] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0349] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Providing Waiver- Related Materials in Accordance With the Guidance for Industry on Providing Post-Market Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by September 7, 2017. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0771. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Providing Waiver-Related Materials in Accordance With the Guidance for Industry on Providing Post-Market Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format (Periodic Benefit-Risk Evaluation Report); OMB Control Number 0910-0771-- Extension The International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use issued, on November 15, 2012, the ICH harmonized tripartite guideline entitled ``Periodic Benefit-Risk Evaluation Report (PBRER) E2C(R2)'' (the PBRER guideline) (available at https://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html). The PBRER guideline is intended to promote a consistent approach to periodic post-marketing safety reporting among the ICH regions, to enhance efficiency and reduce burden by reducing the number of reports generated for submission to the regulatory authorities. The PBRER is intended to provide a common standard for periodic reporting on approved drugs or biologics among the ICH regions. FDA currently has OMB approval for the required submission of periodic adverse drug experience reports (PADER) for drugs subject to a new drug application (NDA) or an abbreviated new drug application (ANDA) (Sec. [thinsp]314.80(c)(2) (21 CFR 314.80(c)(2)) (OMB control number 0910-0230), and for the required submission of periodic adverse experience reports (PAER) for drugs subject to a biologics license application (BLA) (Sec. [thinsp]600.80(c)(2) (21 CFR 600.80(c)(2)) (OMB control number 0910-0308). [[Page 37099]] There is considerable overlap in the information required under Sec. Sec. [thinsp]314.80(c)(2) and 600.80(c)(2) and the information requested in a periodic safety report using the ICH E2C(R2) PBRER format. Applicants subject to periodic safety reporting requirements under FDA regulations could choose to continue to submit the reports as specified in those regulations, and would be permitted to submit reports in the PBRER format and submit reports as specified in FDA regulations with an approved waiver. Companies who submit periodic reports on the same drug to multiple regulators, including not only the United States, but, also the European Union, Japan, and regulators in other countries who have elected to adopt the ICH standards, may find it in their interest to prepare a single PBRER, rather than preparing multiple types of reports for multiple regulators. As a result, FDA, in the Federal Register of November 29, 2016 (81 FR 85976), announced the availability of the guidance for industry entitled ``Providing Post- marketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)'' to indicate its willingness to accept post-market periodic safety reports using the ICH PBRER format in lieu of the specific reports described in FDA regulations. Because FDA regulations in Sec. Sec. [thinsp]314.80(c)(2) and 600.80(c)(2) include specific requirements for periodic safety reports, in order for an applicant to submit an alternative report, such as the PBRER, for a given product, FDA must grant a waiver. Existing regulations permit applicants to request waivers of any post-marketing safety reporting requirement, and the information collections associated with such waiver requests generally are approved under existing control numbers. (See Sec. [thinsp]314.90(a), waivers for drugs subject to NDAs and ANDAs, approved under OMB control number 0910-0001, and Sec. [thinsp]600.90(a), waivers for products subject to BLAs, approved under OMB control number 0910-0308.) The November 29, 2016, guidance both explains conditions under which applicants that have previously received waivers to submit reporting information in the format of the previous ICH guidance would be permitted to apply those existing waivers to the submission of PBRERs, and also advises how applicants that have not previously obtained a waiver may submit waiver requests to submit the PBRER. There are information collections proposed in the November 29, 2016, guidance that are related to waivers specifically to enable the submission of PBRERs, and these information collections are not already addressed under the approved control numbers covering waiver submissions and periodic safety reports generally. FDA has previously granted waiver requests, submitted under Sec. Sec. [thinsp]314.90(a) and 600.90(a), that allow applicants to prepare and submit reports using the periodic safety update report (PSUR) format described in FDA's 1996 and 2004 ICH E2C guidance. In accordance with the recommendations of the November 29, 2016, guidance, if an applicant already has a PSUR waiver in place for a given approved application, FDA will consider the existing PSUR waiver to allow the applicant to submit a PBRER instead of a PSUR because the PBRER replaces the PSUR for post-marketing periodic safety reporting for that application. The applicant would not need to submit a new waiver request unless the applicant wishes to change the frequency of reporting. FDA will consider requests to be waived of the quarterly reporting requirement but will not waive applicants of the annual reporting requirement. If an applicant submits a PBRER in place of the PSUR and uses a different data lock point, the applicant should submit overlapping reports or submit a one-time PADER/PAER in order to cover the gap in reporting intervals. The applicant should submit notification to the application(s), indicating the change in data lock point and should include a description of the measures taken to ensure that there are no resulting gaps in reporting. If an applicant submits a PBRER in place of the PSUR and uses a different reporting frequency for the PBRER than was used for the PSUR, the continued validity of the waiver will be conditioned on the submission of a PADER/PAER as needed to fulfill the reporting frequency requirement under FDA regulations. The applicant should submit a notification to the application(s), describing this change and the measures taken to ensure that the periodicity requirements are being met. FDA expects approximately 187 waiver requests and notifications to include the additional information described previously in this document for using a different data lock point and/or for using a different reporting frequency when submitting a PBRER. FDA expects approximately 55 applicants to make these submissions, and we estimate that the time for submitting the additional information described previously would be on average approximately 1 hour for each waiver request or notification. If an applicant does not have a PSUR waiver in place for an approved application, the applicant may submit a waiver request under Sec. [thinsp]314.90(a) or Sec. [thinsp]600.90(a) to submit a PBRER instead of the PADER/PAER. The applicant should submit a request to FDA for each approved application for which a waiver is requested, and a single waiver request letter can include multiple applications. Waiver requests should be submitted to each of the application(s) in the request, and may be submitted electronically or by paper as described in the November 29, 2016, guidance. Each PBRER waiver request should include the following information:The product name(s) and application number(s); a brief description of the justification for the request; the U.S. approval date for the product(s) and current reporting interval used; the reporting interval of the last PADER/PAER submitted for the product(s); and the data lock point that will be used for each PBRER. If a data lock point other than one aligned to the U.S. approval date is proposed, the applicant should describe how he/she will ensure that there are no gaps in reporting intervals (e.g., by submitting overlapping reports; submitting a one-time PADER/PAER to cover the gap period; or, if the gap is less than 2 months, extending the reporting interval of the final PADER/PAER to close the gap). The frequency for submitting the PBRER, as described in section IV.C of the April 8, 2013, draft guidance. The email address and telephone number for the individual who can provide additional information regarding the waiver request. As explained earlier, existing regulations at Sec. 314.90(a) or 600.90(a) permit applicants to request waivers of any post-marketing safety reporting requirement, and the information collections associated with such waiver requests generally are approved under OMB control numbers 0910-0001 and 0910-0308. FDA believes that the information submitted under numbers 1-4 and number 7 in the list in the previous paragraph is information that is typical of any waiver request regarding post-marketing safety reporting and is accounted for in the existing approved collections of information for waiver requests and reports. Concerning numbers 5 and 6, FDA expects approximately 67 waiver requests to include the additional information for using a different data lock point and/or for using a different [[Page 37100]] reporting frequency when submitting a PBRER. FDA expects approximately 29 applicants to make these submissions, and we estimate that the time for submitting the additional information described in the previous paragraph would be on average approximately 2 hours for each waiver request. In the Federal Register of May 23, 2017 (82 FR 23578), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. No comments were received. We therefore estimate the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Additional information and/or notifications for using a Number of Number of Total annual Average burden different data lock point and/or respondents responses per responses per response Total hours a different reporting frequency respondent ---------------------------------------------------------------------------------------------------------------- Applicants that have a PSUR 55 3.4 187 1 187 waiver for an approved application.................... Applicants that do not have a 29 2.3 67 2 134 PSUR waiver for an approved application.................... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 321 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital or operating and maintenance costs associated with the information collection. Dated: August 2, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-16647 Filed 8-7-17; 8:45 am] BILLING CODE 4164-01-P
![37098 Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices
(4) Youth discussions topic guide: We perceptions of PREP-related Respondents: Grantees and their
will hold discussions with youth from programming. independent evaluators; and youth from
target populations about their target populations.
ANNUAL BURDEN ESTIMATES
Number of
Total Annual Average
responses per Annual
Instrument number of number of burden hours
respondent burden hours
respondents respondents per response
(annually)
(1) Abstract template ........................................................... 29 29 1 3 87
(2) CONSORT diagram template ........................................ 29 29 2 1 58
(3) Baseline equivalence template ...................................... 16 16 2 2 64
(4) Youth discussions topic guide ........................................ 64 21 *1 1.5 32
* Total.
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: In
Hours: 241. HUMAN SERVICES compliance with 44 U.S.C. 3507, FDA
Additional Information: Copies of the has submitted the following proposed
Food and Drug Administration collection of information to OMB for
proposed collection may be obtained by
review and clearance.
writing to the Administration for
Children and Families, Office of [Docket No. FDA–2013–D–0349] Providing Waiver-Related Materials in
Planning, Research and Evaluation, 330 Accordance With the Guidance for
Agency Information Collection
C Street SW., Washington, DC 20201, Industry on Providing Post-Market
Activities; Submission for Office of
Attn: OPRE Reports Clearance Officer. Periodic Safety Reports in the
Management and Budget Review;
All requests should be identified by the International Conference on
Comment Request; Providing Waiver- Harmonisation E2C(R2) Format
title of the information collection. Email Related Materials in Accordance With
address: OPREinfocollection@ (Periodic Benefit-Risk Evaluation
the Guidance for Industry on Providing Report); OMB Control Number 0910–
acf.hhs.gov. Post-Market Periodic Safety Reports in 0771—Extension
OMB Comment: OMB is required to the International Conference on
make a decision concerning the Harmonisation E2C(R2) Format The International Conference on
Harmonisation (ICH) of Technical
collection of information between 30 AGENCY: Food and Drug Administration, Requirements for Registration of
and 60 days after publication of this HHS. Pharmaceuticals for Human Use issued,
document in the Federal Register. on November 15, 2012, the ICH
ACTION: Notice.
Therefore, a comment is best assured of harmonized tripartite guideline entitled
having its full effect if OMB receives it SUMMARY: The Food and Drug ‘‘Periodic Benefit-Risk Evaluation
within 30 days of publication. Written Administration (FDA) is announcing Report (PBRER) E2C(R2)’’ (the PBRER
comments and recommendations for the that a proposed collection of guideline) (available at https://
proposed information collection should information has been submitted to the www.ich.org/products/guidelines/
be sent directly to the following: Office Office of Management and Budget efficacy/article/efficacy-
of Management and Budget, Paperwork (OMB) for review and clearance under guidelines.html). The PBRER guideline
Reduction Project, Email: OIRA_ the Paperwork Reduction Act of 1995. is intended to promote a consistent
SUBMISSION@OMB.EOP.GOV, Attn: DATES: Fax written comments on the approach to periodic post-marketing
Desk Officer for the Administration for collection of information by September safety reporting among the ICH regions,
Children and Families. 7, 2017. to enhance efficiency and reduce
burden by reducing the number of
Mary Jones, ADDRESSES: To ensure that comments on
reports generated for submission to the
ACF/OPRE Certifying Officer.
the information collection are received,
regulatory authorities. The PBRER is
OMB recommends that written
[FR Doc. 2017–16671 Filed 8–7–17; 8:45 am] intended to provide a common standard
comments be faxed to the Office of
BILLING CODE 4184–37–P for periodic reporting on approved
Information and Regulatory Affairs,
drugs or biologics among the ICH
OMB, Attn: FDA Desk Officer, FAX:
regions.
202–395–7285, or emailed to oira_ FDA currently has OMB approval for
submission@omb.eop.gov. All the required submission of periodic
comments should be identified with the adverse drug experience reports
OMB control number 0910–0771. Also (PADER) for drugs subject to a new drug
include the FDA docket number found application (NDA) or an abbreviated
in brackets in the heading of this
asabaliauskas on DSKBBXCHB2PROD with NOTICES
new drug application (ANDA)
document. (§ 314.80(c)(2) (21 CFR 314.80(c)(2))
FOR FURTHER INFORMATION CONTACT: (OMB control number 0910–0230), and
Domini Bean, Office of Operations, for the required submission of periodic
Food and Drug Administration, Three adverse experience reports (PAER) for
White Flint North, 10A63, 11601 drugs subject to a biologics license
Landsdown St., North Bethesda, MD application (BLA) (§ 600.80(c)(2) (21
20852, 301–796–5733, PRAStaff@ CFR 600.80(c)(2)) (OMB control number
fda.hhs.gov. 0910–0308).
VerDate Sep<11>2014 21:16 Aug 07, 2017 Jkt 241001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\08AUN1.SGM 08AUN1](https://thefederalregister.org/doc/82_FR_37249/page/1.svg)
![37100 Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices
reporting frequency when submitting a described in the previous paragraph on the proposed extension of this
PBRER. FDA expects approximately 29 would be on average approximately 2 collection of information. No comments
applicants to make these submissions, hours for each waiver request. were received.
and we estimate that the time for In the Federal Register of May 23,
We therefore estimate the burden of
submitting the additional information 2017 (82 FR 23578), we published a 60-
this collection of information as follows:
day notice requesting public comment
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Additional information and/or Number of Average
notifications for using a different data Number of Total annual
responses per burden per Total hours
lock point and/or a different reporting respondents responses
respondent response
frequency
Applicants that have a PSUR waiver for an approved ap-
plication ............................................................................ 55 3.4 187 1 187
Applicants that do not have a PSUR waiver for an ap-
proved application ............................................................ 29 2.3 67 2 134
Total .............................................................................. ........................ ........................ ........................ ........................ 321
1 There are no capital or operating and maintenance costs associated with the information collection.
Dated: August 2, 2017. comments be faxed to the Office of 371, and 374) and sections 4 and 5 of
Anna K. Abram, Information and Regulatory Affairs, the FPLA (15 U.S.C. 1453 and 1454)
Deputy Commissioner for Policy, Planning, OMB, Attn: FDA Desk Officer, FAX: provide authority to FDA to regulate the
Legislation, and Analysis. 202–395–7285, or emailed to oira_ labeling of cosmetic products. Failure to
[FR Doc. 2017–16647 Filed 8–7–17; 8:45 am] submission@omb.eop.gov. All comply with the requirements for
BILLING CODE 4164–01–P comments should be identified with the cosmetic labeling may render a cosmetic
OMB control number 0910–0599. Also adulterated under section 601 of the
include the FDA docket number found FD&C Act or misbranded under section
DEPARTMENT OF HEALTH AND in brackets in the heading of this 602 of the FD&C Act.
HUMAN SERVICES document. FDA’s cosmetic labeling regulations
FOR FURTHER INFORMATION CONTACT: Ila are published in part 701 (21 CFR part
Food and Drug Administration 701). Four of the cosmetic labeling
S. Mizrachi, Office of Operations, Food
[Docket No. FDA–2017–N–1848] and Drug Administration, Three White regulations have information collection
Flint North, 10A63, 11601 Landsdown provisions. Section 701.3 requires the
Agency Information Collection label of a cosmetic product to bear a
Activities; Submission for Office of St., North Bethesda, MD 20852, 301–
796–7726, PRAStaff@fda.hhs.gov. declaration of the ingredients in
Management and Budget Review; descending order of predominance.
Comment Request; Cosmetic Labeling SUPPLEMENTARY INFORMATION: In Section 701.11 requires the principal
Regulations compliance with 44 U.S.C. 3507, FDA display panel of a cosmetic product to
has submitted the following proposed bear a statement of the identity of the
AGENCY: Food and Drug Administration, collection of information to OMB for
HHS. product. Section 701.12 requires the
review and clearance. label of a cosmetic product to specify
ACTION: Notice.
Cosmetic Labeling Regulations—21 CFR the name and place of business of the
SUMMARY: The Food and Drug Part 701 manufacturer, packer, or distributor.
Administration (FDA, the Agency, or Section 701.13 requires the label of a
we) is announcing that a proposed OMB Control Number 0910–0599— cosmetic product to declare the net
collection of information has been Extension quantity of contents of the product.
submitted to the Office of Management The Federal Food, Drug, and Cosmetic In the Federal Register of May 23,
and Budget (OMB) for review and Act (the FD&C Act) and the Fair 2017 (82 FR 23576), FDA published a
clearance under the Paperwork Packaging and Labeling Act (the FPLA) 60-day notice requesting public
Reduction Act of 1995 (PRA). require that cosmetic manufacturers, comment on the proposed collection of
DATES: Fax written comments on the packers, and distributors disclose information. One comment was received
collection of information by September information about themselves or their which described ingredients used in the
7, 2017. products on the labels or labeling of creation of cosmetics but was not PRA-
ADDRESSES: To ensure that comments on their products. Sections 201, 301, 502, related and will not be addressed here.
the information collection are received, 601, 602, 603, 701, and 704 of the FD&C FDA estimates the burden of this
OMB recommends that written Act (21 U.S.C. 321, 352, 361, 362, 363, collection of information as follows:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
21 CFR section/activity burden per Total hours
respondents per disclosures disclosure
respondent
701.3—Ingredients in order of predominance ..................... 1,518 21 31,878 1 31,878
701.11—Statement of identity ............................................. 1,518 24 36,432 1 36,432
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Document Created: 2017-08-08 00:17:24
Document Modified: 2017-08-08 00:17:24
| 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 | Fax written comments on the collection of information by September 7, 2017. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 82 FR 37098 |
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