83 FR 13990 - Food and Drug Administration Prescription Drug User Fee Act VI Benefit-Risk Implementation Plan; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 63 (April 2, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 63 (April 2, 2018)
| Page Range | 13990-13992 | |
| FR Document | 2018-06531 |
[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)] [Notices] [Pages 13990-13992] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06531] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1010] Food and Drug Administration Prescription Drug User Fee Act VI Benefit-Risk Implementation Plan; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft 5-year plan describing the Agency's approach to further the implementation of structured benefit-risk assessment, including the incorporation of the patient's voice in drug development and decision-making, in the human drug review program and the opportunity for public comment on the draft plan. This new draft plan is an update to the 5-year plan published in February 2013 on FDA's website. This new draft plan is [[Page 13991]] part of FDA's commitments that were made as part of the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI). FDA has published the draft plan on its website. DATES: Submit either electronic or written comments by June 1, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 1, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of June 1, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2018-N-1010 for ``Food and Drug Administration Prescription Drug User Fee Act VI Benefit-Risk Implementation Plan; Request for Comments.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 301- 796-5003, Fax: 301-847-8443, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft 5-year plan describing the Agency's approach to further the implementation of structured benefit-risk assessment into human drug and biologics review. This draft plan is intended to meet a performance goal included in the sixth authorization of PDUFA (PDUFA VI). This reauthorization, part of the FDA Reauthorization Act of 2017 signed by the President on August 18, 2017, includes a number of performance goals and procedures that are documented in the PDUFA VI Commitment Letter, which is available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf. This new draft plan is an update to the 5-year plan published in February 2013 on FDA's website: https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf. FDA's commitments to meet certain performance goals under PDUFA VI were developed in consultation with patient and consumer advocates, health care professionals, and other public stakeholders, as part of negotiations with regulated industry. Section J.2 of the commitment letter, ``Enhancing Benefit-Risk Assessment in Regulatory Decision- Making'' (https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf) outlines FDA's commitments in this area, including publication of an update to the implementation plan published in 2013 entitled ``Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making'' (https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf). The update includes a report on the progress made during PDUFA V and a plan for continued implementation during Fiscal Years (FY) 2018-2022. The publication and implementation of this plan are intended to fulfill the commitments described in Section J of the PDUFA VI Commitment Letter. II. FDA Draft PDUFA VI Benefit-Risk Implementation Plan Benefit-risk assessment is the foundation for FDA's regulatory review of human drugs and biologics. In PDUFA V, FDA's Center for Drug [[Page 13992]] Evaluation and Research and Center for Biologics and Research committed to further our efforts to enhance benefit-risk assessment and communication in the human drug review process in FY 2013-2017. Enhancing and communicating benefit-risk assessment continues to be an Agency priority in PDUFA VI. The draft plan describes the progress made on PDUFA V in benefit-risk assessment. This progress includes revision of FDA's review/decision templates and manuals to incorporate FDA's approach to benefit-risk assessment, training review and management of staff on the revised templates and manuals, developing an evaluation plan to ascertain the impact of FDA's implementation of the Benefit- Risk Framework in drug review, holding two public workshops on benefit- risk considerations from the regulator's perspective, and advancing FDA's Patient-Focused Drug Development initiative. This draft plan also summarizes the third-party evaluation of FDA's implementation of the Benefit-Risk Framework into FDA's new drug review. The plan also includes an overview of FDA's commitments in PDUFA VI for continued implementation of structured benefit-risk assessment during FY 2018-2022. These commitments include participating in a meeting to gather stakeholder input on key topics, publishing a draft guidance on benefit-risk assessment for new drugs and biologics, continuing to revise relevant Manuals for Policies and Procedures and Standard Operating Practices and Procedures to incorporate benefit-risk assessment approaches, and conducting a second evaluation of the implementation of the Benefit-Risk Framework beginning in 2021. In addition to these commitments, FDA also plans to explore additional opportunities to enhance our use and communication of benefit-risk assessments. III. Electronic Access FDA has published the draft plan on its website: https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm. The period for public comment on the draft plan will remain open for 60 days following the publication of this notice. After consideration of public comments, FDA will finalize the plan. Throughout PDUFA VI, the Agency will update the plan as necessary and post all updates on FDA's website. Dated: March 22, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-06531 Filed 3-30-18; 8:45 am] BILLING CODE 4164-01-P
![13990 Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
Reductions in data elements are found into two types: (1) Case management, always a cost to changing data systems,
throughout the data collection but are and (2) information and assistance. Case but believes that the anticipated
concentrated in the consumer management assistance services are improvement in the data justifies the
demographic components. Due to the categorized as registered, meaning proposed changes,
aggregate level nature of the SPR, caregiver demographic data are reported • New items related to Legal Services-
information on combinations of while information and assistance ACL worked closely with program staff
demographic characteristics (e.g., services do not include reporting of and stakeholders to develop a
number of women served who are 65 demographic data. Supplemental reasonable data collection to measure
years or older and have 2 activity of services are reported in the same the contribution of this important
daily living limitations) require manner as ‘‘other service’’ under Title program about which performance data
exponentially larger numbers of data III–B, Home and Community-based were not previously collected,
elements compared to single Services (HCBS) program. Across the • Need for additional elements
demographic characteristics (e.g. OAA services, greater detail regarding including sub-state and individual level
number of women served). To reduce expenditure data is proposed. Under data-ACL is not adding more elements
the reporting burden associated with the Title III–B, HCBS program, the proposed or more granular data collection at this
number of data elements ACL is data collection expands data regarding time but will consider those suggestions
proposing to limit data element Title VII legal assistance services. The for future data collections,
combinations. For example, the revised ACL seeks data on the OAA identified • Need for improved definitions and
SPR asks for demographic characteristic priority legal issues for closed cases. language-ACL made several changes to
such as age, race, and gender for three
Comments in Response to the 60-Day specific elements and is using these
or more ADL and IADLs rather than for
Federal Register Notice comments to inform the training and
zero, one, two and three or more ADLs
technical assistance it provides, and
and IADLs. The remaining proposed A 60-day Federal Register Notice was
demographic data elements include • Caregiver program-ACL made
published in the Federal Register on
indicators of priority populations (i.e., revisions to several items and is using
June 1, 2017, Vol. 82, No. 104, pp.
social and economic vulnerability and these comments to inform the training
25293–25294.
frailty) found in the OAA and will allow ACL received comments from and technical assistance it provides.
ACL to continue to measure efforts to fourteen (14) organizations and one (1) A detailed analysis of the comments
target services. individual about the State Performance and responses can be found at (https://
Limited expansions in data elements Report (SPR) redesign. ACL reviewed all www.reginfo.gov/public/do/PRAMain.
are found in the Title III–E National of the comments, but some of the The proposed data collection template
Family Caregiver Support Program comments were deemed not relevant may be found on the ACL website at
service component. The proposal because they were: (a) About the data https://www.acl.gov/about-acl/public-
separates out three service areas that submission process itself (b) did not input.
were reported as a whole (i.e., request a change (c) only commented on Estimated Program Burden: ACL
counseling, training and support group the format (d) indicated topics for estimates the burden of this collection
services). Separation allows for support technical assistance and training for the of information as follows: 56 State
group services to be categorized as a final data collection or (e) provided Agencies on Aging respond annually
non-registered service for which commentary without referencing the and it will take an average of 33.5 hours
consumer demographic details are no SPR. Regarding concerns about the: for a total of 1,876 hours. This is a
longer reported. Additional information • Timeline-ACL proposes moving the reduction of 874 hours from the
regarding the types of respite services effective date back by 12 months, previous version. The burden estimate
provided under the OAA is sought. The • Cost, burden, and changes to data of 33.5 hours was derived from feedback
proposal separates assistance services elements-ACL recognizes that there is from grantees.
Responses
Number of Hours per Annual burden
Respondent/data collection activity per
respondents response hours
respondent
Older American Act Title III and Title VII (Chapters 3 and 4) Annual State
Program Reporting ....................................................................................... 56 1 33.5 1,876
Total .......................................................................................................... 56 1 33.5 1,876
Dated: March 26, 2018. DEPARTMENT OF HEALTH AND SUMMARY: The Food and Drug
Mary Lazare, HUMAN SERVICES Administration (FDA or Agency) is
Principal Deputy Administrator. announcing the availability of a draft 5-
Food and Drug Administration year plan describing the Agency’s
[FR Doc. 2018–06662 Filed 3–30–18; 8:45 am]
BILLING CODE 4154–01–P [Docket No. FDA–2018–N–1010] approach to further the implementation
of structured benefit-risk assessment,
Food and Drug Administration including the incorporation of the
daltland on DSKBBV9HB2PROD with NOTICES
Prescription Drug User Fee Act VI patient’s voice in drug development and
Benefit-Risk Implementation Plan; decision-making, in the human drug
Request for Comments review program and the opportunity for
AGENCY: Food and Drug Administration, public comment on the draft plan. This
HHS. new draft plan is an update to the 5-year
plan published in February 2013 on
ACTION: Notice; request for comments.
FDA’s website. This new draft plan is
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![13992 Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
Evaluation and Research and Center for Dated: March 22, 2018. comment will be made public, you are
Biologics and Research committed to Leslie Kux, solely responsible for ensuring that your
further our efforts to enhance benefit- Associate Commissioner for Policy. comment does not include any
risk assessment and communication in [FR Doc. 2018–06531 Filed 3–30–18; 8:45 am] confidential information that you or a
the human drug review process in FY BILLING CODE 4164–01–P third party may not wish to be posted,
2013–2017. Enhancing and such as medical information, your or
communicating benefit-risk assessment anyone else’s Social Security number, or
continues to be an Agency priority in DEPARTMENT OF HEALTH AND confidential business information, such
PDUFA VI. The draft plan describes the HUMAN SERVICES as a manufacturing process. Please note
that if you include your name, contact
progress made on PDUFA V in benefit-
Food and Drug Administration information, or other information that
risk assessment. This progress includes
[Docket No. FDA–2012–N–0369] identifies you in the body of your
revision of FDA’s review/decision comments, that information will be
templates and manuals to incorporate posted on https://www.regulations.gov.
Agency Information Collection
FDA’s approach to benefit-risk • If you want to submit a comment
Activities; Proposed Collection;
assessment, training review and with confidential information that you
Comment Request; Regulations Under
management of staff on the revised the Federal Import Milk Act do not wish to be made available to the
templates and manuals, developing an public, submit the comment as a
evaluation plan to ascertain the impact AGENCY: Food and Drug Administration, written/paper submission and in the
of FDA’s implementation of the Benefit- HHS. manner detailed (see ‘‘Written/Paper
Risk Framework in drug review, holding ACTION: Notice. Submissions’’ and ‘‘Instructions’’).
two public workshops on benefit-risk Written/Paper Submissions
SUMMARY: The Food and Drug
considerations from the regulator’s Administration (FDA or Agency) is
perspective, and advancing FDA’s Submit written/paper submissions as
announcing an opportunity for public follows:
Patient-Focused Drug Development comment on the proposed collection of • Mail/Hand Delivery/Courier (for
initiative. This draft plan also certain information by the Agency. written/paper submissions): Dockets
summarizes the third-party evaluation Under the Paperwork Reduction Act of Management Staff (HFA–305), Food and
of FDA’s implementation of the Benefit- 1995 (PRA), Federal Agencies are Drug Administration, 5630 Fishers
Risk Framework into FDA’s new drug required to publish notice in the Lane, Rm. 1061, Rockville, MD 20852.
review. Federal Register concerning each • For written/paper comments
The plan also includes an overview of proposed collection of information, submitted to the Dockets Management
FDA’s commitments in PDUFA VI for including each proposed extension of an Staff, FDA will post your comment, as
continued implementation of structured existing collection of information, and well as any attachments, except for
benefit-risk assessment during FY 2018– to allow 60 days for public comment in information submitted, marked and
2022. These commitments include response to the notice. This notice identified, as confidential, if submitted
participating in a meeting to gather solicits comments on the reporting and as detailed in ‘‘Instructions.’’
recordkeeping requirements of our Instructions: All submissions received
stakeholder input on key topics,
regulations implementing the Federal must include the Docket No. FDA–
publishing a draft guidance on benefit-
Import Milk Act (FIMA). 2012–N–0369 for ‘‘Agency Information
risk assessment for new drugs and
DATES: Submit either electronic or Collection Activities; Proposed
biologics, continuing to revise relevant
written comments on the collection of Collection; Comment Request;
Manuals for Policies and Procedures Regulations under the Federal Import
information by June 1, 2018.
and Standard Operating Practices and Milk Act.’’ Received comments, those
ADDRESSES: You may submit comments
Procedures to incorporate benefit-risk filed in a timely manner (see
as follows: Please note that late,
assessment approaches, and conducting ADDRESSES), will be placed in the docket
untimely filed comments will not be
a second evaluation of the and, except for those submitted as
considered. Electronic comments must
implementation of the Benefit-Risk be submitted on or before June 1, 2018. ‘‘Confidential Submissions,’’ publicly
Framework beginning in 2021. In The https://www.regulations.gov viewable at https://www.regulations.gov
addition to these commitments, FDA electronic filing system will accept or at the Dockets Management Staff
also plans to explore additional comments until midnight Eastern Time between 9 a.m. and 4 p.m., Monday
opportunities to enhance our use and at the end of June 1, 2018. Comments through Friday.
communication of benefit-risk received by mail/hand delivery/courier • Confidential Submissions—To
assessments. (for written/paper submissions) will be submit a comment with confidential
considered timely if they are information that you do not wish to be
III. Electronic Access made publicly available, submit your
postmarked or the delivery service
FDA has published the draft plan on acceptance receipt is on or before that comments only as a written/paper
its website: https://www.fda.gov/ date. submission. You should submit two
copies total. One copy will include the
ForIndustry/UserFees/Prescription Electronic Submissions information you claim to be confidential
DrugUserFee/ucm326192.htm. The
Submit electronic comments in the with a heading or cover note that states
period for public comment on the draft ‘‘THIS DOCUMENT CONTAINS
following way:
daltland on DSKBBV9HB2PROD with NOTICES
plan will remain open for 60 days • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
following the publication of this notice. https://www.regulations.gov. Follow the Agency will review this copy, including
After consideration of public comments, instructions for submitting comments. the claimed confidential information, in
FDA will finalize the plan. Throughout Comments submitted electronically, its consideration of comments. The
PDUFA VI, the Agency will update the including attachments, to https:// second copy, which will have the
plan as necessary and post all updates www.regulations.gov will be posted to claimed confidential information
on FDA’s website. the docket unchanged. Because your redacted/blacked out, will be available
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Document Created: 2018-11-01 09:09:02
Document Modified: 2018-11-01 09:09:02
| 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; request for comments. | |
| Dates | Submit either electronic or written comments by June 1, 2018. | |
| Contact | Graham Thompson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 301- 796-5003, Fax: 301-847-8443, [email protected] | |
| FR Citation | 83 FR 13990 |
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