83 FR 63178 - Framework for a Real-World Evidence Program; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 235 (December 7, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 235 (December 7, 2018)
| Page Range | 63178-63179 | |
| FR Document | 2018-26546 |
[Federal Register Volume 83, Number 235 (Friday, December 7, 2018)] [Notices] [Pages 63178-63179] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26546] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-4000] Framework for a Real-World Evidence Program; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect comments on a framework created by the Center for Drug Evaluation and Research and the Center for Biologic Evaluation and Research for implementing a program to evaluate the potential use of real-world evidence (RWE) in regulatory decision making. This framework is entitled ``Framework for the Real-World Evidence Program.'' The 21st Century Cures Act (Cures Act) was enacted on December 13, 2016, and requires that FDA establish a framework for implementing a program to evaluate the potential use of RWE to help support the approval of a new indication for a drug approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to help support or satisfy postapproval study requirements. FDA has created this framework to satisfy the Cures Act mandate and is establishing a docket to receive public comments. DATES: Submit either electronic or written comments on the draft document by February 5, 2019 to ensure that the Agency considers your comment before it begins work to implement the program. 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: [[Page 63179]] 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-4000 for ``Framework for a Real-World Evidence Program; Availability.'' 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 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: Dianne Paraoan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3326, Silver Spring, MD 20993-0002, 301- 796-2500, [email protected]; 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, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is establishing a public docket to collect comments on its ``Framework for a Real-World Evidence Program.'' Section 3022 of the Cures Act amended the FD&C Act to add section 505F, Utilizing real world evidence (21 U.S.C. 355g). This section requires the establishment of a program to evaluate the potential use of RWE to help support the approval of a new indication for a drug approved under section 505(c) of the FD&C Act (21 U.S.C. 355(c)) and to help to support or satisfy postapproval study requirements. This section also requires FDA publish a framework for that program. In addition to drug and biological products approved under section 505(c) of the FD&C Act, FDA is also applying this framework to biological products licensed under section 351 of the Public Health Service Act (42 U.S.C. 262). The statute directs that the framework for the RWE program include information describing sources of RWE, gaps in data collection activities, standards and methodologies for collecting and analyzing RWE, and priority areas, remaining challenges, and potential pilot opportunities to address the overarching Cures Act requirements. To help meet a requirement in the Cures Act for consultation in developing the program framework, on September 13, 2017, through its cooperative agreement with the Duke Margolis Center for Health Policy, FDA convened a public meeting that explored the use of RWE for regulatory decisions. Representatives from industry, academia, and patient advocacy groups discussed, among other things, opportunities and challenges associated with applying real-world data and RWE, the evidence derived from that data, to demonstrate product effectiveness, including data acquisition, study design, and analytic methods necessary to establish causal inference. The workshop helped to inform FDA's RWE framework. FDA will continue to consult stakeholders through public-private partnerships, public workshops, and demonstration projects as it implements its RWE program. II. Electronic Access Persons with access to the internet may obtain the ``Framework for the Real-World Evidence Program'' at https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/21stCenturyCuresAct/ucm562475.htm. Dated: November 30, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-26546 Filed 12-6-18; 8:45 am] BILLING CODE 4164-01-P
![63178 Federal Register / Vol. 83, No. 235 / Friday, December 7, 2018 / Notices
collection, which is being conducted to FDA estimates the burden of this
evaluate the campaign. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Respondent type and activity responses per burden per Total hours
respondents responses
respondent response
Venue Owners and Managers ............................ 660 1 660 0.083 (5 minutes) ........... 55
General Population: Pilot test of Procedures in 27 1 27 0.083 (5 minutes) ........... 2
Bars.
General population—outcome screener (in per- 11,239 1 11,239 0.083 (5 minutes) ........... 933
son).
General population—outcome screener (social 3,539 1 3,539 0.083 (5 minutes) ........... 294
media).
LGBT young adults outcome baseline (social 263 1 263 0.5 (30 minutes) ............. 132
media).
LGBT young adults outcome baseline (in per- 788 1 788 0.5 (30 minutes) ............. 394
son).
LGBT young adults outcome followup question- 1,752 1 1,752 0.667 (40 minutes) ......... 1,169
naire (social media).
LGBT young adults outcome followup question- 5,378 1 5,378 0.667 (40 minutes) ......... 3,587
naire (in person).
Totals ............................................................ ........................ ........................ ........................ ........................................ 6,566
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
To accommodate the additional waves DEPARTMENT OF HEALTH AND that the Agency considers your
of data collection, FDA requests HUMAN SERVICES comment before it begins work to
approval to increase the number of implement the program.
burden hours under the existing control Food and Drug Administration
ADDRESSES: You may submit comments
number. The previous number of [Docket No. FDA–2018–N–4000] as follows:
approved responses was 53,967 (17,989
annualized), and the previous burden Framework for a Real-World Evidence Electronic Submissions
was 14,031 hours (4,677 annualized). Program; Availability Submit electronic comments in the
The fifth and sixth followups add AGENCY: Food and Drug Administration, following way:
23,478 responses (7,826 annualized), HHS. • Federal eRulemaking Portal:
which include responses to new venues ACTION: Notice of availability. https://www.regulations.gov. Follow the
assessments, screening questionnaires, instructions for submitting comments.
and the followup questionnaires, for a SUMMARY: The Food and Drug Comments submitted electronically,
total of 7,074 additional burden hours Administration (FDA or Agency) is including attachments, to https://
(2,357 annualized). Removing the media establishing a public docket to collect www.regulations.gov will be posted to
tracking component deducts 6,507 comments on a framework created by the docket unchanged. Because your
responses (2,169 annualized) and 1,413 the Center for Drug Evaluation and comment will be made public, you are
burden hours (471 annualized). The Research and the Center for Biologic solely responsible for ensuring that your
totals for the entire evaluation study are Evaluation and Research for comment does not include any
implementing a program to evaluate the confidential information that you or a
increasing by 16,971 responses (5,657
potential use of real-world evidence third party may not wish to be posted,
annualized) and 5,661 hours (1,887
(RWE) in regulatory decision making. such as medical information, your or
annualized) for a new total of 70,938
This framework is entitled ‘‘Framework anyone else’s Social Security number, or
responses (23,646 annualized) and for the Real-World Evidence Program.’’ confidential business information, such
19,692 burden hours (approximately The 21st Century Cures Act (Cures Act) as a manufacturing process. Please note
6,566 annualized). was enacted on December 13, 2016, and that if you include your name, contact
Dated: November 30, 2018. requires that FDA establish a framework information, or other information that
Leslie Kux, for implementing a program to evaluate identifies you in the body of your
Associate Commissioner for Policy.
the potential use of RWE to help comments, that information will be
support the approval of a new posted on https://www.regulations.gov.
[FR Doc. 2018–26555 Filed 12–6–18; 8:45 am]
indication for a drug approved under • If you want to submit a comment
BILLING CODE 4164–01–P
the Federal Food, Drug, and Cosmetic with confidential information that you
Act (FD&C Act) and to help support or do not wish to be made available to the
satisfy postapproval study requirements. public, submit the comment as a
amozie on DSK3GDR082PROD with NOTICES
FDA has created this framework to written/paper submission and in the
satisfy the Cures Act mandate and is manner detailed (see ‘‘Written/Paper
establishing a docket to receive public Submissions’’ and ‘‘Instructions’’).
comments.
Written/Paper Submissions
DATES: Submit either electronic or
written comments on the draft Submit written/paper submissions as
document by February 5, 2019 to ensure follows:
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![Federal Register / Vol. 83, No. 235 / Friday, December 7, 2018 / Notices 63179
• Mail/Hand Delivery/Courier (for Staff, 5630 Fishers Lane, Rm. 1061, inform FDA’s RWE framework. FDA
written/paper submissions): Dockets Rockville, MD 20852. will continue to consult stakeholders
Management Staff (HFA–305), Food and FOR FURTHER INFORMATION CONTACT: through public-private partnerships,
Drug Administration, 5630 Fishers Dianne Paraoan, Center for Drug public workshops, and demonstration
Lane, Rm. 1061, Rockville, MD 20852. Evaluation and Research, Food and projects as it implements its RWE
• For written/paper comments Drug Administration, 10903 New program.
submitted to the Dockets Management Hampshire Ave., Bldg. 51, Rm. 3326,
Staff, FDA will post your comment, as II. Electronic Access
Silver Spring, MD 20993–0002, 301–
well as any attachments, except for 796–2500, dianne.paraoan@fda.hhs.gov; Persons with access to the internet
information submitted, marked and or Stephen Ripley, Center for Biologics may obtain the ‘‘Framework for the
identified, as confidential, if submitted Evaluation and Research, Food and Real-World Evidence Program’’ at
as detailed in ‘‘Instructions.’’ Drug Administration, 10903 New https://www.fda.gov/
Instructions: All submissions received Hampshire Ave., Bldg. 71, Rm. 7301, RegulatoryInformation/LawsEnfor
must include the Docket No. FDA– Silver Spring, MD 20993–0002, 240– cedbyFDA/SignificantAmendmentsto
2018–N–4000 for ‘‘Framework for a 402–7911, stephen.ripley@fda.hhs.gov. theFDCAct/21stCenturyCuresAct/
Real-World Evidence Program; ucm562475.htm.
Availability.’’ Received comments will SUPPLEMENTARY INFORMATION:
Dated: November 30, 2018.
be placed in the docket and, except for I. Background
those submitted as ‘‘Confidential Leslie Kux,
Submissions,’’ publicly viewable at FDA is establishing a public docket to Associate Commissioner for Policy.
https://www.regulations.gov or at the collect comments on its ‘‘Framework for [FR Doc. 2018–26546 Filed 12–6–18; 8:45 am]
Dockets Management Staff between 9 a Real-World Evidence Program.’’ BILLING CODE 4164–01–P
a.m. and 4 p.m., Monday through Section 3022 of the Cures Act amended
Friday. the FD&C Act to add section 505F,
• Confidential Submissions—To Utilizing real world evidence (21 U.S.C. DEPARTMENT OF HEALTH AND
submit a comment with confidential 355g). This section requires the HUMAN SERVICES
information that you do not wish to be establishment of a program to evaluate
made publicly available, submit your the potential use of RWE to help Food and Drug Administration
comments only as a written/paper support the approval of a new
indication for a drug approved under [Docket No. FDA–2012–N–0961]
submission. You should submit two
copies total. One copy will include the section 505(c) of the FD&C Act (21
U.S.C. 355(c)) and to help to support or Agency Information Collection
information you claim to be confidential Activities; Submission for Office of
with a heading or cover note that states satisfy postapproval study requirements.
This section also requires FDA publish Management and Budget Review;
‘‘THIS DOCUMENT CONTAINS Comment Request; Environmental
CONFIDENTIAL INFORMATION.’’ The a framework for that program. In
addition to drug and biological products Impact Considerations
Agency will review this copy, including
the claimed confidential information, in approved under section 505(c) of the AGENCY: Food and Drug Administration,
its consideration of comments. The FD&C Act, FDA is also applying this HHS.
second copy, which will have the framework to biological products
ACTION: Notice.
claimed confidential information licensed under section 351 of the Public
redacted/blacked out, will be available Health Service Act (42 U.S.C. 262). SUMMARY: The Food and Drug
for public viewing and posted on The statute directs that the framework Administration (FDA) is announcing
https://www.regulations.gov. Submit for the RWE program include that a proposed collection of
both copies to the Dockets Management information describing sources of RWE, information has been submitted to the
Staff. If you do not wish your name and gaps in data collection activities, Office of Management and Budget
contact information to be made publicly standards and methodologies for (OMB) for review and clearance under
available, you can provide this collecting and analyzing RWE, and the Paperwork Reduction Act of 1995.
information on the cover sheet and not priority areas, remaining challenges, DATES: Fax written comments on the
in the body of your comments and you and potential pilot opportunities to collection of information by January 7,
must identify this information as address the overarching Cures Act 2019.
‘‘confidential.’’ Any information marked requirements. To help meet a
ADDRESSES: To ensure that comments on
as ‘‘confidential’’ will not be disclosed requirement in the Cures Act for
consultation in developing the program the information collection are received,
except in accordance with 21 CFR 10.20
framework, on September 13, 2017, OMB recommends that written
and other applicable disclosure law. For
through its cooperative agreement with comments be faxed to the Office of
more information about FDA’s posting
the Duke Margolis Center for Health Information and Regulatory Affairs,
of comments to public dockets, see 80
Policy, FDA convened a public meeting OMB, Attn: FDA Desk Officer, Fax: 202–
FR 56469, September 18, 2015, or access
that explored the use of RWE for 395–7285, or emailed to oira_
the information at: https://www.gpo.gov/
regulatory decisions. Representatives submission@omb.eop.gov. All
fdsys/pkg/FR-2015-09-18/pdf/2015-
from industry, academia, and patient comments should be identified with the
23389.pdf.
Docket: For access to the docket to advocacy groups discussed, among OMB control number 0910–0322. Also
read background documents or the other things, opportunities and include the FDA docket number found
in brackets in the heading of this
amozie on DSK3GDR082PROD with NOTICES
electronic and written/paper comments challenges associated with applying
received, go to https:// real-world data and RWE, the evidence document.
www.regulations.gov and insert the derived from that data, to demonstrate FOR FURTHER INFORMATION CONTACT:
docket number, found in brackets in the product effectiveness, including data Amber Sanford, Office of Operations,
heading of this document, into the acquisition, study design, and analytic Food and Drug Administration, Three
‘‘Search’’ box and follow the prompts methods necessary to establish causal White Flint North, 10A–12M, 11601
and/or go to the Dockets Management inference. The workshop helped to Landsdown St., North Bethesda, MD
VerDate Sep<11>2014 16:56 Dec 06, 2018 Jkt 247001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\07DEN1.SGM 07DEN1](https://thefederalregister.org/doc/83_FR_63413/page/2.svg)
Document Created: 2018-12-07 01:53:08
Document Modified: 2018-12-07 01:53:08
| 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 draft document by February 5, 2019 to ensure that the Agency considers your comment before it begins work to implement the program. | |
| Contact | Dianne Paraoan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3326, Silver Spring, MD 20993-0002, 301- 796-2500, [email protected]; 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, [email protected] | |
| FR Citation | 83 FR 63178 |
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