83 FR 25465 - Waivers of the Single, Shared System Risk Evaluation and Mitigation Strategy Requirement; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 106 (June 1, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 106 (June 1, 2018)
| Page Range | 25465-25466 | |
| FR Document | 2018-11784 |
[Federal Register Volume 83, Number 106 (Friday, June 1, 2018)] [Notices] [Pages 25465-25466] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-11784] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-1043] Waivers of the Single, Shared System Risk Evaluation and Mitigation Strategy Requirement; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Waivers of the Single, Shared System REMS Requirement.'' This guidance describes how FDA intends to consider granting a waiver of the requirement in the Federal Food, Drug, and Cosmetic Act (FD&C Act) that the applicant for an abbreviated new drug application (ANDA) and its reference listed drug (RLD) use a single, shared system (SSS) for a required risk evaluation and mitigation strategy (REMS) with elements to assure safe use (ETASU). DATES: Submit either electronic or written comments on the draft guidance by August 30, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): 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-D-1043 for ``Waivers of the Single, Shared System Risk Evaluation and Mitigation Strategy Requirement; Draft Guidance for Industry; 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, 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. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Elaine Lippmann, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6238, Silver Spring, MD 20993, 301-796- [[Page 25466]] 3600, [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. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Waivers of the Single, Shared System REMS Requirement.'' This guidance describes how the Agency intends to consider granting a waiver of the requirement in section 505-1(i) of the FD&C Act (21 U.S.C. 355-1(i)) that the applicant for an ANDA and its RLD use a SSS for a required REMS with ETASU. Section 505-l(i)(l)(B) of the FD&C Act requires that a holder of an ANDA under section 505(j) use a ``single, shared system'' with the RLD for any ETASU, unless FDA waives this requirement. The statute permits a waiver of the SSS requirement if FDA finds that (1) ``the burden of creating a [SSS] outweighs the benefit of a single, system, taking into consideration the impact on health care providers, patients, the applicant for the [ANDA], and the holder of the reference drug product,'' or (2) an aspect of the ETASU for the applicable listed drug is claimed by an unexpired patent or trade secret and the ANDA applicant certifies that it sought a license for use of the aspect, but was unable to obtain one. If a waiver of the SSS requirement is granted, the ANDA may use ``a different, comparable aspect of the [ETASU],'' instead of participating in a SSS with the RLD. This guidance is intended to explain the factors FDA will consider in evaluating a request for waiver of the SSS requirement and provide recommendations to ANDA applicants regarding the submission and content of waiver requests. The guidance also addresses FDA's interpretation of what constitutes a different, comparable aspect of the ETASU as described in section 505-1(i)(1)(B). This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ``Waivers of the Single, Shared System REMS Requirement.'' It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This draft guidance refers to collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The preparation and submission of waiver requests (as described in 21 CFR 314.90 for new drug application applicants and 314.99(b) for ANDA applicants) has been approved under OMB control number 0910-0001. In accordance with the PRA, before publication of the final guidance document, FDA intends to solicit public comment and obtain OMB approval for any information collections recommended in this guidance that are new or that would represent material modifications to previously approved collections of information found in FDA regulations. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.regulations.gov. Dated: May 24, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-11784 Filed 5-31-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 106 / Friday, June 1, 2018 / Notices 25465
requests should be identified by the title Electronic Submissions information you claim to be confidential
of the information collection. Submit electronic comments in the with a heading or cover note that states
The Department specifically requests following way: ‘‘THIS DOCUMENT CONTAINS
comments on: (a) Whether the proposed • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
collection of information is necessary https://www.regulations.gov. Follow the Agency will review this copy, including
for the proper performance of the instructions for submitting comments. the claimed confidential information, in
functions of the agency, including Comments submitted electronically, its consideration of comments. The
whether the information shall have including attachments, to https:// second copy, which will have the
practical utility; (b) the accuracy of the www.regulations.gov will be posted to claimed confidential information
agency’s estimate of the burden of the the docket unchanged. Because your redacted/blacked out, will be available
proposed collection of information; (c) comment will be made public, you are for public viewing and posted on
the quality, utility, and clarity of the solely responsible for ensuring that your https://www.regulations.gov. Submit
information to be collected; and (d) comment does not include any both copies to the Dockets Management
ways to minimize the burden of the confidential information that you or a Staff. If you do not wish your name and
collection of information on third party may not wish to be posted, contact information to be made publicly
respondents, including through the use such as medical information, your or available, you can provide this
of automated collection techniques or anyone else’s Social Security number, or information on the cover sheet and not
other forms of information technology. confidential business information, such in the body of your comments and you
Consideration will be given to as a manufacturing process. Please note must identify this information as
comments and suggestions submitted that if you include your name, contact ‘‘confidential.’’ Any information marked
within 60 days of this publication. information, or other information that as ‘‘confidential’’ will not be disclosed
identifies you in the body of your except in accordance with 21 CFR 10.20
Robert A. Sargis, and other applicable disclosure law. For
Reports Clearance Officer. comments, that information will be
posted on https://www.regulations.gov. more information about FDA’s posting
[FR Doc. 2018–11796 Filed 5–31–18; 8:45 am] of comments to public dockets, see 80
• If you want to submit a comment
BILLING CODE 4184–34–P
with confidential information that you FR 56469, September 18, 2015, or access
do not wish to be made available to the the information at: https://www.gpo.gov/
public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
DEPARTMENT OF HEALTH AND 23389.pdf.
HUMAN SERVICES written/paper submission and in the
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’). read background documents or the
Food and Drug Administration electronic and written/paper comments
Written/Paper Submissions received, go to https://
[Docket No. FDA–2018–D–1043] www.regulations.gov and insert the
Submit written/paper submissions as
follows: docket number, found in brackets in the
Waivers of the Single, Shared System
Risk Evaluation and Mitigation • Mail/Hand delivery/Courier (for heading of this document, into the
written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
Strategy Requirement; Draft Guidance and/or go to the Dockets Management
for Industry; Availability Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
HHS. • For written/paper comments You may submit comments on any
submitted to the Dockets Management guidance at any time (see 21 CFR
ACTION: Notice of availability. 10.115(g)(5)).
Staff, FDA will post your comment, as
well as any attachments, except for Submit written requests for single
SUMMARY: The Food and Drug copies of the draft guidance to the
Administration (FDA or Agency) is information submitted, marked and
identified, as confidential, if submitted Division of Drug Information, Center for
announcing the availability of a draft Drug Evaluation and Research, Food
guidance for industry entitled ‘‘Waivers as detailed in ‘‘Instructions.’’
Instructions: All submissions received and Drug Administration, 10001 New
of the Single, Shared System REMS Hampshire Ave., Hillandale Building,
Requirement.’’ This guidance describes must include the Docket No. FDA–
2018–D–1043 for ‘‘Waivers of the 4th Floor, Silver Spring, MD 20993–
how FDA intends to consider granting a 0002, or to the Office of
waiver of the requirement in the Federal Single, Shared System Risk Evaluation
and Mitigation Strategy Requirement; Communication, Outreach and
Food, Drug, and Cosmetic Act (FD&C Development, Center for Biologics
Act) that the applicant for an Draft Guidance for Industry;
Availability.’’ Received comments will Evaluation and Research, Food and
abbreviated new drug application Drug Administration, 10903 New
(ANDA) and its reference listed drug be placed in the docket and, except for
those submitted as ‘‘Confidential Hampshire Ave., Bldg. 71, Rm. 3128,
(RLD) use a single, shared system (SSS) Silver Spring, MD 20993–0002. Send
for a required risk evaluation and Submissions,’’ publicly viewable at
https://www.regulations.gov or at the one self-addressed adhesive label to
mitigation strategy (REMS) with assist that office in processing your
elements to assure safe use (ETASU). Dockets Management Staff between 9
a.m. and 4 p.m., Monday through requests. See the SUPPLEMENTARY
DATES: Submit either electronic or Friday. INFORMATION section for electronic
daltland on DSKBBV9HB2PROD with NOTICES
written comments on the draft guidance • Confidential Submissions—To access to the draft guidance document.
by August 30, 2018 to ensure that the submit a comment with confidential FOR FURTHER INFORMATION CONTACT:
Agency considers your comment on this information that you do not wish to be Elaine Lippmann, Center for Drug
draft guidance before it begins work on made publicly available, submit your Evaluation and Research, Food and
the final version of the guidance. comments only as a written/paper Drug Administration, 10903 New
ADDRESSES: You may submit comments submission. You should submit two Hampshire Ave., Bldg. 51, Rm. 6238,
on any guidance at any time as follows: copies total. One copy will include the Silver Spring, MD 20993, 301–796–
VerDate Sep<11>2014 17:06 May 31, 2018 Jkt 244001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\01JNN1.SGM 01JNN1](https://thefederalregister.org/doc/83_FR_25571/page/1.svg)
![25466 Federal Register / Vol. 83, No. 106 / Friday, June 1, 2018 / Notices
3600, Elaine.Lippmann@fda.hhs.gov; or II. Paperwork Reduction Act of 1995 including each proposed extension of an
Stephen Ripley, Center for Biologics This draft guidance refers to existing collection of information, and
Evaluation and Research, Food and collections of information that are to allow 60 days for public comment in
Drug Administration, 10903 New subject to review by the Office of response to the notice. This notice
Hampshire Ave., Bldg. 71, Rm. 7301, Management and Budget (OMB) under solicits comments on the information
Silver Spring, MD 20993–0002, 240– the Paperwork Reduction Act of 1995 collection requirements associated with
402–7911. (PRA) (44 U.S.C. 3501–3520). The current good manufacturing practice,
SUPPLEMENTARY INFORMATION: preparation and submission of waiver hazard analysis, and risk-based
requests (as described in 21 CFR 314.90 preventive controls for human food.
I. Background
for new drug application applicants and DATES: Submit either electronic or
FDA is announcing the availability of 314.99(b) for ANDA applicants) has written comments on the collection of
a draft guidance for industry entitled been approved under OMB control information by July 31, 2018.
‘‘Waivers of the Single, Shared System number 0910–0001. In accordance with ADDRESSES: You may submit comments
REMS Requirement.’’ This guidance the PRA, before publication of the final as follows. Please note that late,
describes how the Agency intends to guidance document, FDA intends to untimely filed comments will not be
consider granting a waiver of the solicit public comment and obtain OMB considered. Electronic comments must
requirement in section 505–1(i) of the approval for any information collections be submitted on or before July 31, 2018.
FD&C Act (21 U.S.C. 355–1(i)) that the recommended in this guidance that are The https://www.regulations.gov
applicant for an ANDA and its RLD use new or that would represent material electronic filing system will accept
a SSS for a required REMS with ETASU. modifications to previously approved comments until midnight Eastern Time
Section 505–l(i)(l)(B) of the FD&C Act collections of information found in FDA at the end of July 31, 2018. Comments
requires that a holder of an ANDA regulations. received by mail/hand delivery/courier
under section 505(j) use a ‘‘single, (for written/paper submissions) will be
shared system’’ with the RLD for any III. Electronic Access
considered timely if they are
ETASU, unless FDA waives this Persons with access to the internet postmarked or the delivery service
requirement. The statute permits a may obtain the draft guidance at either acceptance receipt is on or before that
waiver of the SSS requirement if FDA https://www.fda.gov/Drugs/ date.
finds that (1) ‘‘the burden of creating a GuidanceCompliance
[SSS] outweighs the benefit of a single, RegulatoryInformation/Guidances/ Electronic Submissions
system, taking into consideration the default.htm, https://www.fda.gov/ Submit electronic comments in the
impact on health care providers, BiologicsBloodVaccines/Guidance following way:
patients, the applicant for the [ANDA], ComplianceRegulatoryInformation/ • Federal eRulemaking Portal:
and the holder of the reference drug Guidances/default.htm, or https:// https://www.regulations.gov. Follow the
product,’’ or (2) an aspect of the ETASU www.regulations.gov. instructions for submitting comments.
for the applicable listed drug is claimed Dated: May 24, 2018. Comments submitted electronically,
by an unexpired patent or trade secret including attachments, to https://
Leslie Kux,
and the ANDA applicant certifies that it www.regulations.gov will be posted to
Associate Commissioner for Policy.
sought a license for use of the aspect, the docket unchanged. Because your
but was unable to obtain one. If a waiver [FR Doc. 2018–11784 Filed 5–31–18; 8:45 am]
comment will be made public, you are
of the SSS requirement is granted, the BILLING CODE 4164–01–P
solely responsible for ensuring that your
ANDA may use ‘‘a different, comparable comment does not include any
aspect of the [ETASU],’’ instead of confidential information that you or a
participating in a SSS with the RLD. DEPARTMENT OF HEALTH AND
third party may not wish to be posted,
This guidance is intended to explain HUMAN SERVICES
such as medical information, your or
the factors FDA will consider in Food and Drug Administration anyone else’s Social Security number, or
evaluating a request for waiver of the confidential business information, such
SSS requirement and provide [Docket No. FDA–2011–N–0920] as a manufacturing process. Please note
recommendations to ANDA applicants that if you include your name, contact
regarding the submission and content of Agency Information Collection
information, or other information that
waiver requests. The guidance also Activities; Proposed Collection;
identifies you in the body of your
addresses FDA’s interpretation of what Comment Request; Current Good
comments, that information will be
constitutes a different, comparable Manufacturing Practice, Hazard
posted on https://www.regulations.gov.
Analysis, and Risk-Based Preventive
aspect of the ETASU as described in • If you want to submit a comment
section 505–1(i)(1)(B). Controls for Human Food
with confidential information that you
This draft guidance is being issued AGENCY: Food and Drug Administration, do not wish to be made available to the
consistent with FDA’s good guidance HHS. public, submit the comment as a
practices regulation (21 CFR 10.115). ACTION: Notice. written/paper submission and in the
The draft guidance, when finalized, will manner detailed (see ‘‘Written/Paper
represent the current thinking of FDA SUMMARY: The Food and Drug Submissions’’ and ‘‘Instructions’’).
on ‘‘Waivers of the Single, Shared Administration (FDA or Agency) is
System REMS Requirement.’’ It does not announcing an opportunity for public Written/Paper Submissions
daltland on DSKBBV9HB2PROD with NOTICES
establish any rights for any person and comment on the proposed collection of Submit written/paper submissions as
is not binding on FDA or the public. certain information by the Agency. follows:
You can use an alternative approach if Under the Paperwork Reduction Act of • Mail/Hand delivery/Courier (for
it satisfies the requirements of the 1995 (PRA), Federal Agencies are written/paper submissions): Dockets
applicable statutes and regulations. This required to publish notice in the Management Staff (HFA–305), Food and
guidance is not subject to Executive Federal Register concerning each Drug Administration, 5630 Fishers
Order 12866. proposed collection of information, Lane, Rm. 1061, Rockville, MD 20852.
VerDate Sep<11>2014 17:06 May 31, 2018 Jkt 244001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\01JNN1.SGM 01JNN1](https://thefederalregister.org/doc/83_FR_25571/page/2.svg)
Document Created: 2018-06-01 01:29:59
Document Modified: 2018-06-01 01:29:59
| 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 guidance by August 30, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Elaine Lippmann, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6238, Silver Spring, MD 20993, 301-796- 3600, [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. | |
| FR Citation | 83 FR 25465 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR