83 FR 25468 - Development of a Shared System Risk Evaluation and Mitigation Strategy; Draft Guidance for Industry; Availability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 | 25468-25469 | |
| FR Document | 2018-11783 |
[Federal Register Volume 83, Number 106 (Friday, June 1, 2018)] [Notices] [Pages 25468-25469] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-11783] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-1041] Development of a Shared System Risk Evaluation and Mitigation Strategy; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Development of a Shared System REMS.'' This draft guidance provides recommendations on the development of a shared system risk evaluation and mitigation strategy (REMS) for multiple prescription drug (including biological) products. This guidance describes some of the possible benefits of a shared system REMS, and provides general principles and recommendations to assist industry with the development of these programs. DATES: Submit either electronic or written comments on the draft guidance by July 31, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-1041 for ``Development of a Shared System REMS; Draft Guidance for Industry; Availability.'' Received comments will be placed in the docket and, except for those submitted as [[Page 25469]] ``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. 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: Lubna Merchant, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4418, Silver Spring, MD 20993-0002, 301- 796-5162, email: [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 ``Development of a Shared System REMS.'' This guidance describes some of the possible benefits of shared system REMS, and provides general principles and recommendations to assist industry with the development of these programs. Section 505-l(i)(l)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1((i)(1)(B)) requires that a holder of an abbreviated new drug application (ANDA) approved under section 505(j) use a ``single, shared system'' with the reference listed drug (RLD) for any REMS with elements to assure safe use (ETASU) unless FDA waives this requirement. The requirement under section 505-1(i)(1)(B) regarding a ``single, shared system'' only applies to ANDAs. However, FDA recognizes that it may be in the interest of public health to have a shared system REMS in other cases because it may increase efficiencies for applicants and stakeholders. A shared system REMS can encompass multiple prescription drug products and can be developed and implemented jointly by two or more applicants. It can be a program shared by a drug that is the subject of an ANDA and the listed drug, as required in section 505- 1(i)(1)(B) (described above). It can also involve multiple new drug applications, ANDAs, or biologics license applications, approved under section 505(b)(1), (b)(2), or (j) of the FD&C Act (21 U.S.C. 355(b)(1), (b)(2) or (j)) or section 351(a) or (k) of the PHS Act (42 U.S.C. 262(a) or (k)), respectively, that form a shared system voluntarily. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance entitled ``Waivers of the Single, Shared System REMS Requirement.'' Among other things, that guidance describes how FDA will consider granting a waiver of the requirement in section 505-1(i) of the FD&C Act that the applicant for an ANDA and its RLD use a single, shared system for REMS with ETASU. 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 ``Development of a Shared System REMS.'' 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 a drug master file (as described in 21 CFR 314.420) by applicants for their shared system REMS submissions 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 http://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. 2018-11783 Filed 5-31-18; 8:45 am] BILLING CODE 4164-01-P
![25468 Federal Register / Vol. 83, No. 106 / Friday, June 1, 2018 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
117.126(c) and 117.170(d); food safety plan and re- 46,685 1 46,685 110 ........................ 5,135,350
analysis.
117.136; assurance records ....................................... 16,285 1 16,285 0.25 (15 minutes) .. 4,071
117.145(c); monitoring records .................................. 8,143 730 5,944,390 0.05 (3 minutes) .... 297,220
117.150(d); corrective actions and corrections 16,285 2 32,570 1 ............................ 32,570
records.
117.155(b); verification records .................................. 8,143 244 1,986,892 0.05 (3 minutes) .... 99,345
117.160; validation records ........................................ 3,677 6 22,062 0.25 (15 minutes) .. 5,515
117.475(c)(7)-(9); supplier records ............................ 16,285 10 162,850 4 ............................ 651,400
117.180(d); training records for preventive controls 46,685 1 46,685 0.25 (15 minutes) .. 11,671
qualified individual.
Total .................................................................... ........................ .......................... ........................ ............................... 6,237,142
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of Total annual
21 CFR section disclosures burden per Total hours
respondents disclosures
per respondent disclosure
117.201(e); disclosure of food manufacturing facility 37,134 1 37,134 0.25 (15 minutes) .. 9,284
address.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
These figures are based on our announcing the availability of a draft such as medical information, your or
regulatory impact analysis in support of guidance for industry entitled anyone else’s Social Security number, or
the final rule on preventive controls for ‘‘Development of a Shared System confidential business information, such
human food, which published in the REMS.’’ This draft guidance provides as a manufacturing process. Please note
Federal Register of September 17, 2015 recommendations on the development that if you include your name, contact
(80 FR 55908). Using Agency data, we of a shared system risk evaluation and information, or other information that
estimated the number of food facilities mitigation strategy (REMS) for multiple identifies you in the body of your
that we believe are subject to the prescription drug (including biological) comments, that information will be
regulations. We base our estimate of the products. This guidance describes some posted on https://www.regulations.gov.
time necessary for the individual of the possible benefits of a shared • If you want to submit a comment
reporting, recordkeeping, and third- system REMS, and provides general with confidential information that you
party disclosure activities on our principles and recommendations to do not wish to be made available to the
experience with similar information assist industry with the development of public, submit the comment as a
collections. these programs. written/paper submission and in the
DATES: Submit either electronic or
manner detailed (see ‘‘Written/Paper
Dated: May 25, 2018.
written comments on the draft guidance Submissions’’ and ‘‘Instructions’’).
Leslie Kux,
Associate Commissioner for Policy. by July 31, 2018 to ensure that the Written/Paper Submissions
[FR Doc. 2018–11801 Filed 5–31–18; 8:45 am]
Agency considers your comment on this Submit written/paper submissions as
draft guidance before it begins work on follows:
BILLING CODE 4164–01–P
the final version of the guidance. • Mail/Hand delivery/Courier (for
ADDRESSES: You may submit comments written/paper submissions): Dockets
DEPARTMENT OF HEALTH AND on any guidance at any time as follows: Management Staff (HFA–305), Food and
HUMAN SERVICES Electronic Submissions Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Food and Drug Administration Submit electronic comments in the • For written/paper comments
following way: submitted to the Dockets Management
[Docket No. FDA–2018–D–1041] • Federal eRulemaking Portal: Staff, FDA will post your comment, as
https://www.regulations.gov. Follow the well as any attachments, except for
Development of a Shared System Risk
instructions for submitting comments. information submitted, marked and
Evaluation and Mitigation Strategy;
Comments submitted electronically, identified, as confidential, if submitted
Draft Guidance for Industry;
including attachments, to https:// as detailed in ‘‘Instructions.’’
daltland on DSKBBV9HB2PROD with NOTICES
Availability
www.regulations.gov will be posted to Instructions: All submissions received
AGENCY: Food and Drug Administration, the docket unchanged. Because your must include the Docket No. FDA–
HHS. comment will be made public, you are 2018–D–1041 for ‘‘Development of a
ACTION: Notice of availability. solely responsible for ensuring that your Shared System REMS; Draft Guidance
comment does not include any for Industry; Availability.’’ Received
SUMMARY: The Food and Drug confidential information that you or a comments will be placed in the docket
Administration (FDA or Agency) is third party may not wish to be posted, and, except for those submitted as
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![Federal Register / Vol. 83, No. 106 / Friday, June 1, 2018 / Notices 25469
‘‘Confidential Submissions,’’ publicly Evaluation and Research, Food and This draft guidance is being issued
viewable at https://www.regulations.gov Drug Administration, 10903 New consistent with FDA’s good guidance
or at the Dockets Management Staff Hampshire Ave., Bldg. 22, Rm. 4418, practices regulation (21 CFR 10.115).
between 9 a.m. and 4 p.m., Monday Silver Spring, MD 20993–0002, 301– The draft guidance, when finalized, will
through Friday. 796–5162, email: Lubna.Merchant@ represent the current thinking of FDA
• Confidential Submissions—To fda.hhs.gov; or Stephen Ripley, Center on ‘‘Development of a Shared System
submit a comment with confidential for Biologics Evaluation and Research, REMS.’’ It does not establish any rights
information that you do not wish to be Food and Drug Administration, 10903 for any person and is not binding on
made publicly available, submit your New Hampshire Ave., Bldg. 71, Rm. FDA or the public. You can use an
comments only as a written/paper 7301, Silver Spring, MD 20993–0002, alternative approach if it satisfies the
submission. You should submit two 240–402–7911. requirements of the applicable statutes
copies total. One copy will include the SUPPLEMENTARY INFORMATION: and regulations. This guidance is not
information you claim to be confidential subject to Executive Order 12866.
with a heading or cover note that states I. Background
‘‘THIS DOCUMENT CONTAINS II. Paperwork Reduction Act of 1995
FDA is announcing the availability of
CONFIDENTIAL INFORMATION.’’ The a draft guidance for industry entitled This draft guidance refers to
Agency will review this copy, including ‘‘Development of a Shared System collections of information that are
the claimed confidential information, in REMS.’’ This guidance describes some subject to review by the Office of
its consideration of comments. The of the possible benefits of shared system Management and Budget (OMB) under
second copy, which will have the REMS, and provides general principles the Paperwork Reduction Act of 1995
claimed confidential information and recommendations to assist industry (PRA) (44 U.S.C. 3501–3520). The
redacted/blacked out, will be available with the development of these preparation and submission of a drug
for public viewing and posted on programs. master file (as described in 21 CFR
https://www.regulations.gov. Submit 314.420) by applicants for their shared
Section 505–l(i)(l)(B) of the Federal
both copies to the Dockets Management system REMS submissions has been
Food, Drug, and Cosmetic Act (FD&C
Staff. If you do not wish your name and approved under OMB control number
Act) (21 U.S.C. 355–1((i)(1)(B)) requires
contact information to be made publicly 0910–0001. In accordance with the PRA,
that a holder of an abbreviated new drug
available, you can provide this before publication of the final guidance
application (ANDA) approved under
information on the cover sheet and not document, FDA intends to solicit public
section 505(j) use a ‘‘single, shared
in the body of your comments and you comment and obtain OMB approval for
system’’ with the reference listed drug
must identify this information as
(RLD) for any REMS with elements to any information collections
‘‘confidential.’’ Any information marked
assure safe use (ETASU) unless FDA recommended in this guidance that are
as ‘‘confidential’’ will not be disclosed
waives this requirement. new or that would represent material
except in accordance with 21 CFR 10.20
The requirement under section 505– modifications to previously approved
and other applicable disclosure law. For
1(i)(1)(B) regarding a ‘‘single, shared collections of information found in FDA
more information about FDA’s posting
system’’ only applies to ANDAs. regulations.
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access However, FDA recognizes that it may be III. Electronic Access
the information at: https://www.gpo.gov/ in the interest of public health to have
fdsys/pkg/FR-2015-09-18/pdf/2015- a shared system REMS in other cases Persons with access to the internet
23389.pdf. because it may increase efficiencies for may obtain the draft guidance at either
Docket: For access to the docket to applicants and stakeholders. A shared http://www.fda.gov/Drugs/
read background documents or the system REMS can encompass multiple GuidanceCompliance
electronic and written/paper comments prescription drug products and can be RegulatoryInformation/Guidances/
received, go to https:// developed and implemented jointly by default.htm, https://www.fda.gov/
www.regulations.gov and insert the two or more applicants. It can be a BiologicsBloodVaccines/Guidance
docket number, found in brackets in the program shared by a drug that is the ComplianceRegulatoryInformation/
heading of this document, into the subject of an ANDA and the listed drug, Guidances/default.htm, or https://
‘‘Search’’ box and follow the prompts as required in section 505–1(i)(1)(B) www.regulations.gov.
and/or go to the Dockets Management (described above). It can also involve Dated: May 24, 2018.
Staff, 5630 Fishers Lane, Rm. 1061, multiple new drug applications, Leslie Kux,
Rockville, MD 20852. ANDAs, or biologics license
Associate Commissioner for Policy.
You may submit comments on any applications, approved under section
[FR Doc. 2018–11783 Filed 5–31–18; 8:45 am]
guidance at any time (see 21 CFR 505(b)(1), (b)(2), or (j) of the FD&C Act
(21 U.S.C. 355(b)(1), (b)(2) or (j)) or BILLING CODE 4164–01–P
10.115(g)(5)).
Submit written requests for single section 351(a) or (k) of the PHS Act (42
copies of the draft guidance to the U.S.C. 262(a) or (k)), respectively, that
Division of Drug Information, Center for DEPARTMENT OF HEALTH AND
form a shared system voluntarily.
Drug Evaluation and Research, Food HUMAN SERVICES
Elsewhere in this issue of the Federal
and Drug Administration, 10001 New Register, FDA is announcing the Meeting of the Pain Management Best
Hampshire Ave., Hillandale Building, availability of a draft guidance entitled Practices Inter-Agency Task Force;
4th Floor, Silver Spring, MD 20993– ‘‘Waivers of the Single, Shared System Amendment
daltland on DSKBBV9HB2PROD with NOTICES
0002. Send one self-addressed adhesive REMS Requirement.’’ Among other
label to assist that office in processing things, that guidance describes how AGENCY: Office of the Assistant
your requests. See the SUPPLEMENTARY FDA will consider granting a waiver of Secretary for Health, Office of the
INFORMATION section for electronic the requirement in section 505–1(i) of Secretary, Department of Health and
access to the draft guidance document. the FD&C Act that the applicant for an Human Services.
FOR FURTHER INFORMATION CONTACT: ANDA and its RLD use a single, shared
ACTION: Notice; amendment.
Lubna Merchant, Center for Drug system for REMS with ETASU.
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Document Created: 2018-06-01 01:29:35
Document Modified: 2018-06-01 01:29:35
| 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 July 31, 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 | Lubna Merchant, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4418, Silver Spring, MD 20993-0002, 301- 796-5162, email: [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 25468 |
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