Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategy Submissions; Draft Guidance for Industry; Availability, 52058-52060 [2017-24353]

Download as PDF 52058 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices effectiveness but for which there was sufficient information to establish performance standards to provide such assurance. Condoms without spermicidal lubricant containing nonoxynol 9 are classified in class II. They were originally classified before the enactment of provisions of the Safe Medical Devices Act of 1990 (Pub. L. 101–629), which broadened the definition of class II devices and now permit FDA to establish special controls beyond performance standards, including guidance documents, to help provide reasonable assurance of the safety and effectiveness of such devices. In December 2000, Congress enacted Public Law 106–554, which directed FDA to ‘‘reexamine existing condom labels’’ and ‘‘determine whether the labels are medically accurate regarding the overall effectiveness or lack of effectiveness in preventing sexually transmitted diseases. . . .’’ In response, FDA recommended labeling intended to provide important information for condom users, including the extent of protection provided by condoms against various types of sexually transmitted diseases. Respondents to this collection of information are manufacturers and repackagers of male condoms made of natural rubber latex without spermicidal lubricant. FDA expects approximately five new manufacturers or repackagers to enter the market yearly and to collectively have a third-party disclosure burden of 60 hours. The number of respondents cited in table 1 is based on FDA’s database of premarket submissions and the electronic registration and listing database. The average burden per disclosure was derived from a study performed for FDA by Eastern Research Group, Inc., an economic consulting firm, to estimate the impact of the 1999 over-the-counter (OTC) human drug labeling requirements final rule (64 FR 13254, March 17, 1999). Because the packaging requirements for condoms are similar to those of many OTC drugs, we believe the burden to design the labeling for OTC drugs is an appropriate proxy for the estimated burden to design condom labeling. The special controls guidance document also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR part 801 have been approved under OMB control number 0910–0485; the collections of information in 21 CFR part 807 subpart E have been approved under OMB control number 0910–0120; and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910–0073. The collection of information under 21 CFR 801.437 does not constitute a ‘‘collection of information’’ under the Paperwork Reduction Act of 1995. Rather, it is a ‘‘public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public’’ (5 CFR 1320.3(c)(2)). FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Activity Number of respondents Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 .................................................................. 5 1 5 12 60 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The estimated burden of this information collection has not changed since the last OMB approval. Dated: November 6, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–24415 Filed 11–8–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration sradovich on DSK3GMQ082PROD with NOTICES Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategy Submissions; Draft Guidance for Industry; Availability Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is SUMMARY: VerDate Sep<11>2014 17:32 Nov 08, 2017 Jkt 244001 Submit either electronic or written comments on the draft guidance by January 8, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. DATES: [Docket No. FDA–2017–D–6231] AGENCY: announcing the availability of a draft guidance for industry entitled ‘‘Use of a Drug Master File for Shared System REMS Submissions.’’ The draft guidance provides information to applicants who are part of a shared system Risk Evaluation and Mitigation Strategy (REMS) on using an electronic Type V Drug Master File (DMF). FDA recommends that applicants who are part of a shared system REMS use a Type V DMF for their REMS submissions to improve the efficiency of the submission and review process. You may submit comments on any guidance at any time as follows: ADDRESSES: Electronic Submissions Submit electronic comments in the following way: PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 • 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’’). E:\FR\FM\09NON1.SGM 09NON1 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices sradovich on DSK3GMQ082PROD with NOTICES 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– 2017–D–6231 for ‘‘Use of a Drug Master File for Shared System REMS Submissions; 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// VerDate Sep<11>2014 17:32 Nov 08, 2017 Jkt 244001 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: Gita Toyserkani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2422, Silver Spring, MD 20993–0002, 301–796–1783, Gita.Toyserkani@fda.hhs.gov; 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 ‘‘Use a of Drug Master File for Shared System REMS Submissions.’’ A REMS is a required risk management plan that uses tools beyond the FDA-approved prescribing information to ensure that the benefits of certain drugs outweigh their risks (see section 505–1 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355–1)). FDA can, under certain circumstances, require that the REMS for a drug include one or more elements to assure safe use (ETASU) (see section 505–1(f) of the FD&C Act). When ETASUs are required for an innovator drug, any abbreviated new drug application (ANDA) referencing that innovator drug must use an shared system REMS with the innovator (unless FDA waives the requirement for using a shared system) (see section 505–1(i) of PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 52059 the FD&C Act). There are also circumstances under which multiple applicants form an SSR to minimize the burden on the health care delivery system, such as for a class of similar products. Under a shared system REMS, multiple applicants should coordinate the submission of identical documents to their respective applications. To improve the efficiency of the submission and review process for shared system REMS, FDA recommends that applicants who are part of a shared system REMS use a Type V DMF for their REMS submissions. A DMF is a submission to the Agency that may be used to provide confidential detailed information to the Agency. Among other things, a DMF allows the DMF holder to authorize other applicants to reference information in the holder’s DMF. A DMF is submitted solely at the discretion of the DMF holder, and the technical contents of a DMF are customarily reviewed by FDA only in connection with the review of an application. The use of a DMF is not a requirement for shared system REMS. However, if shared system REMS applicants choose to use the DMF option for their shared system REMS submissions, this guidance (and the technical conformance guide that supplements it, available at https://www.fda.gov/drugs/ developmentapprovalprocess/forms submissionrequirements/electronic submissions/ucm535180.htm) is intended to provide an overview of the approach for doing so. Also, if shared system REMS applicants choose to use the DMF option, as of the date specified by FDA, they must submit the DMF in the Electronic Common Technical Document format, as previously stated in the guidance for industry ‘‘Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (Revision 4)’’ (available at https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm). 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 use of a DMF for submission of 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. E:\FR\FM\09NON1.SGM 09NON1 52060 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR 314.50 have been approved under OMB control number 0910–0001; the collections of information in 21 CFR 314.70 have been approved under OMB control number 0910–0001; the collections of information in 21 CFR 201.57 have been approved under OMB control number 0910–0572; the collections of information in 21 CFR 314.420 have been approved under OMB control number 0910–0001; and the collections of information in 21 CFR part 601 have been approved under OMB control number 0910–0338. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm or https://www.regulations.gov. Dated: November 2, 2017. Lauren Silvis, Chief of Staff. [FR Doc. 2017–24353 Filed 11–8–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–6358] Blood Products Advisory Committee Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee (the Committee). The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues related to blood and products derived from blood. The meeting will be open to the public. DATES: The meeting will be held on November 30, 2017, from 8 a.m. to 5:45 sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:32 Nov 08, 2017 Jkt 244001 p.m. and on December 1, 2017, from 8 a.m. to 3:30 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD, 20993– 0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm408555.htm. FOR FURTHER INFORMATION CONTACT: Bryan Emery or Joanne Lipkind, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993–0002, Bldg. 71, Rm. 6132, at 240–402–8054, bryan.emery@ fda.hhs.gov and 240–402–8106, joanne.lipkind@fda.hhs.gov respectively, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. For those unable to attend in person, the meeting will also be available via Webcast. The Webcast will be available at the following link for both days: https://collaboration.fda.gov/ bpac2017. SUPPLEMENTARY INFORMATION: Agenda: On November 30, 2017, the Committee members will meet in open session to discuss bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion. In the afternoon, the Committee will be seated as a device classification panel. In open session, the panel will discuss the appropriate device classification of human leukocyte antigen, human platelet antigen, and human neutrophil antigen devices. On December 1, 2017, the committee members will meet in open session to discuss strategies to reduce the risk of transfusiontransmitted Zika virus. In the afternoon, an information session on the Transfusion Transmissible Infections Monitoring System will be presented to PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 the Committee. Finally, the Committee will hear an update presentation on the April 6, 2017, FDA public workshop on emerging tick-borne diseases and blood safety. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before November 22, 2017. Oral presentations from the public will be scheduled between approximately 11:35 a.m. to 12:20 p.m. and 4:15 p.m. to 4:45 p.m. on November 30, 2017. Oral presentations from the public will also be scheduled between approximately 10:45 a.m. and 11:30 a.m. and 3 p.m. to 3:30 p.m. on December 1, 2017. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 14, 2017. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 15, 2017. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Bryan Emery or Joanne Lipkind at least 7 days in advance of the meeting. E:\FR\FM\09NON1.SGM 09NON1

Agencies

[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)]
[Notices]
[Pages 52058-52060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24353]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6231]


Use of a Drug Master File for Shared System Risk Evaluation and 
Mitigation Strategy Submissions; 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 ``Use of a 
Drug Master File for Shared System REMS Submissions.'' The draft 
guidance provides information to applicants who are part of a shared 
system Risk Evaluation and Mitigation Strategy (REMS) on using an 
electronic Type V Drug Master File (DMF). FDA recommends that 
applicants who are part of a shared system REMS use a Type V DMF for 
their REMS submissions to improve the efficiency of the submission and 
review process.

DATES: Submit either electronic or written comments on the draft 
guidance by January 8, 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'').

[[Page 52059]]

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-2017-D-6231 for ``Use of a Drug Master File for Shared System REMS 
Submissions; 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.gpo.gov/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: Gita Toyserkani, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 2422, Silver Spring, MD 20993-0002, 301-
796-1783, Gita.Toyserkani@fda.hhs.gov; 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 ``Use a of Drug Master File for Shared System REMS 
Submissions.''
    A REMS is a required risk management plan that uses tools beyond 
the FDA-approved prescribing information to ensure that the benefits of 
certain drugs outweigh their risks (see section 505-1 of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355-1)). FDA 
can, under certain circumstances, require that the REMS for a drug 
include one or more elements to assure safe use (ETASU) (see section 
505-1(f) of the FD&C Act). When ETASUs are required for an innovator 
drug, any abbreviated new drug application (ANDA) referencing that 
innovator drug must use an shared system REMS with the innovator 
(unless FDA waives the requirement for using a shared system) (see 
section 505-1(i) of the FD&C Act). There are also circumstances under 
which multiple applicants form an SSR to minimize the burden on the 
health care delivery system, such as for a class of similar products.
    Under a shared system REMS, multiple applicants should coordinate 
the submission of identical documents to their respective applications. 
To improve the efficiency of the submission and review process for 
shared system REMS, FDA recommends that applicants who are part of a 
shared system REMS use a Type V DMF for their REMS submissions. A DMF 
is a submission to the Agency that may be used to provide confidential 
detailed information to the Agency. Among other things, a DMF allows 
the DMF holder to authorize other applicants to reference information 
in the holder's DMF. A DMF is submitted solely at the discretion of the 
DMF holder, and the technical contents of a DMF are customarily 
reviewed by FDA only in connection with the review of an application.
    The use of a DMF is not a requirement for shared system REMS. 
However, if shared system REMS applicants choose to use the DMF option 
for their shared system REMS submissions, this guidance (and the 
technical conformance guide that supplements it, available at https://www.fda.gov/drugs/developmentapprovalprocess/formssubmissionrequirements/electronicsubmissions/ucm535180.htm) is 
intended to provide an overview of the approach for doing so. Also, if 
shared system REMS applicants choose to use the DMF option, as of the 
date specified by FDA, they must submit the DMF in the Electronic 
Common Technical Document format, as previously stated in the guidance 
for industry ``Providing Regulatory Submissions in Electronic Format--
Certain Human Pharmaceutical Product Applications and Related 
Submissions Using the eCTD Specifications (Revision 4)'' (available at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm).
    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 use of a DMF 
for submission of 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.

[[Page 52060]]

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 314.50 have been approved under 
OMB control number 0910-0001; the collections of information in 21 CFR 
314.70 have been approved under OMB control number 0910-0001; the 
collections of information in 21 CFR 201.57 have been approved under 
OMB control number 0910-0572; the collections of information in 21 CFR 
314.420 have been approved under OMB control number 0910-0001; and the 
collections of information in 21 CFR part 601 have been approved under 
OMB control number 0910-0338.

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 or 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: November 2, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-24353 Filed 11-8-17; 8:45 am]
 BILLING CODE 4164-01-P
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