82 FR 52058 - Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategy Submissions; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 216 (November 9, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 216 (November 9, 2017)
| Page Range | 52058-52060 | |
| FR Document | 2017-24353 |
[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)] [Notices] [Pages 52058-52060] From the Federal Register Online [www.thefederalregister.org] [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No. FDA-2017-D-6231] Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategy Submissions; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Use of a Drug Master File for Shared System REMS Submissions.'' The draft guidance provides information to applicants who are part of a shared system Risk Evaluation and Mitigation Strategy (REMS) on using an electronic Type V Drug Master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 DATES: Submit either electronic or written comments on the draft guidance by January 8, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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.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: 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, [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 ``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
![52058 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices
effectiveness but for which there was protection provided by condoms against the estimated burden to design condom
sufficient information to establish various types of sexually transmitted labeling.
performance standards to provide such diseases. The special controls guidance
assurance. Respondents to this collection of
document also refers to previously
Condoms without spermicidal information are manufacturers and
lubricant containing nonoxynol 9 are repackagers of male condoms made of approved collections of information
classified in class II. They were natural rubber latex without spermicidal found in FDA regulations. The
originally classified before the lubricant. FDA expects approximately collections of information in 21 CFR
enactment of provisions of the Safe five new manufacturers or repackagers part 801 have been approved under
Medical Devices Act of 1990 (Pub. L. to enter the market yearly and to OMB control number 0910–0485; the
101–629), which broadened the collectively have a third-party collections of information in 21 CFR
definition of class II devices and now disclosure burden of 60 hours. The part 807 subpart E have been approved
permit FDA to establish special controls number of respondents cited in table 1 under OMB control number 0910–0120;
beyond performance standards, is based on FDA’s database of premarket and the collections of information in 21
including guidance documents, to help submissions and the electronic CFR part 820 have been approved under
provide reasonable assurance of the registration and listing database. The OMB control number 0910–0073.
safety and effectiveness of such devices. average burden per disclosure was The collection of information under
In December 2000, Congress enacted derived from a study performed for FDA 21 CFR 801.437 does not constitute a
Public Law 106–554, which directed by Eastern Research Group, Inc., an ‘‘collection of information’’ under the
FDA to ‘‘reexamine existing condom economic consulting firm, to estimate Paperwork Reduction Act of 1995.
labels’’ and ‘‘determine whether the the impact of the 1999 over-the-counter
Rather, it is a ‘‘public disclosure of
labels are medically accurate regarding (OTC) human drug labeling
the overall effectiveness or lack of information originally supplied by the
requirements final rule (64 FR 13254,
effectiveness in preventing sexually Federal Government to the recipient for
March 17, 1999). Because the packaging
transmitted diseases. . . .’’ In response, requirements for condoms are similar to the purpose of disclosure to the public’’
FDA recommended labeling intended to those of many OTC drugs, we believe (5 CFR 1320.3(c)(2)).
provide important information for the burden to design the labeling for FDA estimates the burden of this
condom users, including the extent of OTC drugs is an appropriate proxy for collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
Activity burden per Total hours
respondents per disclosures disclosure
respondent
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 announcing the availability of a draft • Federal eRulemaking Portal:
information collection has not changed guidance for industry entitled ‘‘Use of a https://www.regulations.gov. Follow the
since the last OMB approval. Drug Master File for Shared System instructions for submitting comments.
Dated: November 6, 2017. REMS Submissions.’’ The draft Comments submitted electronically,
Anna K. Abram, guidance provides information to including attachments, to https://
applicants who are part of a shared www.regulations.gov will be posted to
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis. system Risk Evaluation and Mitigation the docket unchanged. Because your
Strategy (REMS) on using an electronic comment will be made public, you are
[FR Doc. 2017–24415 Filed 11–8–17; 8:45 am]
Type V Drug Master File (DMF). FDA solely responsible for ensuring that your
BILLING CODE 4164–01–P
recommends that applicants who are comment does not include any
part of a shared system REMS use a confidential information that you or a
Type V DMF for their REMS third party may not wish to be posted,
DEPARTMENT OF HEALTH AND
submissions to improve the efficiency of such as medical information, your or
HUMAN SERVICES
the submission and review process. anyone else’s Social Security number, or
Food and Drug Administration confidential business information, such
DATES: Submit either electronic or as a manufacturing process. Please note
[Docket No. FDA–2017–D–6231] written comments on the draft guidance that if you include your name, contact
by January 8, 2018 to ensure that the information, or other information that
Use of a Drug Master File for Shared Agency considers your comment on this identifies you in the body of your
System Risk Evaluation and Mitigation draft guidance before it begins work on comments, that information will be
Strategy Submissions; Draft Guidance
sradovich on DSK3GMQ082PROD with NOTICES
the final version of the guidance. posted on https://www.regulations.gov.
for Industry; Availability • If you want to submit a comment
ADDRESSES: You may submit comments with confidential information that you
AGENCY: Food and Drug Administration,
on any guidance at any time as follows: do not wish to be made available to the
HHS.
ACTION: Notice of availability. Electronic Submissions public, submit the comment as a
written/paper submission and in the
SUMMARY: The Food and Drug Submit electronic comments in the manner detailed (see ‘‘Written/Paper
Administration (FDA or Agency) is following way: Submissions’’ and ‘‘Instructions’’).
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![52060 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices
II. Paperwork Reduction Act of 1995 p.m. and on December 1, 2017, from 8 the Committee. Finally, the Committee
This draft guidance refers to a.m. to 3:30 p.m. will hear an update presentation on the
previously approved collections of ADDRESSES: FDA White Oak Campus, April 6, 2017, FDA public workshop on
information found in FDA regulations. 10903 New Hampshire Ave., Building emerging tick-borne diseases and blood
These collections of information are 31 Conference Center, the Great Room safety.
subject to review by the Office of (Rm. 1503), Silver Spring, MD, 20993– FDA intends to make background
Management and Budget (OMB) under 0002. Answers to commonly asked material available to the public no later
the Paperwork Reduction Act of 1995 questions including information than 2 business days before the meeting.
(44 U.S.C. 3501–3520). The collections regarding special accommodations due If FDA is unable to post the background
of information in 21 CFR 314.50 have to a disability, visitor parking, and material on its Web site prior to the
been approved under OMB control transportation may be accessed at: meeting, the background material will
number 0910–0001; the collections of https://www.fda.gov/Advisory be made publicly available at the
information in 21 CFR 314.70 have been Committees/AboutAdvisoryCommittees/ location of the advisory committee
approved under OMB control number ucm408555.htm. meeting, and the background material
0910–0001; the collections of FOR FURTHER INFORMATION CONTACT: will be posted on FDA’s Web site after
information in 21 CFR 201.57 have been Bryan Emery or Joanne Lipkind, Center the meeting. Background material is
approved under OMB control number for Biologics Evaluation and Research, available at https://www.fda.gov/
0910–0572; the collections of Food and Drug Administration, 10903 AdvisoryCommittees/Calendar/
information in 21 CFR 314.420 have New Hampshire Avenue, Silver Spring, default.htm. Scroll down to the
been approved under OMB control MD 20993–0002, Bldg. 71, Rm. 6132, at appropriate advisory committee meeting
number 0910–0001; and the collections 240–402–8054, bryan.emery@ link.
of information in 21 CFR part 601 have fda.hhs.gov and 240–402–8106, Procedure: Interested persons may
been approved under OMB control joanne.lipkind@fda.hhs.gov present data, information, or views,
number 0910–0338. respectively, or FDA Advisory orally or in writing, on issues pending
Committee Information Line, 1–800– before the committee. Written
III. Electronic Access 741–8138 (301–443–0572 in the submissions may be made to the contact
Persons with access to the internet Washington, DC area). A notice in the person on or before November 22, 2017.
may obtain the draft guidance at either Federal Register about last minute Oral presentations from the public will
https://www.fda.gov/Drugs/Guidance modifications that impact a previously be scheduled between approximately
ComplianceRegulatoryInformation/ announced advisory committee meeting 11:35 a.m. to 12:20 p.m. and 4:15 p.m.
Guidances/default.htm or https:// cannot always be published quickly to 4:45 p.m. on November 30, 2017. Oral
www.fda.gov/BiologicsBloodVaccines/ enough to provide timely notice. presentations from the public will also
GuidanceComplianceRegulatory Therefore, you should always check the be scheduled between approximately
Information/Guidances/default.htm or Agency’s Web site at https:// 10:45 a.m. and 11:30 a.m. and 3 p.m. to
https://www.regulations.gov. www.fda.gov/AdvisoryCommittees/ 3:30 p.m. on December 1, 2017. Those
Dated: November 2, 2017. default.htm and scroll down to the individuals interested in making formal
appropriate advisory committee meeting oral presentations should notify the
Lauren Silvis,
link, or call the advisory committee contact person and submit a brief
Chief of Staff.
information line to learn about possible statement of the general nature of the
[FR Doc. 2017–24353 Filed 11–8–17; 8:45 am] evidence or arguments they wish to
modifications before coming to the
BILLING CODE 4164–01–P meeting. For those unable to attend in present, the names and addresses of
person, the meeting will also be proposed participants, and an
available via Webcast. The Webcast will indication of the approximate time
DEPARTMENT OF HEALTH AND requested to make their presentation on
be available at the following link for
HUMAN SERVICES or before November 14, 2017. Time
both days: https://collaboration.fda.gov/
Food and Drug Administration bpac2017. allotted for each presentation may be
SUPPLEMENTARY INFORMATION: limited. If the number of registrants
[Docket No. FDA–2017–N–6358] Agenda: On November 30, 2017, the requesting to speak is greater than can
Committee members will meet in open be reasonably accommodated during the
Blood Products Advisory Committee scheduled open public hearing session,
session to discuss bacterial risk control
Advisory Committee; Notice of Meeting FDA may conduct a lottery to determine
strategies for blood collection
AGENCY: Food and Drug Administration, establishments and transfusion services the speakers for the scheduled open
HHS. to enhance the safety and availability of public hearing session. The contact
ACTION: Notice. platelets for transfusion. In the person will notify interested persons
afternoon, the Committee will be seated regarding their request to speak by
SUMMARY: The Food and Drug as a device classification panel. In open November 15, 2017.
Administration (FDA) announces a session, the panel will discuss the Persons attending FDA’s advisory
forthcoming public advisory committee appropriate device classification of committee meetings are advised that the
meeting of the Blood Products Advisory human leukocyte antigen, human Agency is not responsible for providing
Committee (the Committee). The general platelet antigen, and human neutrophil access to electrical outlets.
function of the committee is to provide antigen devices. On December 1, 2017, FDA welcomes the attendance of the
sradovich on DSK3GMQ082PROD with NOTICES
advice and recommendations to the the committee members will meet in public at its advisory committee
Agency on FDA’s regulatory issues open session to discuss strategies to meetings and will make every effort to
related to blood and products derived reduce the risk of transfusion- accommodate persons with disabilities.
from blood. The meeting will be open to transmitted Zika virus. In the afternoon, If you require accommodations due to a
the public. an information session on the disability, please contact Bryan Emery
DATES: The meeting will be held on Transfusion Transmissible Infections or Joanne Lipkind at least 7 days in
November 30, 2017, from 8 a.m. to 5:45 Monitoring System will be presented to advance of the meeting.
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Document Created: 2018-10-25 10:29:04
Document Modified: 2018-10-25 10:29:04
| 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 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. | |
| 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, [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 | 82 FR 52058 |
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