2020-05712. Development of a Shared System Risk Evaluation and Mitigation Strategy; Draft Guidance for Industry; Availability; Reopening of Comment Period

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability; reopening of the comment period.

SUMMARY:

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice entitled “Development of a Shared System REMS; Draft Guidance for Industry; Availability” that appeared in the Federal Register of June 1, 2018. The Agency is taking this action to allow interested persons additional time to submit comments.

DATES:

FDA is reopening the comment period for the notice published on June 1, 2018 (83 FR 25468). Submit either electronic or written comments on the draft guidance by May 18, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 guidances 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 Shared System REMS.” 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.govinfo.gov/​content/​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 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 (CBER), 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 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, 301-796-3600; 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, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of June 1, 2018, FDA published a notice with a 60-day comment period to request comments on the draft guidance for industry entitled “Development of Shared System REMS.” This draft 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. Section 610 of the Further Consolidated Appropriations Act, 2020 (Pub. L. 116-94, 133 Stat. 3524 (December 20, 2019)), amended section 505-1(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351-1(i)), regarding the requirement that a drug that is the subject of an abbreviated new drug application (ANDA) and its reference listed drug use a single, shared system for the elements to assure safe use unless FDA waives that requirement. We intend to revise the draft guidance accordingly. The Agency continues to recognize that shared system REMS may be in the interest of public health.

FDA is reopening the comment period until May 18, 2020. FDA is interested in receiving additional input regarding any further steps the Agency could take to facilitate successful formation of shared system REMS. In particular, FDA is seeking comment on the challenges and successes with: (1) Negotiating governance agreements among parties involved in a shared system REMS and (2) developing effective shared system REMS programs. The Agency believes that an additional 60 days will allow adequate time for interested persons to submit comments without compromising the timely publication of the final version of the guidance.

II. 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: March 13, 2020.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.