Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format; Draft Guidance for Industry; Availability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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.” This draft guidance is intended to assist holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) with their submission of required marketing status notifications.

DATES:

Submit either electronic or written comments on the draft guidance by April 1, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Submit either electronic or written comments concerning the collection of information proposed in the draft guidance by April 1, 2019.

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-4615 for “Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.” 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. 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:

Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 240-402-7930, elizabeth.giaquinto@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.” This draft guidance is intended to assist holders of NDAs and ANDAs approved under the FD&C Act with their submission of required marketing status notifications. The FDA Reauthorization Act of 2017 (Pub. L. 115-52) (FDARA) added section 506I to the FD&C Act (21 U.S.C. 356i), which imposes additional reporting requirements on NDA and ANDA holders regarding the marketing status of approved drug products. This draft guidance identifies the required content for these marketing status notifications and the format by which these notifications should be submitted to the Agency.

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 “Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.” 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

Under the Paperwork Reduction Act (44 U.S.C. 3501-3520) (the PRA), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing the proposed collection of information set forth in this notice of availability that would result from the submission of these FDARA notifications.

With respect to the following collection of information, FDA invites comment on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Title: Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format; Draft Guidance for Industry

Description: The draft guidance describes the FDARA requirement that NDA and ANDA holders must notify FDA of the marketing status of drug products approved under an NDA and ANDA. Applicants must provide the following information:

Notification of Withdrawal from Sale: NDA and ANDA holders must provide a written notification to FDA 180 days prior to withdrawing an approved drug from sale. Pursuant to section 506I(a) of the FD&C Act, the notification of a withdrawal from sale must include the following information:

1. The National Drug Code(s) under which the drug is listed (21 CFR part 207).

2. The established name of the drug.

3. The proprietary name of the drug, if applicable.

4. The NDA or ANDA number.

5. The strength of the drug.

6. The date on which the drug is expected to no longer be available for sale.

7. The reason for the withdrawal.

The applicant should submit the notification of a withdrawal from sale in a letter to the applicable NDA or ANDA file through the electronic submissions gateway, as described in the draft guidance. The notification should prominently identify the submission as an “ADMINISTRATIVE CHANGE/NOT AVAILABLE FOR SALE.”

Notification of Drug Not Available For Sale: NDA and ANDA holders must provide a written notification to FDA within 180 days of the date of approval of a drug if that drug will not be available for sale within 180 days of the date of approval. Pursuant to section 506I(b) of the FD&C Act, the notification that a drug is not available for sale within 180 days of the date of approval of the drug must include the following information:

1. The established name of the drug.

2. The proprietary name of the drug, if applicable.

3. The NDA or ANDA number.

4. The strength of the drug.

5. The date on which the drug will be available for sale, if known.

6. The reason for not marketing the drug after approval.

The applicant should submit the notification that a drug will not be available for sale in a letter to the applicable NDA or ANDA file through the electronic gateway. The notification should prominently identify the submission as an “ADMINISTRATIVE CHANGE/NOT AVAILABLE FOR SALE.” Once marketing begins, FDA recommends that the NDA or ANDA holder notify FDA of the commenced marketing in a letter to the applicable NDA or ANDA file through the electronic gateway to ensure that appropriate changes can be made in the Agency's publication, Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book). The notification should prominently identify the submission as an “ADMINISTRATIVE CHANGE/NOTIFICATION OF COMMERCIAL MARKETING.”

One-Time Report on Marketing Status: NDA and ANDA holders were required to provide a written notification to FDA by February 14, 2018, stating whether the NDA and ANDA holder's drug(s) in the active section of the Orange Book are available for sale or if one or more of the NDA or ANDA holder's drugs in the active section have been withdrawn from sale or have never been available for sale. This report was required to indicate whether:

1. All of the NDA or ANDA holder's drugs in the active section of the Orange Book were available for sale or

2. One or more of the NDA or ANDA holder's drugs in the active section of the Orange Book had been withdrawn from sale or had never been available for sale.

We estimate that a total of approximately 523 applicants (“number of respondents” in table 1) will submit annually approximately 523 Notifications of Withdrawal from Sale as described in the draft guidance (“total annual responses” in table 1). We estimate that preparing and submitting each notification will take approximately 30 minutes (“hours per response” in table 1). We base our estimates for the number of applicants and the number of notifications on information from our database of NDA and ANDA submissions. Our estimate of the time applicants would need to prepare and submit each notification is based on our familiarity with receiving these types of notifications.

We estimate that a total of approximately 30 applicants (“number of respondents” in table 1) will submit annually approximately 30 Notifications of Drug Not Available for Sale as described in the draft guidance (“total annual responses” in table 1). We estimate that preparing and submitting each notification will take approximately 30 minutes (“hours per response” in table 1). We base our estimates for the number of applicants and the number of notifications on information from our database of NDA and ANDA submissions. Our estimate of the time applicants would need to prepare and submit each notification is based on our familiarity with receiving these types of notifications. Once marketing begins, we estimate that these applicants will notify FDA of commenced marketing by submitting Notifications of Commercial Marketing as described in the draft guidance. We estimate that preparing and submitting each notification that commercial marketing has commenced will take approximately 15 minutes (“hours per response” in table 1).

A total of approximately 925 applicants (“number of respondents” in table 2) submitted approximately 10,319 One-Time Reports on Marketing Status as described in the draft guidance (“total annual responses” in table 2). We estimate that preparing and submitting each notification as described in the draft guidance took approximately 30 minutes (“hours per response” in table 2). We base our estimates of the number of applicants and the number of notifications on the actual number of one-time reports on marketing status submitted prior to February 14, 2018. Our estimate of the time applicants needed to prepare and submit each notification is based on our familiarity with receiving these types of notifications.

Under the PRA, FDA has already estimated and OMB has approved under control number 0910-0001 the collection of information contained in the submission of NDA and ANDA marketing status reports (e.g., notification of withdrawal from sale; notification of drug not available for sale) and related amendments, supplements, and other notifications required under subpart B and subpart C of part 314 in Title 21 of the Code of Federal Regulations (see, e.g., 21 CFR 314.81(b)(2)(ii)(a) and (b)(3)(iv)).

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.regulations.gov.