Importation of Certain Food and Drug Administration-Approved Human Prescription Drugs, Including Biological Products, Under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability; Correction, 71961-71964 [2019-28141]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 84, No. 249 / Monday, December 30, 2019 / Notices 510(k) submission by 15 minutes per submission. • We corrected the burden table to include a line for the ‘‘510(k) Summary’’ under § 807.92. This section was inadvertently removed from the previous version of the information collection request (ICR). • We are making available Form FDA 3881 ‘‘Indications for Use’’ that respondents include as part of a medical device 510(k). The information provided via the form is already approved under this ICR. The form does not ask for new information and does not bear on the underlying program or on the hour or cost burden associated with the information collection, rather it provides a fillable, 508-compliant format for respondents to use for the ‘‘Indications for Use’’ portion of their 510(k) submission. • We updated the guidance ‘‘Refuse to Accept Policy for 510(k)s’’ to explicitly recommend providing an Acceptance Checklist in the 510(k) submission. The guidance previously provided the checklist as an example of a tool that FDA staff use when reviewing a 510(k) submission. While it was not explicitly recommended, respondents had used the example and had included it with their 510(k) submission. We believe the checklist can be a helpful tool for both reviewers and 510(k) submitters and have therefore updated the guidance to explicitly recommend inclusion of the checklist in the 510(k) submission. Because most submitters included the checklist on their own initiative and because it may simplify preparation of the 510(k), we do not believe adding the checklist to this ICR affects the overall burden for a 510(k) submission. Additionally, we have updated the checklist to include combination products, as appropriate. The estimated number of responses as updated with current data in this submission, reflects the inclusion of combination products. • We revised and reformatted Form FDA 3514, ‘‘CDRH Premarket Review Submission Cover Sheet,’’ to improve usability and to be inclusive of most medical device product submission types. Form FDA 3514, a summary cover sheet form, assists respondents in categorizing 510(k) information for submission to FDA. This form also assists respondents in categorizing information for other FDA medical device programs. The total burden for Form FDA 3514 and for the 510(k) program is estimated in this ICR. The burden for the other medical device programs listed on Form FDA 3514 are approved under the corresponding product submission ICRs as follows: VerDate Sep<11>2014 20:00 Dec 27, 2019 Jkt 250001 premarket approval applications (OMB control number 0910–0231), investigational device exemptions (OMB control number 0910–0078), humanitarian device exemptions (control number 0910–0332), CLIA waivers (OMB control number 0910– 0598), Q-Submissions (OMB control number 0910–0756), De Novo requests (OMB control number 0910–0844), Emergency Use Authorizations (OMB control number 0910–0595), 513(g) requests (OMB control number 0910– 0705); and Appeals (OMB control number 0910–0738). • Certain revisions to Form FDA 3514, as previously described, eliminate the need for Form FDA 3654, ‘‘Standards Data Report for 510(k)s.’’ Additionally, the ability for Form FDA 3514 to be expandable for the number of standards cited will increase awareness of actual standards in a submission and how they were used on a single form (compared to including several Form FDA 3654 documents). In the rare occasions where the sponsor elects to not use Form FDA 3514 for standards, this would not have any effect on the review outcome, with regard to standards, as the form serves as a means to identify what standards are cited, how they are used, and where in the submission they are located. • We have removed Form FDA 3541, ‘‘Status Request.’’ In practice, Form FDA 3541 is rarely used. We have adjusted the burden estimate to reflect this removal. Under § 807.90(a)(3), all inquiries regarding a premarket notification submission should be in writing and sent to one of the addresses listed in § 807.90(a). • We have added burden estimates for the eSTAR and eSTAR setup (onetime burden). Under section 745A(b) of FD&C Act, amended by section 207 of FDARA (Pub. L. 115–52), and consistent with the MDUFA IV Commitment Letter, FDA has developed the eSTAR (eSTAR, Form FDA 4062) for 510(k) submissions to facilitate the preparation of submissions in electronic format. We expect to receive approximately 100 510(k) submissions via eSTAR per year. We estimate that eSTAR submissions will take approximately 40 hours per submission. Additionally, we’ve estimated a one-time setup burden of 5 minutes for approximately 80 new eSTAR users annually. The adjustments and revisions previously mentioned have resulted in a 39,473-hour decrease in the total hour burden estimate since the last OMB approval. PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 71961 Dated: December 13, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–28098 Filed 12–27–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–D–5743] Importation of Certain Food and Drug Administration-Approved Human Prescription Drugs, Including Biological Products, Under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability; Correction AGENCY: Food and Drug Administration, HHS. Notice of availability; correction. ACTION: This document corrects the Notice of Availability from the Food and Drug Administration (FDA, Agency, or we) announcing the availability of a draft guidance for industry entitled ‘‘Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act,’’ which published in the Federal Register on Monday, December 23, 2019. This draft guidance describes procedures to obtain a National Drug Code (NDC) for an FDAapproved prescription drug that is imported into the United States in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), which would provide an additional avenue through which drugs could be sold at a lower cost in the U.S. market. This draft guidance is intended to address certain challenges in the private market faced by manufacturers seeking to sell their drugs at lower costs. The Notice was published with two omissions. This document corrects those omissions by republishing the Notice in its entirety to include the omitted language. DATES: Submit either electronic or written comments on the draft guidance by February 21, 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 guidance at any time as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: E:\FR\FM\30DEN1.SGM 30DEN1 71962 Federal Register / Vol. 84, No. 249 / Monday, December 30, 2019 / Notices • 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’’). khammond on DSKJM1Z7X2PROD 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– 2019–D–5743 for ‘‘Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act.’’ 1 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 1 In the Federal Register of December 23, 2019 (84 FR 70557), FDA issued a Notice of Availability for this guidance, the subject of this correction notice. VerDate Sep<11>2014 20:00 Dec 27, 2019 Jkt 250001 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-201509-18/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 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: Lyndsay Hennessey, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 20993–0002, 301–796–7605, 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 ‘‘Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act,’’ which, when finalized, will represent the Agency’s current thinking on the importation of multi-market approved (MMA) products. This draft guidance describes procedures to obtain an NDC for an FDA-approved prescription drug that is imported into the United States in compliance with section 801 of the FD&C Act (21 U.S.C. 381), which would provide an additional avenue through which drugs could be sold at a lower cost in the U.S. market. In recent years, FDA has become aware that some drug manufacturers may be interested in offering certain of their drugs at lower costs and that obtaining additional NDCs for these drugs may help them to address certain challenges in the private market. This guidance is not intended to address the applicability of the Medicaid drug rebate program for manufacturers, which may be addressed in further guidance from other components of HHS. This guidance is intended to outline a potential pathway by which manufacturers could obtain an additional NDC for an FDA-approved drug that was originally intended to be marketed in a foreign country. This guidance specifically addresses the importation of FDA-approved drugs that were also authorized for sale in a foreign country in which the drugs were originally intended to be marketed (‘‘MMA product’’). This guidance describes: (1) The process for submitting a supplement to an approved FDA application for an MMA product; (2) the recommended labeling for an MMA product; (3) the process for registration and listing and for obtaining an NDC for the MMA product; (4) the requirements of section 582 of the FD&C Act (21 U.S.C. 360eee–1) as added by the Drug Supply Chain Security Act (DSCSA) (Title II of Pub. L. 113–54); (5) recommendations related to procedures for importation of the MMA product; and (6) other FDA requirements applicable to MMA products. This guidance, when finalized, will help ensure manufacturers are aware of E:\FR\FM\30DEN1.SGM 30DEN1 Federal Register / Vol. 84, No. 249 / Monday, December 30, 2019 / Notices khammond on DSKJM1Z7X2PROD with NOTICES procedures to provide access to lowercost drugs in the United States.2 The guidance details procedures that will enable manufacturers to obtain an additional NDC for the MMA product, which could allow greater pricing flexibility for a drug or biological product. The additional NDC also will support pharmacovigilance, accurate billing and reimbursement, and facilitate clearance of the MMA products through customs. This draft guidance is not final nor is it in effect at this time. 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 the importation of MMA products. 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. II. Issues for Consideration As previously noted, FDA is interested in receiving comments on the draft guidance. Regarding the approach set forth in the draft guidance, in addition to any other issues addressed, FDA requests that commenters consider the following issues when submitting comments: 1. Are there additional considerations for certain types of drug products with special handling, such as sterile injectables, drugs with boxed warnings, drugs with REMS (Risk Evaluation and Mitigation Strategy), controlled substances, or drugs that do not meet the definition of ‘‘product’’ under the DSCSA (21 U.S.C. 360eee(13))? Are there additional considerations for combination products related to the content of the guidance (e.g., supplement, labeling, NDC) that would warrant additional guidance for use of this approach for those products? To the extent that interested parties believe that different or additional considerations from those described in the draft guidance should apply to such an approach for combination products, we are interested in input on that, as well. 2. The draft guidance uses ‘‘MMA product’’ to describe FDA-approved drugs that were originally intended to be marketed in a foreign country and also authorized for sale in that foreign country. Is this new term adequate and 2 In the Federal Register of December 23, 2019 (84 FR 70796), FDA issued a Notice of Proposed Rulemaking under 21 U.S.C. 384 to offer a pathway for importation of drugs from Canada without the authorization of the manufacturer. VerDate Sep<11>2014 20:00 Dec 27, 2019 Jkt 250001 understandable? Is there another term that would provide more clarity regarding the products discussed in the guidance? 3. The draft guidance describes how an NDC could be obtained for MMA products. What is the effect of a manufacturer using a new labeler code as opposed to a new product code to distinguish these products, such as for reimbursement? 4. The draft guidance recommends a labeling statement in the FDA-approved labeling for the MMA product, including the carton and container label, to assist pharmacists and others in accurately identifying, dispensing, and billing for these products. FDA seeks comment on the specific wording that could be included in the statement to differentiate MMA products from other drugs that are not the subject of the guidance, if finalized, and to help ensure MMA products are easily identifiable to pharmacists and not confusing to patients. FDA also seeks comment on other types of distinguishing characteristics on the carton and container label that would further enable pharmacists to identify an MMA product and distinguish it from other packages of the FDAapproved drug, without confusing patients and consistent with other applicable requirements relating to carton and container labeling. Additionally, would other possible mechanisms, such as a Dear Healthcare Provider letter, provide further clarity and reduce confusion for pharmacists and other healthcare providers as well as patients? 5. We request comment about how much, on average, the labeling and packaging changes described in the draft guidance would cost drug manufacturers and repackagers or relabelers. Are there other ways to distinguish the appearance of an MMA product? We also request comment about alternative labeling approaches that would display the required information with equal prominence but may result in lower costs. 6. The draft guidance describes procedures for manufacturers of drug products approved under new drug applications or biologics license applications to obtain an additional NDC for an MMA product. FDA is interested as to whether manufacturers of generic drugs approved under an abbreviated new drug application confront similar pricing issues such that it would be appropriate to provide guidance on a similar approach for generic drugs. To the extent that interested parties believe that different considerations should apply to such an PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 71963 approach for generic drugs from those described in the draft guidance, input is requested on that as well. 7. There are complex considerations that impact biosimilar development, market entry, and uptake. We are interested in the possible impacts of MMA products that are biological products on biosimilar development, market entry, and uptake. 8. Similarly, there are complex considerations impacting generic drug market entry. We are interested in the possible impacts of MMA products on generic drug development and market entry. 9. Are there voluntary steps a manufacturer may take in addition to the requirements in the DSCSA to ensure the security of the supply chain for products imported pursuant to the guidance? 10. Are there any potential risks associated with the importation of products as described in the draft guidance that could be addressed by a rulemaking? For example, to what extent, if any, are there additional procedures that might better protect against entities seeking to introduce counterfeit drugs in the United States? If so, please be specific about the potential risk and how it could be addressed through rulemaking. 11. The draft guidance describes a pathway that manufacturers could use to offer their products to Americans at a lower price. FDA is interested in the factors that could contribute to the decision to use this pathway and whether there are reasons to use this pathway other than the ability to sell products at a lower price. III. Paperwork Reduction Act of 1995 FDA has tentatively concluded that there are no new collections of information in this draft guidance. This draft guidance refers to previously approved collections of information found in the FD&C Act and 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. 3501–3521). In accordance with the Paperwork Reduction Act, if FDA’s tentative conclusion changes, prior to publication of any 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 those previously approved collections of information found in FDA regulations or guidances. E:\FR\FM\30DEN1.SGM 30DEN1 71964 Federal Register / Vol. 84, No. 249 / Monday, December 30, 2019 / Notices The collections of information in 21 CFR part 314 (new drug applications) have been approved under OMB control number 0910–0001; the collections of information in 21 CFR part 601 (biologics license applications) have been approved under OMB control number 0910–0338; the collections of information in 21 CFR part 207 (domestic and foreign facility registration, including assignment of an NDC) have been approved under OMB control number 0910–0045; the collections of information in 21 CFR part 1 (general enforcement regulations) have been approved under OMB control number 0910–0046; the collections of information in 21 CFR part 201 (labeling) have been approved under OMB control number 0910–0572; the collections of information pertaining to current good manufacturing practice requirements for finished pharmaceuticals and combination products under 21 CFR parts 4, 210, 211, 610, and 680 have been approved under OMB control numbers 0910–0139 and 0910–0834; and the collections of information pertaining to suspect product identification and notification under section 582 of the FD&C Act have been approved under OMB control number 0910–0806. IV. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/vaccines-blood-biologics/ guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https:// www.regulations.gov. Dated: December 23, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–28141 Filed 12–27–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health khammond on DSKJM1Z7X2PROD with NOTICES National Cancer Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications VerDate Sep<11>2014 20:00 Dec 27, 2019 Jkt 250001 and/or contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; Collaborative Partnerships in Cancer Research P20. Date: February 25, 2020. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W606, Rockville, MD 20850, (Telephone Conference Call). Contact Person: Timothy C. Meeker, M.D., Ph.D., Scientific Review Officer, Special Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, 7W606, Rockville, MD 20850, 240–276–6464, meekert@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; TEP–10: SBIR Contract Review Meeting. Date: February 26, 2020. Time: 11:00 a.m. to 5:30 p.m. Agenda: To review and evaluate contract proposals. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W032, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Klaus B. Piontek, Ph.D., Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, 9609 Medical Center Drive, Room 7W116, National Cancer Institute, Rockville, MD 20892–9750, 240–276–5413, klaus.piontek@nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Validation of Cancer Markers (UH2/UH3). Date: February 26, 2020. Time: 1:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W240, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Hasan Siddiqui, Ph.D., Scientific Review Officer, Special Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W240, Rockville, MD 20850, 240–276–5122, hasan.siddiqui@ nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Utilizing the PLCO Biospecimens Resources (U01). Date: February 27, 2020. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 7W108, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Clifford W. Schweinfest, Ph.D., Scientific Review Officer, Special Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W108, Bethesda, MD 20892–8329, 240–276–6343, schweinfestcw@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI Predoc to Postdoc Fellow Transition Award (F99/ K00). Date: March 3–4, 2020. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian Blvd., Gaithersburg, MD 20878. Contact Person: Scott A. Chen, Ph.D., Scientific Review Officer, National Cancer Institute, 9609 Medical Center Drive, RM 7W604, Rockville, MD 20850, 240–276–6038, chensc@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI Research Specialist Award (R50). Date: March 5, 2020. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W242, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Zhiqiang Zou, M.D., Ph.D., Scientific Review Officer, Special Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, 7W242, Bethesda, MD 20892, 240–276–6372, zouzhiq@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; SEP–1: NCI Clinical and Translational R21 and Omnibus R03. Date: March 16, 2020. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W606, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Timothy C. Meeker, M.D., Ph.D., Scientific Review Officer, Special Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, 7W606, Rockville, MD 20850, 240–276–6464, meekert@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) E:\FR\FM\30DEN1.SGM 30DEN1

Agencies

[Federal Register Volume 84, Number 249 (Monday, December 30, 2019)]
[Notices]
[Pages 71961-71964]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28141]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5743]


Importation of Certain Food and Drug Administration-Approved 
Human Prescription Drugs, Including Biological Products, Under Section 
801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft 
Guidance for Industry; Availability; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; correction.

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

SUMMARY: This document corrects the Notice of Availability from the 
Food and Drug Administration (FDA, Agency, or we) announcing the 
availability of a draft guidance for industry entitled ``Importation of 
Certain FDA-Approved Human Prescription Drugs, Including Biological 
Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and 
Cosmetic Act,'' which published in the Federal Register on Monday, 
December 23, 2019. This draft guidance describes procedures to obtain a 
National Drug Code (NDC) for an FDA-approved prescription drug that is 
imported into the United States in compliance with the Federal Food, 
Drug, and Cosmetic Act (FD&C Act), which would provide an additional 
avenue through which drugs could be sold at a lower cost in the U.S. 
market. This draft guidance is intended to address certain challenges 
in the private market faced by manufacturers seeking to sell their 
drugs at lower costs. The Notice was published with two omissions. This 
document corrects those omissions by republishing the Notice in its 
entirety to include the omitted language.

DATES: Submit either electronic or written comments on the draft 
guidance by February 21, 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 guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:

[[Page 71962]]

     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-2019-D-5743 for ``Importation of Certain FDA-Approved Human 
Prescription Drugs, Including Biological Products, under Section 
801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act.'' \1\ 
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.
---------------------------------------------------------------------------

    \1\ In the Federal Register of December 23, 2019 (84 FR 70557), 
FDA issued a Notice of Availability for this guidance, the subject 
of this correction notice.
---------------------------------------------------------------------------

     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 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 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: Lyndsay Hennessey, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-7605, 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 ``Importation of Certain FDA-Approved Human Prescription 
Drugs, Including Biological Products, under Section 801(d)(1)(B) of the 
Federal Food, Drug, and Cosmetic Act,'' which, when finalized, will 
represent the Agency's current thinking on the importation of multi-
market approved (MMA) products. This draft guidance describes 
procedures to obtain an NDC for an FDA-approved prescription drug that 
is imported into the United States in compliance with section 801 of 
the FD&C Act (21 U.S.C. 381), which would provide an additional avenue 
through which drugs could be sold at a lower cost in the U.S. market. 
In recent years, FDA has become aware that some drug manufacturers may 
be interested in offering certain of their drugs at lower costs and 
that obtaining additional NDCs for these drugs may help them to address 
certain challenges in the private market. This guidance is not intended 
to address the applicability of the Medicaid drug rebate program for 
manufacturers, which may be addressed in further guidance from other 
components of HHS. This guidance is intended to outline a potential 
pathway by which manufacturers could obtain an additional NDC for an 
FDA-approved drug that was originally intended to be marketed in a 
foreign country. This guidance specifically addresses the importation 
of FDA-approved drugs that were also authorized for sale in a foreign 
country in which the drugs were originally intended to be marketed 
(``MMA product''). This guidance describes: (1) The process for 
submitting a supplement to an approved FDA application for an MMA 
product; (2) the recommended labeling for an MMA product; (3) the 
process for registration and listing and for obtaining an NDC for the 
MMA product; (4) the requirements of section 582 of the FD&C Act (21 
U.S.C. 360eee-1) as added by the Drug Supply Chain Security Act (DSCSA) 
(Title II of Pub. L. 113-54); (5) recommendations related to procedures 
for importation of the MMA product; and (6) other FDA requirements 
applicable to MMA products.
    This guidance, when finalized, will help ensure manufacturers are 
aware of

[[Page 71963]]

procedures to provide access to lower-cost drugs in the United 
States.\2\ The guidance details procedures that will enable 
manufacturers to obtain an additional NDC for the MMA product, which 
could allow greater pricing flexibility for a drug or biological 
product. The additional NDC also will support pharmacovigilance, 
accurate billing and reimbursement, and facilitate clearance of the MMA 
products through customs. This draft guidance is not final nor is it in 
effect at this time.
---------------------------------------------------------------------------

    \2\ In the Federal Register of December 23, 2019 (84 FR 70796), 
FDA issued a Notice of Proposed Rulemaking under 21 U.S.C. 384 to 
offer a pathway for importation of drugs from Canada without the 
authorization of the manufacturer.
---------------------------------------------------------------------------

    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 the 
importation of MMA products. 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.

II. Issues for Consideration

    As previously noted, FDA is interested in receiving comments on the 
draft guidance. Regarding the approach set forth in the draft guidance, 
in addition to any other issues addressed, FDA requests that commenters 
consider the following issues when submitting comments:
    1. Are there additional considerations for certain types of drug 
products with special handling, such as sterile injectables, drugs with 
boxed warnings, drugs with REMS (Risk Evaluation and Mitigation 
Strategy), controlled substances, or drugs that do not meet the 
definition of ``product'' under the DSCSA (21 U.S.C. 360eee(13))? Are 
there additional considerations for combination products related to the 
content of the guidance (e.g., supplement, labeling, NDC) that would 
warrant additional guidance for use of this approach for those 
products? To the extent that interested parties believe that different 
or additional considerations from those described in the draft guidance 
should apply to such an approach for combination products, we are 
interested in input on that, as well.
    2. The draft guidance uses ``MMA product'' to describe FDA-approved 
drugs that were originally intended to be marketed in a foreign country 
and also authorized for sale in that foreign country. Is this new term 
adequate and understandable? Is there another term that would provide 
more clarity regarding the products discussed in the guidance?
    3. The draft guidance describes how an NDC could be obtained for 
MMA products. What is the effect of a manufacturer using a new labeler 
code as opposed to a new product code to distinguish these products, 
such as for reimbursement?
    4. The draft guidance recommends a labeling statement in the FDA-
approved labeling for the MMA product, including the carton and 
container label, to assist pharmacists and others in accurately 
identifying, dispensing, and billing for these products. FDA seeks 
comment on the specific wording that could be included in the statement 
to differentiate MMA products from other drugs that are not the subject 
of the guidance, if finalized, and to help ensure MMA products are 
easily identifiable to pharmacists and not confusing to patients. FDA 
also seeks comment on other types of distinguishing characteristics on 
the carton and container label that would further enable pharmacists to 
identify an MMA product and distinguish it from other packages of the 
FDA-approved drug, without confusing patients and consistent with other 
applicable requirements relating to carton and container labeling. 
Additionally, would other possible mechanisms, such as a Dear 
Healthcare Provider letter, provide further clarity and reduce 
confusion for pharmacists and other healthcare providers as well as 
patients?
    5. We request comment about how much, on average, the labeling and 
packaging changes described in the draft guidance would cost drug 
manufacturers and repackagers or relabelers. Are there other ways to 
distinguish the appearance of an MMA product? We also request comment 
about alternative labeling approaches that would display the required 
information with equal prominence but may result in lower costs.
    6. The draft guidance describes procedures for manufacturers of 
drug products approved under new drug applications or biologics license 
applications to obtain an additional NDC for an MMA product. FDA is 
interested as to whether manufacturers of generic drugs approved under 
an abbreviated new drug application confront similar pricing issues 
such that it would be appropriate to provide guidance on a similar 
approach for generic drugs. To the extent that interested parties 
believe that different considerations should apply to such an approach 
for generic drugs from those described in the draft guidance, input is 
requested on that as well.
    7. There are complex considerations that impact biosimilar 
development, market entry, and uptake. We are interested in the 
possible impacts of MMA products that are biological products on 
biosimilar development, market entry, and uptake.
    8. Similarly, there are complex considerations impacting generic 
drug market entry. We are interested in the possible impacts of MMA 
products on generic drug development and market entry.
    9. Are there voluntary steps a manufacturer may take in addition to 
the requirements in the DSCSA to ensure the security of the supply 
chain for products imported pursuant to the guidance?
    10. Are there any potential risks associated with the importation 
of products as described in the draft guidance that could be addressed 
by a rulemaking? For example, to what extent, if any, are there 
additional procedures that might better protect against entities 
seeking to introduce counterfeit drugs in the United States? If so, 
please be specific about the potential risk and how it could be 
addressed through rulemaking.
    11. The draft guidance describes a pathway that manufacturers could 
use to offer their products to Americans at a lower price. FDA is 
interested in the factors that could contribute to the decision to use 
this pathway and whether there are reasons to use this pathway other 
than the ability to sell products at a lower price.

III. Paperwork Reduction Act of 1995

    FDA has tentatively concluded that there are no new collections of 
information in this draft guidance. This draft guidance refers to 
previously approved collections of information found in the FD&C Act 
and 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. 3501-3521). In accordance with the 
Paperwork Reduction Act, if FDA's tentative conclusion changes, prior 
to publication of any 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 those previously approved collections of 
information found in FDA regulations or guidances.

[[Page 71964]]

    The collections of information in 21 CFR part 314 (new drug 
applications) have been approved under OMB control number 0910-0001; 
the collections of information in 21 CFR part 601 (biologics license 
applications) have been approved under OMB control number 0910-0338; 
the collections of information in 21 CFR part 207 (domestic and foreign 
facility registration, including assignment of an NDC) have been 
approved under OMB control number 0910-0045; the collections of 
information in 21 CFR part 1 (general enforcement regulations) have 
been approved under OMB control number 0910-0046; the collections of 
information in 21 CFR part 201 (labeling) have been approved under OMB 
control number 0910-0572; the collections of information pertaining to 
current good manufacturing practice requirements for finished 
pharmaceuticals and combination products under 21 CFR parts 4, 210, 
211, 610, and 680 have been approved under OMB control numbers 0910-
0139 and 0910-0834; and the collections of information pertaining to 
suspect product identification and notification under section 582 of 
the FD&C Act have been approved under OMB control number 0910-0806.

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: December 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28141 Filed 12-27-19; 8:45 am]
BILLING CODE 4164-01-P