Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability, 60249-60251 [2021-23722]

Download as PDF Federal Register / Vol. 86, No. 208 / Monday, November 1, 2021 / Notices 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, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301–796–3600. SUPPLEMENTARY INFORMATION: lotter on DSK11XQN23PROD with NOTICES1 I. Background The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved for marketing the human drug product SPINRAZA (nusinersen sodium). SPINRAZA is indicated for the treatment of spinal muscular atrophy in pediatric and adult patients. Subsequent to this approval, the USPTO received patent term restoration applications for SPINRAZA (U.S. Patent Nos. 7,838,657 and 8,110,560 from University of Massachusetts, and U.S. Patent Nos. 8,361,977 and 8,980,853 from Biogen VerDate Sep<11>2014 18:03 Oct 29, 2021 Jkt 256001 MA Inc., and Cold Spring Harbor Laboratory), and the USPTO requested FDA’s assistance in determining the patents’ eligibility for patent term restoration. In a letter dated February 8, 2018, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of SPINRAZA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for SPINRAZA is 1,891 days. Of this time, 1,799 days occurred during the testing phase of the regulatory review period, while 92 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: October 22, 2011. FDA has verified the applicants’ claims that the date the investigational new drug application became effective was on October 22, 2011. 2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: September 23, 2016. FDA has verified the applicants’ claims that the new drug application (NDA) for SPINRAZA (NDA 209531) was initially submitted on September 23, 2016. 3. The date the application was approved: December 23, 2016. FDA has verified the applicants’ claims that NDA 209531 was approved on December 23, 2016. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, these applicants seek 29 days, 210 days, 937 days, or 992 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 60249 comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: October 26, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–23719 Filed 10–29–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–D–1031] Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act.’’ This draft guidance addresses the process through which registrants of drug establishments should submit to FDA reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act). DATES: Submit either electronic or written comments on the draft guidance by January 3, 2022 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: E:\FR\FM\01NON1.SGM 01NON1 60250 Federal Register / Vol. 86, No. 208 / Monday, November 1, 2021 / Notices 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’’). lotter on DSK11XQN23PROD with NOTICES1 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– 2021–D–1031 for ‘‘Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act.’’ 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, 240–402–7500. • 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 VerDate Sep<11>2014 18:03 Oct 29, 2021 Jkt 256001 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, 240–402–7500. 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; Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Room 3128, Silver Spring, MD 20993–0002; or Policy and Regulations Staff, HFV–6, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855. 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: Neil Stiber, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 Ave., Bldg. 51, Rm. 4128, Silver Spring, MD 20993–0002, 301–796–8944; 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; Neal Bataller, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, (HFV–210), Rm. 2612, Rockville, MD 20855, 240–402–5745. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act.’’ On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was enacted to aid response efforts and ease the economic impact of the Coronavirus Disease 2019 (COVID–19). In addition, the CARES Act included authorities to enhance FDA’s ability to identify, prevent, and mitigate possible drug shortages by, among other things, improving FDA’s visibility into drug supply chains. Section 3112(e) of the CARES Act (Pub. L. 116–136) added section 510(j)(3) of the FD&C Act (21 U.S.C. 360(j)(3)) to require that each person (including repackers and relabelers) who registers with FDA under section 510 of the FD&C Act with regard to a drug must report annually to FDA the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution. This draft guidance is intended to assist registrants of drug establishments in submitting to FDA reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of the FD&C Act. The draft guidance addresses the content of reports, the timing of reports, and the process for report submission. This draft guidance describes the process that should be used for reporting by each person who registers with FDA under section 510 of the FD&C Act with regard to a listed drug (including a finished dosage form product, an active pharmaceutical ingredient, and other listed drugs), except for biological products or categories thereof exempted by an order under section 510(j)(3)(B)). The process described in this guidance applies to such reporting with respect to listed drugs, including medical gases, homeopathic products, products E:\FR\FM\01NON1.SGM 01NON1 Federal Register / Vol. 86, No. 208 / Monday, November 1, 2021 / Notices marketed in accordance with requirements under section 505G of the FD&C Act (21 U.S.C. 355h), often referred to as over-the-counter monograph drugs, and animal drug products that are not approved, conditionally approved, or indexed under sections 512, 571, and 572 of the FD&C Act (21 U.S.C. 360b, 360ccc, and 360ccc–1). 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 ‘‘Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act.’’ 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. compound, or process. Registrants must submit information on the following listed drugs: (1) Finished dosage form products, (2) drug products with active pharmaceutical ingredients, and (3) other listed drugs. The collection of information under section 510(j)(3) of the FD&C Act (as added by section 3112 of the CARES Act) on the amount of listed drug products has been approved under OMB control number 0910–0045. FDA is developing an electronic portal for registrants to submit this information. • FDA requires that applicants submit annual reports for abbreviated new drug applications, biologics license applications, and new drug applications. The collections of information in parts 314 and 601 have been approved under OMB control numbers 0910–0001 and 0910–0338. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The regulatory citations and associated collections of information that OMB approved are as follows: • Registrants who own or operate a domestic or foreign establishment that manufactures, prepares, propagates, compounds, or processes a drug must submit to FDA information on the amount of listed drugs that they manufacture, prepare, propagate, III. Electronic Access Dated: October 27, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–23722 Filed 10–29–21; 8:45 am] BILLING CODE 4164–01–P Application No. Drug NDA 007409 ...... NDA 014169 ...... Bentyl (dicyclomine hydrochloride (HCl)) Capsules, 10 milligram (mg). Bentyl (dicyclomine HCl) Tablets, 20 mg. Norinyl 1 + 50 (norethindrone and mestranol) Tablets, 0.05 mg/1 mg. Norinyl (norethindrone and mestranol) Tablets, 0.1 mg/2 mg Dendrid (idoxuridine) Ophthalmic Solution, 0.1% .................... NDA 019404 ...... NDA 019784 ...... Ocufen (flurbiprofen sodium) Ophthalmic Solution, 0.03% ..... Ibuprofen Oral Suspension, 100 mg/5 milliliters (mL) ............. NDA 020010 ...... Lotrisone (betamethasone dipropionate and clotrimazole) Lotion, Equivalent to (EQ) 0.05% base/1%. NDA 020098 ...... Mivacron (mivacurium chloride) Solution, EQ 2 mg base/mL, EQ 10 mg base/5 mL, and EQ 20 mg base/10 mL. Mivacron in Dextrose 5% in plastic container (mivacurium chloride) Injectable, EQ 0.5 mg base/mL and EQ 50 mg base/100 mL. Zerit (stavudine) Capsules, 5 mg, 15 mg, 20 mg, 30 mg, and 40 mg. NDA 013625 ...... lotter on DSK11XQN23PROD with NOTICES1 Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https:// www.fda.gov/animal-veterinary/ guidance-regulations/guidanceindustry, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. NDA 020412 ...... VerDate Sep<11>2014 18:03 Oct 29, 2021 Jkt 256001 PO 00000 60251 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–1071] Allergan Sales, LLC, et al.; Withdrawal of Approval of 18 New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is withdrawing approval of 18 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of December 1, 2021. FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993–0002, 301– 796–3137. SUPPLEMENTARY INFORMATION: The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. SUMMARY: Applicant Frm 00054 Fmt 4703 Sfmt 4703 Allergan Sales, LLC, 5 Giralda Farms, Madison, NJ 07940. Actavis Laboratories UT, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 145 Brandywine Pkwy., West Chester, PA 19380. Alcon Laboratories, Inc., 6201 South Freeway, Fort Worth, TX 76134. Allergan, Inc., 2525 Dupont Dr., Irvine, CA 92612. Abbott Laboratories Established Pharmaceuticals Products Division, 200 Abbott Park Rd., Abbott Park, IL 60064. Merck Sharp and Dohme Corp., a subsidiary of Merck and Co., Inc., 1 Merck Drive, P.O. Box 100, Whitehouse Station, NJ 08889. AbbVie, Inc., 1 N Waukegan Rd., North Chicago, IL 60064 Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543. E:\FR\FM\01NON1.SGM 01NON1

Agencies

[Federal Register Volume 86, Number 208 (Monday, November 1, 2021)]
[Notices]
[Pages 60249-60251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23722]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-1031]


Reporting Amount of Listed Drugs and Biological Products Under 
Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; 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 ``Reporting 
Amount of Listed Drugs and Biological Products Under Section 510(j)(3) 
of the FD&C Act.'' This draft guidance addresses the process through 
which registrants of drug establishments should submit to FDA reports 
on the amount of each listed drug manufactured, prepared, propagated, 
compounded, or processed for commercial distribution, as required by 
the Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: Submit either electronic or written comments on the draft 
guidance by January 3, 2022 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:

[[Page 60250]]

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-2021-D-1031 for ``Reporting Amount of Listed Drugs and Biological 
Products Under Section 510(j)(3) of the FD&C Act.'' 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, 240-402-7500.
     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, 240-402-7500.
    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; Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Room 3128, Silver Spring, MD 20993-0002; or 
Policy and Regulations Staff, HFV-6, Center for Veterinary Medicine, 
Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855. 
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: Neil Stiber, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4128, Silver Spring, MD 20993-0002, 301-
796-8944; 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; Neal Bataller, Center 
for Veterinary Medicine, Food and Drug Administration, 7519 Standish 
Place, (HFV-210), Rm. 2612, Rockville, MD 20855, 240-402-5745.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Reporting Amount of Listed Drugs and Biological Products 
Under Section 510(j)(3) of the FD&C Act.'' On March 27, 2020, the 
Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was 
enacted to aid response efforts and ease the economic impact of the 
Coronavirus Disease 2019 (COVID-19). In addition, the CARES Act 
included authorities to enhance FDA's ability to identify, prevent, and 
mitigate possible drug shortages by, among other things, improving 
FDA's visibility into drug supply chains. Section 3112(e) of the CARES 
Act (Pub. L. 116-136) added section 510(j)(3) of the FD&C Act (21 
U.S.C. 360(j)(3)) to require that each person (including repackers and 
relabelers) who registers with FDA under section 510 of the FD&C Act 
with regard to a drug must report annually to FDA the amount of each 
listed drug that was manufactured, prepared, propagated, compounded, or 
processed by such person for commercial distribution.
    This draft guidance is intended to assist registrants of drug 
establishments in submitting to FDA reports on the amount of each 
listed drug manufactured, prepared, propagated, compounded, or 
processed for commercial distribution, as required by section 510(j)(3) 
of the FD&C Act. The draft guidance addresses the content of reports, 
the timing of reports, and the process for report submission.
    This draft guidance describes the process that should be used for 
reporting by each person who registers with FDA under section 510 of 
the FD&C Act with regard to a listed drug (including a finished dosage 
form product, an active pharmaceutical ingredient, and other listed 
drugs), except for biological products or categories thereof exempted 
by an order under section 510(j)(3)(B)). The process described in this 
guidance applies to such reporting with respect to listed drugs, 
including medical gases, homeopathic products, products

[[Page 60251]]

marketed in accordance with requirements under section 505G of the FD&C 
Act (21 U.S.C. 355h), often referred to as over-the-counter monograph 
drugs, and animal drug products that are not approved, conditionally 
approved, or indexed under sections 512, 571, and 572 of the FD&C Act 
(21 U.S.C. 360b, 360ccc, and 360ccc-1).
    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 ``Reporting 
Amount of Listed Drugs and Biological Products Under Section 510(j)(3) 
of the FD&C Act.'' 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. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA.
    The regulatory citations and associated collections of information 
that OMB approved are as follows:
     Registrants who own or operate a domestic or foreign 
establishment that manufactures, prepares, propagates, compounds, or 
processes a drug must submit to FDA information on the amount of listed 
drugs that they manufacture, prepare, propagate, compound, or process. 
Registrants must submit information on the following listed drugs: (1) 
Finished dosage form products, (2) drug products with active 
pharmaceutical ingredients, and (3) other listed drugs. The collection 
of information under section 510(j)(3) of the FD&C Act (as added by 
section 3112 of the CARES Act) on the amount of listed drug products 
has been approved under OMB control number 0910-0045. FDA is developing 
an electronic portal for registrants to submit this information.
     FDA requires that applicants submit annual reports for 
abbreviated new drug applications, biologics license applications, and 
new drug applications. The collections of information in parts 314 and 
601 have been approved under OMB control numbers 0910-0001 and 0910-
0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: October 27, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23722 Filed 10-29-21; 8:45 am]
BILLING CODE 4164-01-P
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