Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution, 59402-59405 [2021-23395]

Download as PDF lotter on DSK11XQN23PROD with NOTICES1 59402 Federal Register / Vol. 86, No. 205 / Wednesday, October 27, 2021 / Notices 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 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 the 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. FOR FURTHER INFORMATION CONTACT: Joyce Yu, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301–796–2894, Fax: 301–847–8533, email: AMDAC@ fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check FDA’s website at https://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will discuss Emergency Use Authorization (EUA) 000108, submitted by Merck & Co. Inc., for emergency use of molnupiravir oral capsules for treatment of mild to moderate COVID– VerDate Sep<11>2014 16:47 Oct 26, 2021 Jkt 256001 19 in adults who are at risk for progressing to severe COVID–19 and/or hospitalization. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting. Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before November 15, 2021, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 4, 2021. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 5, 2021. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Joyce Yu (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/Advisory PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: October 21, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–23384 Filed 10–26–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0742] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by November 26, 2021. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0045. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUMMARY: E:\FR\FM\27OCN1.SGM 27OCN1 Federal Register / Vol. 86, No. 205 / Wednesday, October 27, 2021 / Notices Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution—21 CFR Part 207 lotter on DSK11XQN23PROD with NOTICES1 OMB Control Number 0910–0045— Revision This information collection supports implementation of drug establishment registration and listing requirements governed by FDA. These requirements are set forth in section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360) and section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262) and provide for electronic submission of information. Agency regulations implementing these provisions are found in part 207 (21 CFR part 207) and set forth the scope, applicability, and content of information to be included in submissions. Except as provided in § 207.65 (21 CFR 207.65), all information submitted under part 207 must be transmitted to FDA in an electronic format by using our electronic drug registration and listing system, in a form that we can process, review, and archive. For more information pertaining to drug establishment registration and listing, we invite you to visit our website at: https:// www.fda.gov/drugs/drug-approvalsand-databases/drug-establishmentscurrent-registration-site. We have revised the information collection to include the collection of certain information required by the Coronavirus Aid, Relief, and Economic Security (CARES) Act (Pub. L. 116–136). Section 3112(e) of the CARES Act amended section 510(j) of the FD&C Act to require that registrants under section 510 of the FD&C Act must annually report the amount of each drug listed that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution. Section 510(j) of the FD&C Act, as amended by section 3112(e) of the CARES Act, also authorizes FDA to require that registrants report this information electronically and to require that registrants report this information at the time a public health emergency is declared. To assist respondents to the information collection with the current electronic reporting requirements, we issued the guidance document entitled ‘‘Providing Regulatory Submissions in Electronic Format—Drug Establishment VerDate Sep<11>2014 16:47 Oct 26, 2021 Jkt 256001 Registration and Drug Listing’’ (June 2009), available from our website at: https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/providing-regulatorysubmissions-electronic-format-drugestablishment-registration-and-druglisting. Guidance on the submission of the reporting required under section 510(j) of the FD&C Act, as amended by section 3112(e) of the CARES Act, is included on CDER’s 2021 guidance agenda available from our website at: https://www.fda.gov/media/134778/ download. Agency guidance documents are issued consistent with our good guidance practice regulations in 21 CFR 10.115, which provide for public comment at any time. Registration under part 207: Unless otherwise exempt under section 510(g) of the FD&C Act or 21 CFR 207.13, all manufacturers, repackers, relabelers, and salvagers must register each domestic establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, and each foreign establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug that is imported or offered for import into the United States. When operations are conducted at more than one establishment and common ownership and control among all the establishments exists, the parent, subsidiary, or affiliate company may submit registration information for all establishments. Private label distributors who do not also manufacture, repack, relabel, or salvage drugs are not required to register under part 207. We will accept registration or listing information submitted by a private label distributor only if the distributor is acting as an authorized agent for and submitting information that pertains to an establishment that manufactures, repacks, relabels, or salvages drugs. Listing requirements under part 207: Under § 207.41 (21 CFR 207.41), registrants must list each drug that it manufactures, repacks, relabels, or salvages for commercial distribution. Each domestic registrant must list each such drug regardless of whether the drug enters interstate commerce. When operations are conducted at more than one establishment, and common PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 59403 ownership and control exists among all the establishments, the parent, subsidiary, or affiliate company may submit listing information for any drug manufactured, repacked, relabeled, or salvaged at any such establishment. A drug manufactured, repacked, or relabeled for private label distribution must be listed in accordance with the requirements in § 207.41(c). In the Federal Register of May 10, 2021 (86 FR 24871), we published a 60day notice requesting public comment on the proposed collection of information. FDA received one comment about reporting provisions newly established by section 3112(e) of the CARES Act. Specifically, the comment questioned the utility of information submitted by respondents who have limited knowledge of the marketing of products and also recommended that FDA limit reporting by certain respondents to final retail packages intended to be marketed. We appreciate this comment and note that we will consider the utility of this information as we continue to implement the information collection. No comments were received requesting that FDA revise its estimate of burden associated with the information collection. On our own initiative, we have downwardly revised the burden estimate found in our 60-day notice regarding reporting elements associated with reporting requirements under section 510(j) of the FD&C Act. Section 510(j) provides for certain exemptions from these reporting requirements. Specifically, section 510(j)(3)(B) of the FD&C Act authorizes the Secretary of Health and Human Services, by order, to exempt from some or all of these reporting requirements certain biological products or categories of biological products regulated under section 351 of the PHS Act if the Secretary determines that such reporting is not necessary to protect the public health. Elsewhere in this issue of the Federal Register, FDA is issuing a proposed order that, if finalized, would exempt the following two categories of biological products from such reporting requirements: (1) Blood and blood components for transfusion, and (2) cell and gene therapy products, where one lot treats a single patient. We estimate the burden of the information collection as follows: E:\FR\FM\27OCN1.SGM 27OCN1 59404 Federal Register / Vol. 86, No. 205 / Wednesday, October 27, 2021 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Initial establishment registration; §§ 207.17, 207.21, and 207.25. Annual review and update of registration information (including expedited updates); § 207.29. Initial listing (including National Drug Code); §§ 207.33, 207.41, 207.45, 207.49, 207.53, 207.54, and 207.55. June and December review and update (or certification) of listing; §§ 207.35 and 207.57. Waiver requests; § 207.65 .................................... Public disclosure exemption request; § 207.81(c) Manufacturing amount information; CARES Act section 3112. Total ............................................................... 1 There Number of responses per respondent Number of respondents Activity; 21 CFR section/statutory citation Total annual responses Average burden per response Total hours 1,480 2 2,960 1 .................................... 2,960 10,000 1 10,000 0.5 (30 minutes) ........... 5,000 1,713 7.28 12,470 1.5 ................................. 18,705 5,300 20 106,000 0.75 (45 minutes) ......... 79,500 1 100 11,020 1 1 22.5 1 100 247,950 0.5 (30 minutes) ........... 1 .................................... 0.25 (15 minutes) ......... 1 100 61,988 ........................ ........................ 379,481 ....................................... 168,254 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Guidance recommendation Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Preparing Standard Operating Procedures for Creating and Uploading the Structured Product Labeling File ....... 1,000 1 1,000 40 40,000 lotter on DSK11XQN23PROD with NOTICES1 1 There are no capital costs or operating and maintenance costs associated with this collection of information. According to internal data, we estimate 1,480 respondents will submit 2,960 new establishment registrations annually. We estimate that 10,000 registrants will provide 10,000 annual reviews and updates of registration information (including expedited updates) or reviews and certifications that no changes have occurred. The estimates include the registration of establishments for both domestic and foreign manufacturers, repackers, relabelers, and drug product salvagers, and registration information submitted by anyone acting as an authorized agent for an establishment that manufactures, repacks, relabels, or salvages drugs. The estimates include an additional 80 positron emission tomography drug producers who are not exempt from registration and approximately 30 manufacturers of plasma derivatives. We assume 1 hour is necessary for registrants to submit initial registration information electronically for each new establishment. We assume 30 minutes is necessary for each annual review and update of registration information (including any expedited updates) or each review and certification that no changes have occurred. Our estimate reflects the average amount of time and effort necessary to register a domestic or foreign establishment, and the average amount of time and effort necessary to review and update registration VerDate Sep<11>2014 16:47 Oct 26, 2021 Jkt 256001 information, or review registration information and certify no changes have occurred. Based on the number of drugs listed annually since June 2009, we estimate 1,713 registrants will report approximately 12,469 new listings annually (including the information submitted to obtain a labeler code and to reserve a National Drug Code (NDC) for future use). Based on the number of drugs in our listing database and the current number of changes to listing information submitted, we estimate 5,300 registrants will each report 20 reviews and updates (including the information submitted to revise an NDC) for a total of 106,000 annually. The estimates for the number of drug listings include both domestic and foreign listings, listings submitted by registrants for products sold under their own names as well as products intended for private label distribution, and information submitted related to an NDC and to obtain a labeler code. The estimate for the number of drugs subject to the listing requirements includes positron emission tomography drugs and approximately 30 plasma derivatives. The estimates for the number of June and December reviews and updates of listing information include the number of changes to drug characteristics pertaining to the drug product code to obtain a new NDC and PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 the reports of the withdrawal of an approved drug from sale under § 314.81(b)(3)(iii) (21 CFR 314.81(b)(3)(iii)). Based on our experience with electronically listing submissions since June 2009, we assume it takes 1 hour and 30 minutes to submit information electronically for each drug listed for the first time (for both foreign and domestic registrant listings). These estimates are an average of the time it will take manufacturers, repackers, relabelers, and drug product salvagers, with drug product salvagers taking considerably less time than manufacturers. The estimates include the time for submitting the content of labeling and other labeling in an electronic format (for drugs subject to an approved marketing application, the electronic submission of the content of labeling under 21 CFR 314.50(l)(1)(i) is approved under OMB control number 0910–0001). We assume it takes 45 minutes for each June and December review and update. These estimates represent the average amount of time to review and update listing information or to review and certify that no changes have occurred. The estimates include the time for submitting any labeling for each drug, changes to the drug’s characteristics submitted for a new NDC, and reports of the withdrawal of E:\FR\FM\27OCN1.SGM 27OCN1 Federal Register / Vol. 86, No. 205 / Wednesday, October 27, 2021 / Notices an approved drug from sale under § 314.81(b)(3)(iii). We estimate 1,000 firms will expend 40 hours to prepare, review, and approve a standard operating procedure (SOP), for a total of 40,000 hours annually. Although we expect most respondents will have already prepared and implemented an SOP for the electronic submission of drug establishment registration and drug listing information, we retain an estimate for new firms that will do so, as recommended in the guidance. Finally, we estimate 12,800 respondents are now subject to the reporting provisions introduced by the CARES Act under section 3112(e), and assume it will take 15 minutes to prepare and submit the requisite information, as shown in our 60-day notice. However, we have reduced this figure by 1,780 to 11,020 to reflect proposed reporting exemptions pertaining to: (1) Blood and blood components for transfusion and (2) cell and gene therapy products, where one lot treats a single patient. Consistent with section 510(j)(3)(B) of the FD&C Act, we have proposed to exempt these biological product categories from the reporting requirements in section 510(j)(3)(A) of the FD&C Act. If our proposed order is not finalized, we will adjust our estimate accordingly upon reevaluation of the information collection. Overall, the information collection reflects an increase which we attribute to the new reporting required by section 510(j) of the FD&C Act, as amended by the CARES Act. We have otherwise retained the currently approved burden estimates for the provisions in part 207. Dated: October 21, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–23395 Filed 10–26–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–0026] lotter on DSK11XQN23PROD with NOTICES1 Issuance of Priority Review Voucher; Rare Pediatric Disease Product AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease SUMMARY: VerDate Sep<11>2014 16:47 Oct 26, 2021 Jkt 256001 product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that RETHYMIC (allogeneic processed thymus tissue-agdc), manufactured by Enzyvant Therapeutics, GmbH, meets the criteria for a priority review voucher. FOR FURTHER INFORMATION CONTACT: Myrna Hanna, 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. FDA is announcing the issuance of a priority review voucher to the sponsor of an approved rare pediatric disease product application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), FDA will award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined that RETHYMIC (allogeneic processed thymus tissue-agdc), manufactured by Enzyvant Therapeutics, GmbH, meets the criteria for a priority review voucher. RETHYMIC (allogeneic processed thymus tissue-agdc) is indicated for immune reconstitution in pediatric patients with congenital athymia. RETHYMIC (allogeneic processed thymus tissue-agdc) is not indicated for the treatment of patients with severe combined immunodeficiency (SCID). For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to https://www.fda.gov/industry/ developing-products-rare-diseasesconditions/rare-pediatric-disease-rpddesignation-and-voucher-programs. For further information about RETHYMIC (allogeneic processed thymus tissueagdc), go to the Center for Biologics Evaluation and Research Cellular and Gene Therapy Products website at https://www.fda.gov/vaccines-bloodbiologics/cellular-gene-therapyproducts/approved-cellular-and-genetherapy-products. SUPPLEMENTARY INFORMATION: Dated: October 19, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–23336 Filed 10–26–21; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 59405 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; 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 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, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: In Toxicology, Pharmacology and Hepatology. Date: December 2, 2021. Time: 9:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Santanu Banerjee, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2106, Bethesda, MD 20892, (301) 435–5947, banerjees5@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Special Topics in Nephrology and Urology. Date: December 2, 2021. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Stacey Nicole Williams, Ph.D., Scientific Review Officer, Center for Scientific Review, 6701 Rockledge Drive, Bethesda, MD 20892, 301–867–5309, stacey.williams@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Cancer Genomics. Date: December 2, 2021. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Jian Cao, M.D., Scientific Review Officer, Center for Scientific Review, 6701 Rockledge Drive, Room 4196, MSC 7844, Bethesda, MD 20892, (301) 827–5902, caojn@csr.nih.gov. E:\FR\FM\27OCN1.SGM 27OCN1

Agencies

[Federal Register Volume 86, Number 205 (Wednesday, October 27, 2021)]
[Notices]
[Pages 59402-59405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23395]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0742]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Registration of 
Producers of Drugs and Listing of Drugs in Commercial Distribution

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by November 26, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0045. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

[[Page 59403]]

Registration of Producers of Drugs and Listing of Drugs in Commercial 
Distribution--21 CFR Part 207

OMB Control Number 0910-0045--Revision

    This information collection supports implementation of drug 
establishment registration and listing requirements governed by FDA. 
These requirements are set forth in section 510 of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360) and section 351 of 
the Public Health Service (PHS) Act (42 U.S.C. 262) and provide for 
electronic submission of information. Agency regulations implementing 
these provisions are found in part 207 (21 CFR part 207) and set forth 
the scope, applicability, and content of information to be included in 
submissions. Except as provided in Sec.  207.65 (21 CFR 207.65), all 
information submitted under part 207 must be transmitted to FDA in an 
electronic format by using our electronic drug registration and listing 
system, in a form that we can process, review, and archive. For more 
information pertaining to drug establishment registration and listing, 
we invite you to visit our website at: https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishments-current-registration-site.
    We have revised the information collection to include the 
collection of certain information required by the Coronavirus Aid, 
Relief, and Economic Security (CARES) Act (Pub. L. 116-136). Section 
3112(e) of the CARES Act amended section 510(j) of the FD&C Act to 
require that registrants under section 510 of the FD&C Act must 
annually report the amount of each drug listed that was manufactured, 
prepared, propagated, compounded, or processed by such person for 
commercial distribution. Section 510(j) of the FD&C Act, as amended by 
section 3112(e) of the CARES Act, also authorizes FDA to require that 
registrants report this information electronically and to require that 
registrants report this information at the time a public health 
emergency is declared.
    To assist respondents to the information collection with the 
current electronic reporting requirements, we issued the guidance 
document entitled ``Providing Regulatory Submissions in Electronic 
Format--Drug Establishment Registration and Drug Listing'' (June 2009), 
available from our website at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-drug-establishment-registration-and-drug-listing. Guidance on the submission of the reporting required under 
section 510(j) of the FD&C Act, as amended by section 3112(e) of the 
CARES Act, is included on CDER's 2021 guidance agenda available from 
our website at: https://www.fda.gov/media/134778/download. Agency 
guidance documents are issued consistent with our good guidance 
practice regulations in 21 CFR 10.115, which provide for public comment 
at any time.
    Registration under part 207: Unless otherwise exempt under section 
510(g) of the FD&C Act or 21 CFR 207.13, all manufacturers, repackers, 
relabelers, and salvagers must register each domestic establishment 
that manufactures, repacks, relabels, or salvages a drug, or an animal 
feed bearing or containing a new animal drug, and each foreign 
establishment that manufactures, repacks, relabels, or salvages a drug, 
or an animal feed bearing or containing a new animal drug that is 
imported or offered for import into the United States. When operations 
are conducted at more than one establishment and common ownership and 
control among all the establishments exists, the parent, subsidiary, or 
affiliate company may submit registration information for all 
establishments. Private label distributors who do not also manufacture, 
repack, relabel, or salvage drugs are not required to register under 
part 207. We will accept registration or listing information submitted 
by a private label distributor only if the distributor is acting as an 
authorized agent for and submitting information that pertains to an 
establishment that manufactures, repacks, relabels, or salvages drugs.
    Listing requirements under part 207: Under Sec.  207.41 (21 CFR 
207.41), registrants must list each drug that it manufactures, repacks, 
relabels, or salvages for commercial distribution. Each domestic 
registrant must list each such drug regardless of whether the drug 
enters interstate commerce. When operations are conducted at more than 
one establishment, and common ownership and control exists among all 
the establishments, the parent, subsidiary, or affiliate company may 
submit listing information for any drug manufactured, repacked, 
relabeled, or salvaged at any such establishment. A drug manufactured, 
repacked, or relabeled for private label distribution must be listed in 
accordance with the requirements in Sec.  207.41(c).
    In the Federal Register of May 10, 2021 (86 FR 24871), we published 
a 60-day notice requesting public comment on the proposed collection of 
information. FDA received one comment about reporting provisions newly 
established by section 3112(e) of the CARES Act. Specifically, the 
comment questioned the utility of information submitted by respondents 
who have limited knowledge of the marketing of products and also 
recommended that FDA limit reporting by certain respondents to final 
retail packages intended to be marketed. We appreciate this comment and 
note that we will consider the utility of this information as we 
continue to implement the information collection. No comments were 
received requesting that FDA revise its estimate of burden associated 
with the information collection.
    On our own initiative, we have downwardly revised the burden 
estimate found in our 60-day notice regarding reporting elements 
associated with reporting requirements under section 510(j) of the FD&C 
Act. Section 510(j) provides for certain exemptions from these 
reporting requirements. Specifically, section 510(j)(3)(B) of the FD&C 
Act authorizes the Secretary of Health and Human Services, by order, to 
exempt from some or all of these reporting requirements certain 
biological products or categories of biological products regulated 
under section 351 of the PHS Act if the Secretary determines that such 
reporting is not necessary to protect the public health. Elsewhere in 
this issue of the Federal Register, FDA is issuing a proposed order 
that, if finalized, would exempt the following two categories of 
biological products from such reporting requirements: (1) Blood and 
blood components for transfusion, and (2) cell and gene therapy 
products, where one lot treats a single patient.
    We estimate the burden of the information collection as follows:

[[Page 59404]]



                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
   Activity; 21 CFR section/       Number of     responses per   Total annual    Average burden     Total hours
      statutory citation          respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Initial establishment                    1,480               2           2,960  1...............           2,960
 registration; Sec.  Sec.
 207.17, 207.21, and 207.25.
Annual review and update of             10,000               1          10,000  0.5 (30 minutes)           5,000
 registration information
 (including expedited
 updates); Sec.   207.29.
Initial listing (including               1,713            7.28          12,470  1.5.............          18,705
 National Drug Code); Sec.
 Sec.   207.33, 207.41,
 207.45, 207.49, 207.53,
 207.54, and 207.55.
June and December review and             5,300              20         106,000  0.75 (45                  79,500
 update (or certification) of                                                    minutes).
 listing; Sec.  Sec.   207.35
 and 207.57.
Waiver requests; Sec.   207.65               1               1               1  0.5 (30 minutes)               1
Public disclosure exemption                100               1             100  1...............             100
 request; Sec.   207.81(c).
Manufacturing amount                    11,020            22.5         247,950  0.25 (15                  61,988
 information; CARES Act                                                          minutes).
 section 3112.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............         379,481  ................         168,254
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                       Average burden
                      Guidance recommendation                           Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparing Standard Operating Procedures for Creating and Uploading            1,000                1            1,000               40           40,000
 the Structured Product Labeling File..............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    According to internal data, we estimate 1,480 respondents will 
submit 2,960 new establishment registrations annually. We estimate that 
10,000 registrants will provide 10,000 annual reviews and updates of 
registration information (including expedited updates) or reviews and 
certifications that no changes have occurred. The estimates include the 
registration of establishments for both domestic and foreign 
manufacturers, repackers, relabelers, and drug product salvagers, and 
registration information submitted by anyone acting as an authorized 
agent for an establishment that manufactures, repacks, relabels, or 
salvages drugs. The estimates include an additional 80 positron 
emission tomography drug producers who are not exempt from registration 
and approximately 30 manufacturers of plasma derivatives.
    We assume 1 hour is necessary for registrants to submit initial 
registration information electronically for each new establishment. We 
assume 30 minutes is necessary for each annual review and update of 
registration information (including any expedited updates) or each 
review and certification that no changes have occurred. Our estimate 
reflects the average amount of time and effort necessary to register a 
domestic or foreign establishment, and the average amount of time and 
effort necessary to review and update registration information, or 
review registration information and certify no changes have occurred.
    Based on the number of drugs listed annually since June 2009, we 
estimate 1,713 registrants will report approximately 12,469 new 
listings annually (including the information submitted to obtain a 
labeler code and to reserve a National Drug Code (NDC) for future use). 
Based on the number of drugs in our listing database and the current 
number of changes to listing information submitted, we estimate 5,300 
registrants will each report 20 reviews and updates (including the 
information submitted to revise an NDC) for a total of 106,000 
annually. The estimates for the number of drug listings include both 
domestic and foreign listings, listings submitted by registrants for 
products sold under their own names as well as products intended for 
private label distribution, and information submitted related to an NDC 
and to obtain a labeler code. The estimate for the number of drugs 
subject to the listing requirements includes positron emission 
tomography drugs and approximately 30 plasma derivatives. The estimates 
for the number of June and December reviews and updates of listing 
information include the number of changes to drug characteristics 
pertaining to the drug product code to obtain a new NDC and the reports 
of the withdrawal of an approved drug from sale under Sec.  
314.81(b)(3)(iii) (21 CFR 314.81(b)(3)(iii)).
    Based on our experience with electronically listing submissions 
since June 2009, we assume it takes 1 hour and 30 minutes to submit 
information electronically for each drug listed for the first time (for 
both foreign and domestic registrant listings). These estimates are an 
average of the time it will take manufacturers, repackers, relabelers, 
and drug product salvagers, with drug product salvagers taking 
considerably less time than manufacturers. The estimates include the 
time for submitting the content of labeling and other labeling in an 
electronic format (for drugs subject to an approved marketing 
application, the electronic submission of the content of labeling under 
21 CFR 314.50(l)(1)(i) is approved under OMB control number 0910-0001). 
We assume it takes 45 minutes for each June and December review and 
update. These estimates represent the average amount of time to review 
and update listing information or to review and certify that no changes 
have occurred. The estimates include the time for submitting any 
labeling for each drug, changes to the drug's characteristics submitted 
for a new NDC, and reports of the withdrawal of

[[Page 59405]]

an approved drug from sale under Sec.  314.81(b)(3)(iii).
    We estimate 1,000 firms will expend 40 hours to prepare, review, 
and approve a standard operating procedure (SOP), for a total of 40,000 
hours annually. Although we expect most respondents will have already 
prepared and implemented an SOP for the electronic submission of drug 
establishment registration and drug listing information, we retain an 
estimate for new firms that will do so, as recommended in the guidance.
    Finally, we estimate 12,800 respondents are now subject to the 
reporting provisions introduced by the CARES Act under section 3112(e), 
and assume it will take 15 minutes to prepare and submit the requisite 
information, as shown in our 60-day notice. However, we have reduced 
this figure by 1,780 to 11,020 to reflect proposed reporting exemptions 
pertaining to: (1) Blood and blood components for transfusion and (2) 
cell and gene therapy products, where one lot treats a single patient. 
Consistent with section 510(j)(3)(B) of the FD&C Act, we have proposed 
to exempt these biological product categories from the reporting 
requirements in section 510(j)(3)(A) of the FD&C Act. If our proposed 
order is not finalized, we will adjust our estimate accordingly upon 
reevaluation of the information collection.
    Overall, the information collection reflects an increase which we 
attribute to the new reporting required by section 510(j) of the FD&C 
Act, as amended by the CARES Act. We have otherwise retained the 
currently approved burden estimates for the provisions in part 207.

    Dated: October 21, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23395 Filed 10-26-21; 8:45 am]
BILLING CODE 4164-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.