Notices. Notice
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/register/2021/02/16/2021-03023·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4164-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2020-N-2030] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Food and Drug Administration Approval To Market a New Drug AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)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 March 18, 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 0910-0001. 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. Application for FDA Approval To Market a New Drug; OMB Control No. 0910-0001—Revision This information collection supports FDA regulations. Under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(a)), a new drug may not be commercially marketed in the United States unless an approval of an application filed with FDA under section 505(b) or
(j)of the FD&C Act is effective with respect to such drug. We have issued regulations in part 314 (21 CFR part 314) to govern procedures and requirements for applications submitted in accordance with section 505. The regulations in subpart A (§§ 314.1 through 314.3) set forth general provisions, while regulations in subparts B and C (§§ 314.50 through 314.99) set forth content and format requirements for new drug applications
(NDAs)and abbreviated new drug applications (ANDAs) respectively. The regulations include requirements for the submission of specific data elements along with patent information, pediatric use information, supplements and amendments, proposed labeling, and specific postmarketing reports. Respondents to the information collection are sponsors of these applications. To assist respondents to the information collection we have developed the following forms: • Form FDA 0356h (and instructions): Application to Market a New or Abbreviated New Drug or Biologic for Human Use; • Form FDA 2252 (and instructions): Transmittal of Annual Reports for Drugs and Biologics For Human Use (§ 314.81); • Form FDA 2253 (and instructions): Transmittal of Advertisements and Promotional Labeling For Drugs and Biologics For Human Use; and • Forms FDA 3331/3331a: Field Alert Report and Instruction • Forms FDA 3542 and 3542a and Instructions: Patent Information Submitted *Upon and After Approval* of an NDA Supplement; Patent Information Submitted *With the Filing* of an NDA, Amendment, or Supplement • New Draft Form FDA 3898 and Instruction: Drug Master File Individuals requesting printed forms are instructed to contact the FDA Forms Manager by email at *formsmanager@OC.FDA.GOV.* Certain fees may be applicable. Regulations in subpart D (§§ 314.100 through 314.170) explain Agency actions on applications and set forth timeframes for FDA review. We are revising the information collection to include provisions established through our Agency user fee programs, most recently authorized under the FDA Reauthorization Act of 2017. These provisions pertain to review transparency, communications with FDA, dispute resolution, drug safety enhancements, and the allocation of Agency resources to align with these program objectives as agreed to with our stakeholders and set forth in our “Performance Goals for Fiscal Years 2018-2022” Commitment Letters, which are available from our website at *https://www.fda.gov* along with more information about FDA user fee programs. Information collection pertaining to hearing and other administrative proceedings covered in 21 CFR subpart E are approved under OMB control no. 0910-0191. Unless otherwise noted, information collection pertaining to postmarket safety reporting and associated recordkeeping is approved under OMB control nos. 0910-0230, 0910-0291, and 0910-0645. Included among the miscellaneous provisions in subpart G (§§ 314.410 to 314.445), § 314.420 covers information to include in drug master files (DMFs). To assist respondents to this information collection we have prepared templates and resources available from our website at *www.fda.gov/drugs/forms-submission-requirements/drug-master-files-dmfs.* As noted above, we have developed new Form FDA 3898 and accompanying instructions on submitting DMFs in accordance with the applicable regulations. In accordance with § 314.445, we also develop Agency guidance documents to assist respondents in complying with provisions in part 314. These guidance documents are issued consistent with our good guidance practice regulations at § 10.115. To search available FDA guidance documents, visit our website at *https://www.fda.gov/regulatory-information/search-fda-guidance-documents.* Finally, applications submitted in accordance with subpart H (§§ 314.500 through 314.560) pertain to accelerated approval of new drugs for serious or life-threatening illness, and submissions in subpart I (§§ 314.600 through 314.650) pertain to approval of new drugs when human efficacy studies are not ethical or feasible. The regulations provide for the submission of specific data elements along with promotional material. We use the information collection to approve drugs shown to be safe and effective and to implement effective public health monitoring systems. We also use product approval and related patent and exclusivity information to publish the “Approved Drug Products with Therapeutic Equivalence Evaluations” list (the Orange Book). More information regarding the Orange Book is available from our website at *https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book.* In the **Federal Register** of November 16, 2020 (85 FR 73057), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received and we have therefore made no adjustments to our estimate, which is as follows: Table 1—Estimated Annual Reporting Burden 21 CFR section Number of respondents Number of responses per respondent Total annual responses Average burden per response (in hours) Total hours Subpart B 314.50(a)-(l)—Content and format of a 505(b)(1) or 505(b)(2) application 121 1.15 139 1,921 267,019 314.50(i)(1)—patent certifications: Form FDA 3542 281 2.875 808 10 8,080 Form FDA 3542a 310 2.084 646 15 9,690 314.50(i)(6) amended patent certifications 17 1 17 2 34 314.52(a), (b), and (e)—NDAs—notice of noninfringement of patent certification 15 3 45 15 675 314.52(c)—Noninfringement of patent certification notice content 22 3 66 0.33 (20 minutes) 22 314.53(f)(1)—Correction of patent information errors by persons other than the NDA holder 24 1 24 10 240 314.53(f)(2)—Correction of patent information errors by the NDA holder 28 1.4 39 1 39 314.60—Amendments to unapproved NDA, supplement or resubmission 256 8.23 2,106 80 168,480 314.60(f)—patent certifications for unapproved applications 6 1 6 2 12 314.65—Withdrawal of unapproved applications 14 1.21 17 2 34 314.70 and 314.71—Supplements and other changes to approved application 492 6.57 3,232 150 484,800 314.72—Changes of ownership of NDAs 67 1.45 97 2 194 314.81—Other postmarketing reports 314.81(b)(1) [3331 and 3331a field alert reports and followups] 484 20.3 9,834 8 78,672 314.81(b)(2)[2252]—Annual reports 626 4.9 3,066 40 122,640 314.81(b)(2)[2253]—Promotional labeling 331 141.3 46,782 2 93,564 Subpart C 314.94(a)and(d)—ANDA content 229 4.3 987 480 473,760 314.94(a)(12)(viii) amended patent certifications before approval of ANDA 153 1 153 2 306 314.95(c)—Non-infringement of patents (ANDAs) 400 3 1,200 0.33 (20 minutes) 400 314.96(a)(1)—Amendments to unapproved ANDAs 451 36.2 16,311 80 1,304,880 314.96(c) amendment for pharmaceutical equivalent to a listed drug other than RLD 1 1 1 300 300 314.96(d)—patent certification requirements 100 1 100 2 200 314.97—Supplements and other changes to ANDAs 361 22.8 8,237 80 658,960 314.97(b) Supplements to ANDA for pharmaceutical equivalent to a listed drug other than RLD 1 1 1 300 300 314.99(a)—ANDA Applicants: Withdrawal of unapproved ANDAs 77 2.3 177 2 354 314.99(a)—ANDA Transfer of ownership 135 1.24 167 2 334 Subpart D 314.101(a)—NDA or ANDA filing over protest 1 1 1 0.5 (30 minutes) 0.5 314.107(e)—notification of court actions or written consent to approval 247 2 494 0.5 (30 minutes) 247 Subparts G, H, and I 314.420—drug master files [FDA 3938]—original amendments 36 27.2 981 61 59,841 DMFs—technical, administrative, REMS) 2,946 11.4 33,590 8 268,720 DMFs—annual reports 2,946 3.33 9,834 4 39,336 314.550—Promotional material and subpart H applications 55 11.6 640 120 76,800 Total 4,118,933.5 Our estimated burden for the information collection reflects a decrease. We attribute this adjustment to improved operational efficiencies with regard to Agency data systems and digital submission processes. Dated: February 8, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021-03023 Filed 2-12-21; 8:45 am]
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