Federal Register/Vol. 85, No. 221/Monday

Federal Register / Vol. 85, No. 221 / Monday, November 16, 2020 / Notices 73057

sensitive information is being collected it satisfies the requirements of the ADDRESSES: You may submit comments or used in furtherance of the research. applicable statutes and regulations. as follows. Please note that late, Historically, a CoC generally protected a untimely filed comments will not be II. Paperwork Reduction Act of 1995 researcher from being compelled in a considered. Electronic comments must legal proceeding (such as by subpoena While this guidance contains no be submitted on or before January 15, or court order) to disclose identifiable collection of information, it does refer to 2021. The https://www.regulations.gov and sensitive information about the a previously approved FDA collection of electronic filing system will accept research participant, created or information. Therefore, clearance by the comments until 11:59 p.m. Eastern Time compiled for purposes of the human Office of Management and Budget at the end of January 15, 2021. subject research. The Cures Act (OMB) under the Paperwork Reduction Comments received by mail/hand broadened the protections of the Act of 1995 (PRA) (44 U.S.C. 3501– delivery/courier (for written/paper statutory provision by affirmatively 3521) is not required. The previously submissions) will be considered timely prohibiting holders of CoCs from approved collections of information are if they are postmarked or the delivery disclosing such information unless a subject to review by OMB under the service acceptance receipt is on or specific exception applies. PRA. The collections of information before that date. The Cures Act simplified certain have been approved under OMB control aspects of the issuance of CoCs by number 0910–0130. Electronic Submissions requiring that CoCs be issued for III. Electronic Access Submit electronic comments in the federally funded human subject following way: research that collects or uses Persons with access to the internet • Federal eRulemaking Portal: identifiable, sensitive information may obtain the guidance at either https://www.regulations.gov. Follow the (referred to in the guidance as https://www.fda.gov/ instructions for submitting comments. mandatory CoCs). For non-federally RegulatoryInformation/Guidances/ Comments submitted electronically, funded research, issuance of CoCs is not default.htm or https:// including attachments, to https:// required but may be issued at the www.regulations.gov. www.regulations.gov will be posted to discretion of FDA (referred to in the Dated: November 9, 2020. the docket unchanged. Because your guidance as discretionary CoCs) when Lauren K. Roth, comment will be made public, you are the study involves a product subject to Acting Principal Associate Commissioner for solely responsible for ensuring that your FDA’s jurisdiction and regulatory Policy. comment does not include any authority. FDA intends to continue [FR Doc. 2020–25238 Filed 11–13–20; 8:45 am] confidential information that you or a receiving such requests and will issue BILLING CODE 4164–01–P third party may not wish to be posted, discretionary CoCs as appropriate. This such as medical information, your or guidance is intended to provide anyone else’s Social Security number, or information on how to request a DEPARTMENT OF HEALTH AND confidential business information, such discretionary CoC, the statutory HUMAN SERVICES as a manufacturing process. Please note requirements for requesting such a CoC, that if you include your name, contact and the statutory responsibilities Food and Drug Administration information, or other information that associated with possessing a CoC. [Docket No. FDA–2020–N–2030] identifies you in the body of your Although the mandatory CoC and the comments, that information will be discretionary CoC are issued under Agency Information Collection posted on https://www.regulations.gov. different processes, the protections Activities; Proposed Collection; • If you want to submit a comment afforded by the issuance of either CoC Comment Request; Application for with confidential information that you are identical and the statutory Food and Drug Administration do not wish to be made available to the responsibilities are applicable to both. Approval To Market a New Drug public, submit the comment as a This guidance finalizes the draft written/paper submission and in the guidance entitled ‘‘Certificates of AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper Confidentiality; Guidance for Sponsors, HHS. Submissions’’ and ‘‘Instructions’’). Sponsor-Investigators, Researchers, ACTION: Notice. Industry, and Food and Drug Written/Paper Submissions Administration Staff’’ issued on SUMMARY: The Food and Drug Submit written/paper submissions as November 25, 2019 (84 FR 64906). FDA Administration (FDA or Agency) is follows: considered comments received on the announcing an opportunity for public • Mail/Hand Delivery/Courier (for draft guidance as the guidance was comment on the proposed collection of written/paper submissions): Dockets finalized. Changes from the draft to the certain information by the Agency. Management Staff (HFA–305), Food and final guidance were made to address Under the Paperwork Reduction Act of Drug Administration, 5630 Fishers requests for definitional and process 1995 (PRA), Federal Agencies are Lane, Rm. 1061, Rockville, MD 20852. clarity. required to publish notice in the • For written/paper comments This guidance is being issued Federal Register concerning each submitted to the Dockets Management consistent with FDA’s good guidance proposed collection of information, Staff, FDA will post your comment, as practices regulation (21 CFR 10.115). including each proposed extension of an well as any attachments, except for The guidance represents the current existing collection of information, and information submitted, marked and thinking of FDA on ‘‘Certificates of to allow 60 days for public comment in identified, as confidential, if submitted Confidentiality; Guidance for Sponsors, response to the notice. This notice as detailed in ‘‘Instructions.’’ Sponsor-Investigators, Researchers, solicits comments on information Instructions: All submissions received Industry, and Food and Drug collection associated with applications must include the Docket No. FDA– Administration Staff.’’ It does not for FDA approval to market a new drug. 2020–N–2030 for ‘‘Agency Information establish any rights for any person and DATES: Submit either electronic or Collection Activities; Proposed is not binding on FDA or the public. written comments on the collection of Collection; Comment Request; You can use an alternative approach if information by January 15, 2021. Application for FDA Approval To

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Market a New Drug.’’ Received (OMB) for each collection of use information, supplements and comments, those filed in a timely information they conduct or sponsor. amendments, proposed labeling, and manner (see ADDRESSES), will be placed ‘‘Collection of information’’ is defined specific postmarketing reports. in the docket and, except for those in 44 U.S.C. 3502(3) and 5 CFR Respondents to the information submitted as ‘‘Confidential 1320.3(c) and includes Agency requests collection are sponsors of these Submissions,’’ publicly viewable at or requirements that members of the applications. https://www.regulations.gov or at the public submit reports, keep records, or To assist respondents to the Dockets Management Staff between 9 provide information to a third party. information collection we have a.m. and 4 p.m., Monday through Section 3506(c)(2)(A) of the PRA (44 developed the following forms: Friday, 240–402–7500. U.S.C. 3506(c)(2)(A)) requires Federal • Form FDA 0356h (and instructions): • Confidential Submissions—To Agencies to provide a 60-day notice in Application to Market a New or submit a comment with confidential the Federal Register concerning each Abbreviated New Drug or Biologic for information that you do not wish to be proposed collection of information, Human Use; • made publicly available, submit your including each proposed extension of an Form FDA 2252 (and instructions): comments only as a written/paper existing collection of information, Transmittal of Annual Reports for Drugs submission. You should submit two before submitting the collection to OMB and Biologics For Human Use copies total. One copy will include the (§ 314.81); for approval. To comply with this • information you claim to be confidential requirement, FDA is publishing notice Form FDA 2253 (and instructions): with a heading or cover note that states of the proposed collection of Transmittal of Advertisements and ‘‘THIS DOCUMENT CONTAINS information set forth in this document. Promotional Labeling For Drugs and CONFIDENTIAL INFORMATION.’’ The Biologics For Human Use; and With respect to the following • Agency will review this copy, including collection of information, FDA invites Forms FDA 3331/3331a: Field Alert Report and Instruction; the claimed confidential information, in comments on these topics: (1) Whether • its consideration of comments. The the proposed collection of information Forms FDA 3542 and 3542a and second copy, which will have the is necessary for the proper performance Instructions: Patent Information claimed confidential information of FDA’s functions, including whether Submitted Upon and After Approval of redacted/blacked out, will be available the information will have practical an NDA Supplement; Patent for public viewing and posted on utility; (2) the accuracy of FDA’s Information Submitted With the Filing https://www.regulations.gov. Submit estimate of the burden of the proposed of an NDA, Amendment, or both copies to the Dockets Management collection of information, including the Supplement; • New Draft Form FDA 3898 and Staff. If you do not wish your name and validity of the methodology and contact information to be made publicly Instruction: Drug Master File. assumptions used; (3) ways to enhance Individuals requesting printed forms available, you can provide this the quality, utility, and clarity of the are instructed to contact the FDA Forms information on the cover sheet and not information to be collected; and (4) Manager by email at formsmanager@ in the body of your comments and you ways to minimize the burden of the OC.FDA.GOV. Certain fees may be must identify this information as collection of information on applicable. ‘‘confidential.’’ Any information marked respondents, including through the use Regulations in subpart D (§§ 314.100 as ‘‘confidential’’ will not be disclosed of automated collection techniques, through 314.170) explain Agency except in accordance with 21 CFR 10.20 when appropriate, and other forms of actions on applications and set forth and other applicable disclosure law. For information technology. timeframes for FDA review. We are more information about FDA’s posting revising the information collection to of comments to public dockets, see 80 Application for FDA Approval To Market a New Drug; include provisions established through FR 56469, September 18, 2015, or access our Agency user fee programs, most the information at: https:// OMB Control No. 0910–0001—Revision recently authorized under the FDA www.govinfo.gov/content/pkg/FR-2015- This information collection supports Reauthorization Act of 2017. These 09-18/pdf/2015-23389.pdf. FDA regulations. Under § 505(a) of the provisions pertain to review Docket: For access to the docket to Federal Food, Drug, and Cosmetic Act transparency, communications with read background documents or the (FD&C Act) (21 U.S.C. 355(a)), a new FDA, dispute resolution, drug safety electronic and written/paper comments drug may not be commercially marketed enhancements, and the allocation of received, go to https:// in the United States unless an approval Agency resources to align with these www.regulations.gov and insert the of an application filed with FDA under program objectives as agreed to with our docket number, found in brackets in the § 505(b) or (j) of the FD&C Act is stakeholders and set forth in our heading of this document, into the effective with respect to such drug. We ‘‘Performance Goals for Fiscal Years ‘‘Search’’ box and follow the prompts have issued regulations in part 314 (21 2018–2022’’ Commitment Letters, which and/or go to the Dockets Management CFR part 314) to govern procedures and are available from our website at https:// Staff, 5630 Fishers Lane, Rm. 1061, requirements for applications submitted www.fda.gov along with more Rockville, MD 20852, 240–402–7500. in accordance with section 505. The information about FDA user fee FOR FURTHER INFORMATION CONTACT: regulations in subpart A (§§ 314.1 programs. Domini Bean, Office of Operations, through 314.3) set forth general Information collection pertaining to Food and Drug Administration, Three provisions, while regulations in hearing and other administrative White Flint North, 10A–12M, 11601 subparts B and C (§§ 314.50 through proceedings covered in 21 CFR subpart Landsdown St., North Bethesda, MD 314.99) set forth content and format E are approved under OMB control no. 20852, 301–796–5733, PRAStaff@ requirements for new drug applications 0910–0191. Unless otherwise noted, fda.hhs.gov. (NDAs) and abbreviated new drug information collection pertaining to SUPPLEMENTARY INFORMATION: Under the applications (ANDAs) respectively. The postmarket safety reporting and PRA (44 U.S.C. 3501–3521), Federal regulations include requirements for the associated recordkeeping is approved Agencies must obtain approval from the submission of specific data elements under OMB control nos. 0910–0230, Office of Management and Budget along with patent information, pediatric 0910–0291, and 0910–0645.

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Included among the miscellaneous documents are issued consistent with We use the information collection to provisions in subpart G (§§ 314.410– our good guidance practice regulations approve drugs shown to be safe and 314.445), § 314.420 covers information at § 10.115. To search available FDA effective and to implement effective to include in drug master files (DMFs). guidance documents, visit our website public health monitoring systems. We To assist respondents to this at https://www.fda.gov/regulatory- also use product approval and related information collection we have information/search-fda-guidance- patent and exclusivity information to prepared templates and resources documents. Finally, applications publish the ‘‘Approved Drug Products available from our website at submitted in accordance with subpart H with Therapeutic Equivalence www.fda.gov/drugs/forms-submission- (§§ 314.500 through 314.560) pertain to Evaluations’’ list (the Orange Book). requirements/drug-master-files-dmfs. As accelerated approval of new drugs for More information regarding the Orange noted above, we have developed new serious or life-threatening illness, and book is available from our website at Form FDA 3898 and accompanying instructions on submitting DMFs in submissions in subpart I (§§ 314.600 www.fda.gov/drugs/drug-approvals- accordance with the applicable through 314.650) pertain to approval of and-databases/approved-drug-products- regulations. In accordance with new drugs when human efficacy studies therapeutic-equivalence-evaluations- § 314.445, we also develop Agency are not ethical or feasible. The orange-book. guidance documents to assist regulations provide for the submission We estimate the burden for this respondents in complying with of specific data elements along with collection of information as follows: provisions in part 314. These guidance promotional material.

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

Number of Average burden 21 CFR section Number of responses per Total annual per response Total hours respondents respondent responses (in hours)

SUBPART B

314.50(a)–(l)—Content and format of a 505(b)(1) or 121 1.15 139 1,921...... 267,019 505(b)(2) application. 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 noninfringe- 15 3 45 15...... 675 ment of patent certification. 314.52(c)—Noninfringement of patent certification no- 22 3 66 0.33 (20 minutes) 22 tice content. 314.53(f)(1)—Correction of patent information errors by 24 1 24 10...... 240 persons other than the NDA holder. 314.53(f)(2)—Correction of patent information errors by 28 1.4 39 1...... 39 the NDA holder. 314.60—Amendments to unapproved NDA, supple- 256 8.23 2,106 80...... 168,480 ment or resubmission. 314.60(f)—patent certifications for unapproved applica- 6 1 6 2...... 12 tions. 314.65—Withdrawal of unapproved applications ...... 14 1.21 17 2 ...... 34 314.70 and 314.71—Supplements and other changes 492 6.57 3,232 150...... 484,800 to approved application. 314.72—Changes of ownership of NDAs ...... 67 1.45 97 2 ...... 194 314.81—Other postmarketing reports 314.81(b)(1) 484 20.3 9,834 8...... 78,672 [3331 and 3331a field alert reports and followups]. 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 153 1 153 2...... 306 approval of ANDA. 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 1 1 1 300...... 300 a listed drug other than RLD. 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 1 1 1 300...... 300 equivalent to a listed drug other than RLD. 314.99(a)—ANDA Applicants: Withdrawal of unap- 77 2.3 177 2...... 354 proved ANDAs. 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

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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—Continued

Number of Average burden 21 CFR section Number of responses per Total annual per response Total hours respondents respondent responses (in hours)

314.107(e)—notification of court actions or written con- 247 2 494 0.5 (30 minutes) .. 247 sent to approval.

SUBPART G, H, I

314.420—drug master files [FDA 3938]—original 36 27.2 981 61...... 59,841 amendments. 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 applica- 55 11.6 640 120...... 76,800 tions.

Total ...... 4,118,933.5

Our estimated burden for the DATES: Comments on this ICR should be (CARES Act). The CARES Act information collection reflects a received no later than December 16, appropriated $90 million to HRSA’s decrease. We attribute this adjustment 2020. RWHAP to prevent, prepare for, and to improved operational efficiencies ADDRESSES: Written comments and respond to coronavirus disease 2019 with regard to Agency data systems and recommendations for the proposed (COVID–19). This funding supports 581 digital submission processes. information collection should be sent RWHAP Parts A, B, C, D and F recipients across the country, including Dated: November 10, 2020. within 30 days of publication of this notice to www.reginfo.gov/public/do/ city/county health departments, state Lauren K. Roth, PRAMain. Find this particular health departments, health clinics, Acting Principal Associate Commissioner for information collection by selecting community-based organizations, and Policy. ‘‘Currently under Review—Open for AIDS Education and Training Centers in [FR Doc. 2020–25239 Filed 11–13–20; 8:45 am] Public Comments’’ or by using the their efforts to help prevent or minimize BILLING CODE 4164–01–P search function. the impact of COVID–19 on RWHAP FOR FURTHER INFORMATION CONTACT: To clients. The award provides RWHAP request a copy of the clearance requests recipients the flexibility to meet DEPARTMENT OF HEALTH AND submitted to OMB for review, email Lisa evolving COVID–19 needs in their HUMAN SERVICES Wright-Solomon, the HRSA Information respective communities, including Collection Clearance Officer at extending operational hours, increasing Health Resources and Services [email protected] or call (301) 443– staffing hours, purchasing additional Administration 1984. equipment, enhancing workforce training and capacity development, and Agency Information Collection SUPPLEMENTARY INFORMATION: Information Collection Request Title: providing critical services to people Activities: Submission to OMB for Coronavirus 2019 Data Report OMB No. with HIV during this pandemic, such as Review and Approval; Public Comment 0906–0053—Extension. home-delivered meals, emergency Request; Information Collection Abstract: HRSA’s Ryan White HIV/ housing, and transportation. Request Title: Coronavirus 2019 AIDS Program (RWHAP) funds and HRSA’s HIV/AIDS Bureau identified a (COVID–19) Data Report OMB No. coordinates with cities, states, and local new data collection need to support 0906–0053—Extension clinics/community-based organizations HRSA’s requirement to monitor and to deliver efficient and effective HIV report quarterly to the Secretary of HHS AGENCY: Health Resources and Services care, treatment, and support to low the COVID–19 activities conducted with Administration (HRSA), Department of income people with HIV. Nearly two- the CARES Act funding. The COVID–19 Health and Human Services. thirds of clients (patients) live at or Data Report (CDR) module will collect information on the types of services ACTION: Notice. below 100 percent of the federal poverty level and approximately three-quarters provided and number of people served of RWHAP clients are racial/ethnic for the treatment or prevention of SUMMARY: In compliance with of the minorities. Since 1990, the RWHAP has COVID–19 among RWHAP clients (and Paperwork Reduction Act of 1995, developed a comprehensive system of immediate household members in HRSA has submitted an Information safety net providers who deliver high limited circumstances). This module Collection Request (ICR) to the Office of quality direct health care and support will be required for all providers (e.g., Management and Budget (OMB) for services to over half a million people recipients or subrecipients) who receive review and approval. Comments with HIV—more than 50 percent of all CARES Act RWHAP funding. submitted during the first public review people with diagnosed HIV in the A 60-day notice published in the of this ICR will be provided to OMB. United States. Federal Register on September 1, 2020, OMB will accept further comments from vol. 85, No. 170; pp. 54390–54391. the public during the review and FY 2020 Coronavirus Aid, Relief, and There were no public comments. approval period. OMB may act on Economic Security (CARES) Act Need and Proposed Use of the HRSA’s ICR only after the 30 day On March 27, 2020, the President Information: HRSA proposes that comment period for this notice has signed into law the ‘‘Coronavirus Aid, service providers who receive CARES closed. Relief, and Economic Security Act’’ Act RWHAP funding report aggregate

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