Federal Register/Vol. 85, No. 221/Monday
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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 VerDate Sep<11>2014 20:13 Nov 13, 2020 Jkt 253001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\16NON1.SGM 16NON1 jbell on DSKJLSW7X2PROD with NOTICES 73058 Federal Register / Vol. 85, No. 221 / Monday, November 16, 2020 / Notices 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