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Draft Guidances Instructions: All Submissions Received Technology Federal Register / Vol. 85, No. 224 / Thursday, November 19, 2020 / Notices 73725 ANNUAL BURDEN ESTIMATES Total number of Average burden Instrument Total number of responses per hours per Total burden Annual burden respondents respondent response hours hours CSBG Annual Report (States) ................................... 52 3 198 30,088 10,029 CSBG Annual Report (Eligible Entities) .................... 1,009 3 697 2,109,819 703,273 CSBG CARES Supplemental Annual Report (States) ................................................................... 52 3 107 16,692 5,564 CSBG CARES Annual Report (Eligible Entities) ....... 1,009 3 493 1,492,311 497,437 CSBG Disaster Supplemental Annual Report (States) ................................................................... 15 3 95 4,275 1,425 CSBG Disaster Supplemental Annual Report (Eligi- ble Entities) ............................................................. 50 3 476 71,400 23,800 Estimated Total Annual Burden drug applications (ANDAs). In the manner detailed (see ‘‘Written/Paper Hours: 1,241,528. Federal Register of June 11, 2010, FDA Submissions’’ and ‘‘Instructions’’). Comments: The Department announced the availability of a guidance Written/Paper Submissions specifically requests comments on (a) for industry entitled ‘‘Bioequivalence whether the proposed collection of Recommendations for Specific Submit written/paper submissions as information is necessary for the proper Products’’ that explained the process follows: • performance of the functions of the that would be used to make product- Mail/Hand Delivery/Courier (for agency, including whether the specific guidances available to the written/paper submissions): Dockets information shall have practical utility; public on FDA’s website. The guidances Management Staff (HFA–305), Food and (b) the accuracy of the agency’s estimate identified in this notice were developed Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. of the burden of the proposed collection using the process described in that • of information; (c) the quality, utility, guidance. For written/paper comments and clarity of the information to be submitted to the Dockets Management collected; and (d) ways to minimize the DATES: Submit either electronic or Staff, FDA will post your comment, as burden of the collection of information written comments on the draft well as any attachments, except for information submitted, marked and on respondents, including through the guidances by January 19, 2021 to ensure identified, as confidential, if submitted use of automated collection techniques that the Agency considers your as detailed in ‘‘Instructions.’’ or other forms of information comment on these draft guidances Instructions: All submissions received technology. Consideration will be given before it begins work on the final must include the Docket No. FDA– to comments and suggestions submitted versions of the guidances. 2007–D–0369 for ‘‘Product-Specific within 60 days of this publication. ADDRESSES: You may submit comments Guidances; Draft and Revised Draft on any guidance at any time as follows: Authority: 112 Stat. 2729; 42 U.S.C. Guidances for Industry.’’ Received 9902(2). Electronic Submissions comments will be placed in the docket and, except for those submitted as Mary B. Jones, Submit electronic comments in the ACF/OPRE Certifying Officer. ‘‘Confidential Submissions,’’ publicly following way: viewable at https://www.regulations.gov [FR Doc. 2020–25479 Filed 11–18–20; 8:45 am] • Federal eRulemaking Portal: or at the Dockets Management Staff BILLING CODE 4184–27–P https://www.regulations.gov. Follow the between 9 a.m. and 4 p.m., Monday instructions for submitting comments. through Friday, 240–402–7500. Comments submitted electronically, • Confidential Submissions—To DEPARTMENT OF HEALTH AND including attachments, to https:// HUMAN SERVICES submit a comment with confidential www.regulations.gov will be posted to information that you do not wish to be Food and Drug Administration the docket unchanged. Because your made publicly available, submit your comment will be made public, you are comments only as a written/paper [Docket No. FDA–2007–D–0369] solely responsible for ensuring that your submission. You should submit two comment does not include any Product-Specific Guidances; Draft and copies total. One copy will include the confidential information that you or a information you claim to be confidential Revised Draft Guidances for Industry; third party may not wish to be posted, Availability with a heading or cover note that states such as medical information, your or ‘‘THIS DOCUMENT CONTAINS AGENCY: Food and Drug Administration, anyone else’s Social Security number, or CONFIDENTIAL INFORMATION.’’ The HHS. confidential business information, such Agency will review this copy, including as a manufacturing process. Please note ACTION: Notice of availability. the claimed confidential information, in that if you include your name, contact its consideration of comments. The SUMMARY: The Food and Drug information, or other information that second copy, which will have the Administration (FDA or Agency) is identifies you in the body of your claimed confidential information announcing the availability of comments, that information will be redacted/blacked out, will be available additional draft and revised draft posted on https://www.regulations.gov. for public viewing and posted on product-specific guidances. The • If you want to submit a comment https://www.regulations.gov. Submit guidances provide product-specific with confidential information that you both copies to the Dockets Management recommendations on, among other do not wish to be made available to the Staff. If you do not wish your name and things, the design of bioequivalence public, submit the comment as a contact information to be made publicly (BE) studies to support abbreviated new written/paper submission and in the available, you can provide this VerDate Sep<11>2014 19:40 Nov 18, 2020 Jkt 253001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\19NON1.SGM 19NON1 73726 Federal Register / Vol. 85, No. 224 / Thursday, November 19, 2020 / Notices information on the cover sheet and not guidances are posted on FDA’s website TABLE 2—REVISED DRAFT PRODUCT- in the body of your comments and you and announced periodically in the SPECIFIC GUIDANCES FOR DRUG must identify this information as Federal Register. The public is PRODUCTS—Continued ‘‘confidential.’’ Any information marked encouraged to submit comments on as ‘‘confidential’’ will not be disclosed those recommendations within 60 days Active ingredient(s) except in accordance with 21 CFR 10.20 of their announcement in the Federal and other applicable disclosure law. For Register. FDA considers any comments Fluphenazine hydrochloride more information about FDA’s posting received and either publishes final Hydrocortisone acetate of comments to public dockets, see 80 guidances or publishes revised draft Isotretinoin (multiple referenced listed drugs) Levorphanol tartrate FR 56469, September 18, 2015, or access guidances for comment. Guidances were Lomitapide mesylate the information at: https:// last announced in the Federal Register Methylphenidate hydrochloride www.govinfo.gov/content/pkg/FR-2015- on August 26, 2020. This notice Pimavanserin tartrate 09-18/pdf/2015-23389.pdf. announces draft product-specific Propranolol hydrochloride (multiple ref- Docket: For access to the docket to guidances, either new or revised, that erenced listed drugs) read background documents or the are posted on FDA’s website. Tofacitinib citrate electronic and written/paper comments II. Drug Products For Which New Draft received, go to https:// For a complete history of previously Product-Specific Guidances Are www.regulations.gov and insert the published Federal Register notices Available docket number, found in brackets in the related to product-specific guidances, go heading of this document, into the FDA is announcing the availability of to https://www.regulations.gov and ‘‘Search’’ box and follow the prompts new draft product-specific guidances for enter Docket No. FDA–2007–D–0369. and/or go to the Dockets Management industry for drug products containing These draft guidances are being Staff, 5630 Fishers Lane, Rm. 1061, the following active ingredients: issued consistent with FDA’s good Rockville, MD 20852, 240–402–7500. guidance practices regulation (21 CFR You may submit comments on any TABLE 1—NEW DRAFT PRODUCT-SPE- 10.115). These draft guidances, when guidance at any time (see 21 CFR CIFIC GUIDANCES FOR DRUG PROD- finalized, will represent the current 10.115(g)(5)). UCTS thinking of FDA on, among other things, Submit written requests for single the product-specific design of BE copies of the draft guidances to the Active ingredient(s) studies to support ANDAs. They do not Division of Drug Information, Center for establish any rights for any person and Drug Evaluation and Research, Food Ceritinib are not binding on FDA or the public. Clobazam and Drug Administration, 10001 New You can use an alternative approach if Crofelemer it satisfies the requirements of the Hampshire Ave., Hillandale Building, Diazepam 4th Floor, Silver Spring, MD 20993– Epinephrine applicable statutes and regulations. 0002. Send one self-addressed adhesive Fluorodopa F–18 IV. Paperwork Reduction Act of 1995 label to assist that office in processing Lefamulin acetate FDA tentatively concludes that this your requests. See the SUPPLEMENTARY Naloxone hydrochloride; Oxycodone
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