Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices 64533

TABLE 1—NEW DRAFT PRODUCT-SPE- TABLE 2—REVISED DRAFT PRODUCT- Dated: November 18, 2019. CIFIC GUIDANCES FOR DRUG PROD- SPECIFIC GUIDANCES FOR DRUG Lowell J. Schiller, UCTS PRODUCTS—Continued Principal Associate Commissioner for Policy. [FR Doc. 2019–25326 Filed 11–21–19; 8:45 am] Active ingredient(s) Active ingredient(s) BILLING CODE 4164–01–P

Acetaminophen; Benzhydrocodone hydro- Disopyramide phosphate. chloride. Doxepin hydrochloride. DEPARTMENT OF HEALTH AND Betamethasone dipropionate; Calcipotriene. Estradiol (multiple reference listed drugs). HUMAN SERVICES Cefaclor. Estradiol; Levonorgestrel. Chlorzoxazone (multiple reference listed Estradiol; Norethindrone acetate. Food and Drug Administration drugs). Ethinyl estradiol; Norelgestromin. Copper. Fentanyl. [Docket No. FDA–2016–N–0736] Dolutegravir sodium; Rilpivirine hydro- Flavoxate hydrochloride. chloride. Granisetron. Agency Information Collection Doxycycline hyclate. Indapamide. Activities; Proposed Collection; Encorafenib. Lidocaine. Comment Request; Tracking Network Fluorometholone acetate. Lithium carbonate. for PETNet, LivestockNet, and Indocyanine green. Menthol; Methyl salicylate. SampleNet Isoniazid; Pyrazinamide; Rifampin. Metformin hydrochloride; Repaglinide. Isosorbide dinitrate. Methylphenidate. AGENCY: Food and Drug Administration, Ketoprofen. Mifepristone. HHS. Latanoprost; Netarsudil dimesylate. Molindone hydrochloride. Lidocaine. Mycophenolate mofetil. ACTION: Notice. Lorlatinib. Nicotine. Lovastatin. Nitrofurantoin, Macrocrystalline. SUMMARY: The Food and Drug Lutetium dotatate Lu-177. Nitrofurantoin; Nitrofurantoin, Administration (FDA, the Agency, or Medroxyprogesterone acetate. Macrocrystalline. we) is announcing an opportunity for Meloxicam. Nitroglycerin (multiple reference listed drugs). public comment on the proposed Mifepristone. Oxybutynin (multiple reference listed drugs). collection of certain information by the Migalastat hydrochloride. Pimecrolimus. Agency. Under the Paperwork Omadacycline tosylate (multiple reference Prednisolone sodium phosphate. Reduction Act of 1995 (PRA), Federal listed drugs). Rivastigmine. Agencies are required to publish notice Oxymetazoline hydrochloride. Roflumilast. Pimavanserin tartrate. Rotigotine. in the Federal Register concerning each Sumatriptan succinate. Scopolamine. proposed collection of information, Tetracaine hydrochloride. Selegiline. including each proposed extension of an Timolol maleate. Sulfacetamide sodium. existing collection of information, and Sulfadiazine. to allow 60 days for public comment in III. Drug Products for Which Revised Tazarotene (multiple reference listed drugs). response to the notice. This notice Draft Product-Specific Guidances are Terazosin hydrochloride. solicits comments on our use of a Available Testosterone. tracking network to collect and share Tinidazole. safety information about animal food FDA is announcing the availability of Tipiracil hydrochloride; Trifluridine. revised draft product-specific guidances Tretinoin (multiple reference listed drugs). from Federal, State, and Territorial for industry for drug products Agencies. containing the following active For a complete history of previously DATES: Submit either electronic or ingredients: published Federal Register notices written comments on the collection of related to product-specific guidances, go information by January 21, 2020. TABLE 2—REVISED DRAFT PRODUCT- to https://www.regulations.gov and ADDRESSES: You may submit comments SPECIFIC GUIDANCES FOR DRUG enter Docket No. FDA–2007–D–0369. as follows. Please note that late, PRODUCTS These draft guidances are being untimely filed comments will not be issued consistent with FDA’s good considered. Electronic comments must Active ingredient(s) guidance practices regulation (21 CFR be submitted on or before January 21, 10.115). These draft guidances, when 2020. The https://www.regulations.gov Adapalene (multiple reference listed drugs). finalized, will represent the current electronic filing system will accept Adapalene; Benzoyl peroxide (multiple ref- thinking of FDA on, among other things, erence listed drugs). comments until 11:59 p.m. Eastern Time Azacitidine. the product-specific design of BE at the end of January 21, 2020. Baclofen. studies to support ANDAs. They do not Comments received by mail/hand Benzoyl peroxide; Clindamycin phosphate establish any rights for any person and delivery/courier (for written/paper (multiple reference listed drugs). are not binding on FDA or the public. submissions) will be considered timely Benzoyl peroxide; Erythromycin (multiple ref- You can use an alternative approach if if they are postmarked or the delivery erence listed drugs). it satisfies the requirements of the service acceptance receipt is on or Capsaicin. applicable statutes and regulations. before that date. Cariprazine hydrochloride. Clindamycin phosphate (multiple reference IV. Electronic Access Electronic Submissions listed drugs). Persons with access to the internet Clindamycin phosphate; Tretinoin. Submit electronic comments in the Clonidine. may obtain the draft guidances at either following way: Clonidine hydrochloride. https://www.fda.gov/Drugs/Guidance • Federal eRulemaking Portal: Dapsone (multiple reference listed drugs). ComplianceRegulatoryInformation/ https://www.regulations.gov. Follow the Diclofenac epolamine. Guidances/default.htm or https:// instructions for submitting comments. Didanosine. www.regulations.gov. Comments submitted electronically,

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including attachments, to https:// second copy, which will have the is necessary for the proper performance www.regulations.gov will be posted to claimed confidential information of FDA’s functions, including whether the docket unchanged. Because your redacted/blacked out, will be available the information will have practical comment will be made public, you are for public viewing and posted on utility; (2) the accuracy of FDA’s solely responsible for ensuring that your https://www.regulations.gov. Submit estimate of the burden of the proposed comment does not include any both copies to the Dockets Management collection of information, including the confidential information that you or a Staff. If you do not wish your name and validity of the methodology and third party may not wish to be posted, contact information to be made publicly assumptions used; (3) ways to enhance such as medical information, your or available, you can provide this the quality, utility, and clarity of the anyone else’s Social Security number, or information on the cover sheet and not information to be collected; and (4) confidential business information, such in the body of your comments and you ways to minimize the burden of the as a manufacturing process. Please note must identify this information as collection of information on that if you include your name, contact ‘‘confidential.’’ Any information marked respondents, including through the use information, or other information that as ‘‘confidential’’ will not be disclosed of automated collection techniques, identifies you in the body of your except in accordance with 21 CFR 10.20 when appropriate, and other forms of comments, that information will be and other applicable disclosure law. For information technology. posted on https://www.regulations.gov. more information about FDA’s posting • If you want to submit a comment of comments to public dockets, see 80 Tracking Network for PETNet, with confidential information that you FR 56469, September 18, 2015, or access LivestockNet, and SampleNet do not wish to be made available to the the information at: https://www.gpo.gov/ OMB Control Number 0910–0680— public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015- Extension written/paper submission and in the 23389.pdf. manner detailed (see ‘‘Written/Paper Docket: For access to the docket to The Center for Veterinary Medicine Submissions’’ and ‘‘Instructions’’). read background documents or the and the Partnership for Food Protection Written/Paper Submissions electronic and written/paper comments developed a web-based tracking received, go to https:// network (the tracking network) to allow Submit written/paper submissions as www.regulations.gov and insert the Federal, State, and Territorial regulatory follows: docket number, found in brackets in the and public health Agencies to share • Mail/Hand Delivery/Courier (for heading of this document, into the safety information about animal food. written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts Information is submitted to the tracking Management Staff (HFA–305), Food and and/or go to the Dockets Management network by regulatory and public health Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, Agency employees with membership Lane, Rm. 1061, Rockville, MD 20852. rights. The efficient exchange of safety • For written/paper comments Rockville, MD 20852. information is necessary because it submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT: improves early identification and Staff, FDA will post your comment, as Jonnalynn Capezzuto, Office of evaluation of a risk associated with an well as any attachments, except for Operations, Food and Drug animal food product. We use the information submitted, marked and Administration, Three White Flint information to assist regulatory identified, as confidential, if submitted North, 10A–12M, 11601 Landsdown St., Agencies to quickly identify and as detailed in ‘‘Instructions.’’ North Bethesda, MD 20852, 301–796– Instructions: All submissions received 3794, [email protected]. evaluate a risk and take whatever action must include the Docket No. FDA– SUPPLEMENTARY INFORMATION: Under the is necessary to mitigate or eliminate 2016–N–0736 for ‘‘Agency Information PRA (44 U.S.C. 3501–3521), Federal exposure to the risk. Earlier Collection Activities; Proposed Agencies must obtain approval from the identification and communication with Collection; Comment Request; Tracking Office of Management and Budget respect to emerging safety information Network for PETNet, LivestockNet, and (OMB) for each collection of may also mitigate the potential adverse SampleNet.’’ Received comments, those information they conduct or sponsor. economic impact for the impacted filed in a timely manner (see ‘‘Collection of information’’ is defined parties associated with such safety ADDRESSES), will be placed in the docket in 44 U.S.C. 3502(3) and 5 CFR issues. The tracking network was and, except for those submitted as 1320.3(c) and includes Agency requests developed under the requirements set ‘‘Confidential Submissions,’’ publicly or requirements that members of the forth under section 1002(b) of the Food viewable at https://www.regulations.gov public submit reports, keep records, or and Drug Administration Amendments or at the Dockets Management Staff provide information to a third party. Act of 2007 (FDAAA) (Pub. L. 110–085). between 9 a.m. and 4 p.m., Monday Section 3506(c)(2)(A) of the PRA (44 Section 1002(b) of the FDAAA required through Friday. U.S.C. 3506(c)(2)(A)) requires Federal FDA, in relevant part, to establish a pet • Confidential Submissions—To Agencies to provide a 60-day notice in food early warning alert system. submit a comment with confidential the Federal Register concerning each The tracking network collects: (1) information that you do not wish to be proposed collection of information, Reports of pet food-related illness and made publicly available, submit your including each proposed extension of an product defects associated with dog comments only as a written/paper existing collection of information, food, cat food, and food for other pets, submission. You should submit two before submitting the collection to OMB which are submitted via the Pet Event copies total. One copy will include the for approval. To comply with this Tracking Network (PETNet); (2) reports information you claim to be confidential requirement, FDA is publishing notice of animal food-related illness and with a heading or cover note that states of the proposed collection of product defects associated with animal ‘‘THIS DOCUMENT CONTAINS information set forth in this document. food for livestock animals, aquaculture CONFIDENTIAL INFORMATION.’’ The With respect to the following species, and horses (LivestockNet); and Agency will review this copy, including collection of information, FDA invites (3) reports about animal food laboratory the claimed confidential information, in comments on these topics: (1) Whether samples considered adulterated by State its consideration of comments. The the proposed collection of information or FDA regulators (SampleNet).

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PETNet and LivestockNet reports member logs in to the system). For the number, the reason for testing, whether share the following common data LivestockNet report, additional data the food was reported to the Reportable elements, the majority of which are drop elements specific to livestock animals Food Registry, who performed the down menu choices: product details are captured: Product details (indication analysis); and results information (product name, lot code, product form, of whether the product is a medicated (analyte, test method, analytical results, and the manufacturer or distributor/ product, product packaging, and whether the results contradict a label packer (if known)), the species affected, intended purpose of the product), class claim or guarantee, and whether action number of animals exposed to the of the animal species affected, and was taken as a result of the sample product, number of animals affected, production loss. For PETNet reports, the analysis). body systems affected, product only additional data field is the animal Description of Respondents: problem/defect, date of onset or the date life stage. The SampleNet reports have product problem was detected, the State the following data elements, many of Voluntary respondents to this collection where the incident occurred, the origin which are drop down menu choices: of information are Federal, State, and of the information, whether there are Product information (product name, lot Territorial regulatory and public health supporting laboratory results, and code, guarantor information, date and Agency employees with membership contact information for the reporting location of sample collection, and access to the Animal Feed Network. member (i.e., name, telephone number product description); laboratory FDA estimates the burden of this will be captured automatically when information (sample identification collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of Number of Total annual Average burden Activity responses per Total hours respondents respondent responses per response

PETNet ...... 20 5 100 0.25 (15 minutes) ...... 25 LivestockNET ...... 20 5 100 0.25 (15 minutes) ...... 25 SampleNet ...... 20 5 100 0.25 (15 minutes) ...... 25

Total ...... 75 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on a review of the information DATES: Fax written comments on the (FD&C Act) (21 U.S.C. 393(d)(2)), the collection since our last request for collection of information by December Commissioner of Food and Drugs is OMB approval, we have made no 23, 2019. authorized to implement general powers adjustments to our burden estimate. ADDRESSES: To ensure that comments on (including conducting research) to carry the information collection are received, out effectively the mission of FDA. Dated: November 14, 2019. After the events of September 11, Lowell J. Schiller, OMB recommends that written comments be faxed to the Office of 2001, and as part of broader Principal Associate Commissioner for Policy. Information and Regulatory Affairs, counterterrorism and emergency [FR Doc. 2019–25327 Filed 11–21–19; 8:45 am] OMB, Attn: FDA Desk Officer, Fax: 202– preparedness activities, FDA’s Center BILLING CODE 4164–01–P 395–7285, or emailed to oira_ for Devices and Radiological Health [email protected]. All (CDRH) began developing operational comments should be identified with the plans and interventions that would DEPARTMENT OF HEALTH AND OMB control number 0910–0491. Also enable CDRH to anticipate and respond HUMAN SERVICES include the FDA docket number found to medical device shortages that might arise in the context of federally declared in brackets in the heading of this disasters/emergencies or regulatory Food and Drug Administration document. actions. In particular, CDRH identified [Docket No. FDA–2012–N–0197] FOR FURTHER INFORMATION CONTACT: the need to acquire and maintain JonnaLynn Capezzuto, Office of detailed data on domestic inventory, Agency Information Collection Operations, Food and Drug manufacturing capabilities, distribution Activities; Submission for Office of Administration, Three White Flint plans, and raw material constraints for Management and Budget Review; North, 10A–12M, 11601 Landsdown St., medical devices that would be in high Comment Request; Medical Devices; North Bethesda, MD 20852, 301–796– demand and/or would be vulnerable to Shortages Data Collection System 3794, [email protected]. shortages in specific disaster/emergency SUPPLEMENTARY INFORMATION: In situations or following specific AGENCY: Food and Drug Administration, compliance with 44 U.S.C. 3507, FDA regulatory actions. Such data could HHS. has submitted the following proposed support prospective risk assessment, collection of information to OMB for help inform risk mitigation strategies, ACTION: Notice. review and clearance. support real-time decision making by the Department of Health and Human SUMMARY: The Food and Drug Medical Devices; Shortages Data Services during actual emergencies or Administration (FDA) is announcing Collection System emergency preparedness exercises, and that a proposed collection of mitigate or prevent harm to the public OMB Control Number 0910–0491— information has been submitted to the health. Office of Management and Budget Reinstatement The data collection process will (OMB) for review and clearance under Under section 1003(d)(2) of the consist of an initial telephone call to the Paperwork Reduction Act of 1995. Federal Food, Drug, and Cosmetic Act firms who have been identified as

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