22132 Federal Register / Vol. 84, No. 95 / Thursday, May 16, 2019 / Notices

www.regulations.gov and insert the II. Drug Products For Which New Draft to https://www.regulations.gov and docket number, found in brackets in the Product-Specific Guidances Are enter Docket No. FDA–2007–D–0369. heading of this document, into the Available These draft guidances are being ‘‘Search’’ box and follow the prompts issued consistent with FDA’s good and/or go to the Dockets Management FDA is announcing the availability of guidance practices regulation (21 CFR Staff, 5630 Fishers Lane, Rm. 1061, new draft product-specific guidances for 10.115). These draft guidances, when Rockville, MD 20852. industry for drug products containing finalized, will represent the current the following active ingredients: You may submit comments on any thinking of FDA on, among other things, the product-specific design of BE guidance at any time (see 21 CFR TABLE 1—NEW DRAFT PRODUCT-SPE- 10.115(g)(5)). studies to support ANDAs. They do not CIFIC GUIDANCES FOR DRUG PROD- establish any rights for any person and Submit written requests for single UCTS are not binding on FDA or the public. copies of the draft guidances to the You can use an alternative approach if Division of Drug Information, Center for Acetaminophen; Codeine phosphate it satisfies the requirements of the Drug Evaluation and Research, Food Apalutamide applicable statutes and regulations. and Drug Administration, 10001 New Beclomethasone dipropionate These guidances are not subject to Benoxinate hydrochloride; Fluorescein so- Hampshire Ave., Hillandale Building, Executive Order 12866. 4th Floor, Silver Spring, MD 20993– dium 0002. Send one self-addressed adhesive Bictegravir sodium; Emtricitabine; Tenofovir IV. Electronic Access label to assist that office in processing alafenamide fumarate Brimonidine tartrate Persons with access to the internet your requests. See the SUPPLEMENTARY Budesonide may obtain the draft guidances at either INFORMATION section for electronic Chlorpheniramine maleate; Ibuprofen; https://www.fda.gov/Drugs/Guidance access to the draft guidance documents. Pseudoephedrine hydrochloride ComplianceRegulatoryInformation/ Cyclosporine FOR FURTHER INFORMATION CONTACT: Guidances/default.htm or https:// Desloratadine; Pseudoephedrine sulfate www.regulations.gov. Wendy Good, Center for Drug Desmopressin acetate Evaluation and Research, Food and Efavirenz; Lamivudine; Tenofovir disoproxil Dated: May 13, 2019. Drug Administration, 10903 New fumarate (multiple Reference Listed Drugs) Lowell J. Schiller, Hampshire Ave., Bldg. 75, Rm. 4714, Eravacycline dihydrochloride Principal Associate Commissioner for Policy. Estradiol; levonorgestrel Silver Spring, MD 20993–0002, 240– [FR Doc. 2019–10165 Filed 5–15–19; 8:45 am] 402–1146. Fluticasone furoate Fluticasone propionate BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION: Fluticasone propionate; Salmeterol xinafoate Fosnetupitant chloride hydrochloride; I. Background Palonosetron hydrochloride DEPARTMENT OF HEALTH AND HUMAN SERVICES In the Federal Register of June 11, Halcinonide Lamivudine; Tenofovir disoproxil fumarate 2010 (75 FR 33311), FDA announced the Naproxen [Document Identifier: OS–0990–0458 availability of a guidance for industry Omeprazole magnesium Revision] entitled ‘‘Bioequivalence Primidone Recommendations for Specific Timolol maleate Agency Information Collection Products’’ that explained the process Tobramycin Request; 30-Day Public Comment that would be used to make product- Request specific guidances available to the III. Drug Products for Which Revised AGENCY: Office of the Secretary, HHS. public on FDA’s website at https:// Draft Product-Specific Guidances are ACTION: Notice. www.fda.gov/Drugs/Guidance Available ComplianceRegulatoryInformation/ SUMMARY: In compliance with section Guidances/default.htm. FDA is announcing the availability of revised draft product-specific guidances 3506(c)(2)(A) of the Paperwork As described in that guidance, FDA for industry for drug products Reduction Act of 1995, the Office of the adopted this process as a means to containing the following active Secretary (OS), Department of Health develop and disseminate product- ingredients: and Human Services, is publishing the specific guidances and provide a following summary of a proposed meaningful opportunity for the public to TABLE 2—REVISED DRAFT PRODUCT- revision of a collection for public consider and comment on those comment. SPECIFIC GUIDANCES FOR DRUG guidances. Under that process, draft PRODUCTS DATES: Comments on the ICR must be guidances are posted on FDA’s website received on or before June 17, 2019. and announced periodically in the Federal Register. The public is Azelaic acid (multiple Reference Listed ADDRESSES: Submit your comments to Drugs) _ encouraged to submit comments on OIRA [email protected] or via Betaxolol hydrochloride facsimile to (202) 395–5806. those recommendations within 60 days Brimonidine tartrate; Brinzolamide FOR FURTHER INFORMATION CONTACT of their announcement in the Federal Brinzolamide : Register. FDA considers any comments Fosfomycin tromethamine Sherrette Funn, [email protected] received and either publishes final Ivermectin or (202) 795–7714. When submitting guidances or publishes revised draft Methylprednisolone comments or requesting information, guidances for comment. Guidances were Prednisolone acetate please include the document identifier last announced in the Federal Register Tofacitinib citrate OS–0990–0458 Revision, and project on February 25, 2019 (84 FR 6005). This title for reference. notice announces draft product-specific For a complete history of previously SUPPLEMENTARY INFORMATION: Interested guidances, either new or revised, that published Federal Register notices persons are invited to send comments are posted on FDA’s website. related to product-specific guidances, go regarding this burden estimate or any

VerDate Sep<11>2014 17:22 May 15, 2019 Jkt 247001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\16MYN1.SGM 16MYN1 khammond on DSKBBV9HB2PROD with NOTICES Federal Register / Vol. 84, No. 95 / Thursday, May 16, 2019 / Notices 22133

other aspect of this collection of a revision to add a 24-month follow-up enrollment (Time 1), and at follow-up information, including any of the data collection to an existing interviews every six months after the following subjects: (1) The necessity and information collection request entitled, Time 1 Interview (i.e., 6, 12, and 18 utility of the proposed information ‘‘Domestic Violence Housing First months) to examine the match between collection for the proper performance of (DVHF) Demonstration Evaluation’’ needs and services, as well as their the agency’s functions; (2) the accuracy (OMB Control Number: HHS–OS–0990– safety and housing stability. The of the estimated burden; (3) ways to 0458). The Washington State Coalition proposed revision to the collection enhance the quality, utility, and clarity against Domestic Violence (WSCADV) is would add a fourth follow-up data of the information to be collected; and overseeing and coordinating an collection to be administered 24 months (4) the use of automated collection evaluation of the DVHF Demonstration after study enrollment (Time 1) to techniques or other forms of information project through a contract with ASPE. examine longer-term impacts of the technology to minimize the information This quasi-experimental research study Domestic Violence Housing First collection burden. involves longitudinally examining the Demonstration program. The follow-up Title of the Collection: Domestic program effects of DVHF on domestic survey is identical to the one used at the Violence Housing First Demonstration violence survivors’ safety and housing 6, 12, and 18 month follow-up. The Evaluation. stability. The findings will be of interest respondents are domestic violence Type of Collection: Revision. to the general public, to policy-makers, survivors who are enrolled in the OMB No.: 0990–0458. and to organizations working with Domestic Violence Housing First Abstract: The Office of the Assistant domestic violence survivors. Demonstration Evaluation (OMB Secretary for Planning and Evaluation Current data collection that has been Control Number HHS–OS–0990–0458). (ASPE) within the U.S. Department of approved by OMB includes in-depth, Study enrollment is taking place over 15 Health and Human Services, in private interviews with 320 domestic months, so the annualized burden for partnership with the Office for Victims violence survivors conducted by trained the 24-month follow-up survey is based of Crimes within the U.S. Department of professional staff. The data are currently on 12/15 (256) of the expected sample Justice, is seeking approval by OMB for approved for collection at study (320).

ANNUALIZED BURDEN HOUR TABLE

Annual Number of Average Form name Type of number of responses per burden hours Total annual respondent respondents respondent per response burden hours

Follow-up Interview ...... Domestic violence survivors ...... 256 1 1.25 320

Total ...... 320

Dated: May 8, 2019. agreements for American Indians into programs and recruit individuals to Terry Clark, Psychology. This program is authorized become Clinical Psychologists who will Office of the Secretary, Asst. Paperwork under section 217 of the Indian Health provide services to AI/AN people. Reduction Act Reports Clearance Officer. Care Improvement Act, Public Law 94– Psychology program scholarship grants [FR Doc. 2019–10107 Filed 5–15–19; 8:45 am] 437, as amended (IHCIA), codified at 25 may be used by the educational BILLING CODE 4150–05–P U.S.C. 1621p. This program is described institution to provide scholarships to in the Assistance Listings located at Indian students enrolled in clinical https://beta.sam.gov (formerly known as psychology education programs. DEPARTMENT OF HEALTH AND Catalog of Federal Domestic Assistance) According to the terms and conditions HUMAN SERVICES under 93.970. of the psychology program scholarship grant award, scholarship awards are for Background Indian Health Service a l-year period; additional scholarship The IHS, an agency within the support may be awarded to each eligible American Indians Into Psychology Department of Health and Human student for up to four years (maximum). Announcement Type: New and Services (HHS), is responsible for Purpose Competing Continuation. providing Federal health services to Funding Announcement Number: American Indians and Alaska Natives The purpose of this IHS cooperative HHS–2019–IHS–INPSY–0001. (AI/AN). The mission of the IHS is to agreement is to augment the number of Assistance Listing (Catalog of Federal raise the physical, mental, social, and Indian Clinical Psychologists who Domestic Assistance) Number: 93.970. spiritual health of AI/AN. The IHCIA deliver health care services to AI/AN communities. The primary objectives of Key Dates authorizes the IHS to administer programs that are designed to attract this cooperative agreement award are to: Application Deadline Date: June 20, and recruit qualified individuals into (1) Recruit and train individuals to be 2019. health professions to ensure the Clinical Psychologists; and (2) provide Earliest Anticipated Start Date: July availability of health professionals to scholarships to individuals enrolled in 20, 2019. serve AI/AN populations. Section 217 of schools of clinical psychology to pay tuition, books, fees and stipends for I. Funding Opportunity Description the IHCIA authorizes IHS to administer the American Indians into Psychology living expenses. Statutory Authority Program. Within the Section 217 II. Award Information The Indian Health Service (IHS) program, IHS provides grants to colleges Division of Health Professions Support, and universities to develop and Funding Instrument is accepting applications for cooperative maintain psychology education Cooperative Agreement.

VerDate Sep<11>2014 17:22 May 15, 2019 Jkt 247001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\16MYN1.SGM 16MYN1 khammond on DSKBBV9HB2PROD with NOTICES