34454 Federal Register / Vol. 85, No. 108 / Thursday, June 4, 2020 / Notices

Register. FDA considers any comments TABLE 2—REVISED DRAFT PRODUCT- DEPARTMENT OF HEALTH AND received and either publishes final SPECIFIC GUIDANCES FOR DRUG HUMAN SERVICES guidances or publishes revised draft PRODUCTS—Continued guidances for comment. Guidances were Health Resources and Services last announced in the Federal Register Active ingredient(s) Administration on March 3, 2020. This notice announces draft product-specific Clindamycin phosphate (multiple referenced Agency Information Collection guidances, either new or revised, that listed drugs). Activities: Proposed Collection: Public are posted on FDA’s website. Clindamycin phosphate; Tretinoin (multiple Comment Request; Information referenced listed drugs). Collection Request Title: Substance II. Drug Products for Which New Draft Dapagliflozin. Use Disorder Treatment and Recovery Product-Specific Guidances Are Dapagliflozin; Saxagliptin hydrochloride. Loan Repayment Program, OMB No. Available Desvenlafaxine. 0906—xxxx—New FDA is announcing the availability of Desvenlafaxine fumarate. AGENCY: Health Resources and Services new draft product-specific guidances for Desvenlafaxine succinate. Administration (HRSA), Department of industry for drug products containing Dihydroergotamine mesylate. Health and Human Services (HHS). the following active ingredients: Diltiazem hydrochloride (multiple referenced listed drugs). ACTION: Notice. TABLE 1—NEW DRAFT PRODUCT-SPE- Everolimus. SUMMARY: In compliance with the CIFIC GUIDANCES FOR DRUG PROD- Ferric citrate. Fluticasone furoate. requirement for opportunity for public UCTS Fluticasone propionate. comment on proposed data collection projects of the Paperwork Reduction Act Active ingredient(s) Fluticasone propionate; Salmeterol xinafoate. Methylphenidate hydrochloride (multiple ref- of 1995, HRSA announces plans to Abiraterone acetate. erenced listed drugs). submit an Information Collection Amoxicillin. Metoprolol tartrate. Request (ICR), described below, to the Aprepitant. Metronidazole. Office of Management and Budget Brexanolone. Mometasone furoate. (OMB). Prior to submitting the ICR to Buprenorphine. Tretinoin (multiple referenced listed drugs). OMB, HRSA seeks comments from the Desvenlafaxine. Triamcinolone acetonide. public regarding the burden estimate, Dolutegravir sodium; Lamivudine. Efavirenz; Lamivudine; Tenofovir disoproxil below, or any other aspect of the ICR. fumarate. For a complete history of previously DATES: Comments on this ICR should be Estradiol. published Federal Register notices received no later than August 3, 2020. Fish oil triglycerides. related to product-specific guidances, go ADDRESSES: Submit your comments to Fluorometholone. to https://www.regulations.gov and Gilteritinib fumarate. [email protected] or mail the HRSA Glycopyrrolate; Indacaterol maleate. enter Docket No. FDA–2007–D–0369. Information Collection Clearance Ivosidenib. These draft guidances are being Officer, Room 14N136B, 5600 Fishers Latanoprost. issued consistent with FDA’s good Lane, Rockville, Maryland 20857. Metformin hydrochloride. guidance practices regulation (21 CFR FOR FURTHER INFORMATION CONTACT: To Methylphenidate hydrochloride (multiple ref- request more information on the erence listed drugs). 10.115). These draft guidances, when Metronidazole. finalized, will represent the current proposed project or to obtain a copy of Prucalopride succinate. thinking of FDA on, among other things, the data collection plans and draft Revefenacin. the product-specific design of BE instruments, email [email protected] Sodium zirconium cyclosilicate. studies to support ANDAs. They do not or call Lisa Wright-Solomon, the HRSA Tafenoquine succinate. establish any rights for any person and Information Collection Clearance Officer Talazoparib tosylate. at (301) 443–1984. Tretinoin. are not binding on FDA or the public. Triclabendazole. You can use an alternative approach if SUPPLEMENTARY INFORMATION: When it satisfies the requirements of the submitting comments or requesting III. Drug Products for Which Revised applicable statutes and regulations. information, please include the ICR title Draft Product-Specific Guidances are for reference. IV. Electronic Access Available Information Collection Request Title: Substance Use Disorder Treatment and FDA is announcing the availability of Persons with access to the internet Recovery Loan Repayment Program, revised draft product-specific guidances may obtain the draft guidances at either OMB No. 0906—xxxx—New. for industry for drug products https://www.fda.gov/Drugs/Guidance Abstract: The Further Consolidated containing the following active ComplianceRegulatoryInformation/ Appropriations Act, 2020 included no ingredients: Guidances/default.htm or https:// less than $12,000,000 for HRSA’s www.regulations.gov. Bureau of Health Workforce to establish TABLE 2—REVISED DRAFT PRODUCT- Dated: June 1, 2020. the Loan Repayment Program for SPECIFIC GUIDANCES FOR DRUG Lowell J. Schiller, Substance Use Disorder (SUD) PRODUCTS Treatment Workforce. This funding will Principal Associate Commissioner for Policy. allow HRSA to provide the repayment Active ingredient(s) [FR Doc. 2020–12100 Filed 6–3–20; 8:45 am] of education loans for individuals BILLING CODE 4164–01–P Albendazole. working in either a full-time SUD Azelastine hydrochloride; Fluticasone propio- treatment job that involves direct nate. patient care in a Health Professional Buprenorphine. Shortage Area (HPSA) designated for Carglumic acid. Mental Health or a county where the

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average drug overdose death rate and approval. The application requests needed to determine the applicant’s exceeds the national average. will contain supporting information on eligibility to participate in the STAR The program expands the types of the clinical service site, recruitment LRP. In addition, applicants must disciplines eligible to include but not contact and services provided. provide information regarding the loans limited to behavioral health Assistance in completing this for which repayment is being requested. paraprofessionals, occupational application may be obtained through the Likely Respondents: Licensed primary therapists and bachelor trained appropriate HRSA personnel. HRSA care medical, mental and behavioral counselors. The program also expands will use the information collected on health providers, and other the treatment facilities, to include but the applications to determine eligibility paraprofessionals who are employed or not limited to inpatient psychiatric of the facility for the assignment of seeking employment, and are interested facilities, recovery centers, detox health professionals and to verify the in serving underserved populations; facilities, emergency department and need for clinicians. The STAR LRP health care facilities interested in local community jails and detention service site approval will undergo a centers. HHS agrees to repay the recertification after no more than 5 years participating in the STAR LRP, and qualifying educational loans up to to ensure SUD services are being becoming an approved service site; $250,000.00 in return for 6 years of rendered and the desired population is STAR LRP sites providing behavioral service obligation. The forms utilized by receiving care. health care services directly, or through the Substance Use Disorder Treatment Despite the similarity in the titles, the a formal affiliation with a and Recovery (STAR) Loan Repayment STAR LRP is not the existing NHSC comprehensive community-based Program (LRP) include the following: SUD LRP (OMB #0915–0127), which is primary behavioral health setting, The STAR LRP Application, the authorized under Title III of the Public facility providing comprehensive Authorization for Disclosure of Loan Health Service Act. The STAR LRP is a behavioral health services, or various Information form, and the Privacy Act newly authorized Title VII program that substance abuse treatment facility sub- Release Authorization form, if has different service requirements, loan types. applicable. The aforementioned forms repayment protocols, and authorized Burden Statement: Burden in this collect information that is needed for employment facilities. context means the time expended by selecting participants and repaying Need and Proposed Use of the persons to generate, maintain, retain, qualifying educational loans. Information: The need and purpose of disclose, or provide the information Eligible facilities for the STAR LRP this information collection is to obtain requested. This includes the time are facilities that provide in-patient and information that is used to assess an needed to review instructions; to outpatient, ambulatory, primary and STAR LRP applicant’s eligibility and develop, acquire, install, and utilize mental/behavioral health care services qualifications for the program, and to technology and systems for the purpose to populations residing in mental health obtain information for eligible site of collecting, validating, and verifying HPSA or a county where the average applicants. Clinicians interested in information, processing and drug overdose death rate exceeds the participating in the STAR LRP must maintaining information, and disclosing national average. The facilities that may submit an application to the program in and providing information; to train provide related in-patient services may order to participate, and health care personnel and to be able to respond to include, but are not limited to CMS- facilities located in any HPSAs with a collection of information; to search approved Critical Access Hospitals, high overdose rate and MHPSs must data sources; to complete and review Indian Health Service facilities, submit a Site Application to determine the collection of information; and to inpatient rehabilitation centers and the eligibility of sites to participate in transmit or otherwise disclose the psychiatric facilities. HRSA will recruit the STAR LRP. The STAR LRP information. The total annual burden facilities for approval. New facilities application asks for personal, hours estimated for this ICR are must submit an application for review professional and financial information summarized in the table below.

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Average Number of Number of Total burden per Total Form name respondents responses per responses response burden hours respondent (in hours)

STAR LRP Application ...... 300 1 300 .50 150 Authorization for Disclosure of Loan Information Form ...... 300 1 300 .50 150 Privacy Act Release Authorization Form ...... 300 1 300 .50 150 Site Application ...... 400 1 400 1 400

Total ...... 1,600 ...... 1,600 ...... 1000

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HRSA specifically requests comments Paperwork Reduction Act (44 U.S.C. SSATS. I–BHS is also the facility on (1) the necessity and utility of the Chapter 35). To request a copy of these universe for the annual survey of mental proposed information collection for the documents, call the SAMHSA Reports health treatment facilities, the National proper performance of the agency’s Clearance Officer on (240) 276–0361. Mental Health Services Survey (N– functions, (2) the accuracy of the MHSS). I–BHS includes all substance Project: National Survey of Substance estimated burden, (3) ways to enhance abuse treatment and mental health Abuse Treatment Services (N–SSATS) the quality, utility, and clarity of the treatment facilities known to SAMHSA. (OMB No. 0930–0106)—Extension information to be collected, and (4) the (The N–MHSS data collection is covered use of automated collection techniques The Substance Abuse and Mental under OMB No. 0930–0119.) or other forms of information Health Services Administration The information in I–BHS and N– technology to minimize the information (SAMHSA) is requesting an extension of SSATS is needed to assess the nature collection burden. the National Survey of Substance Abuse and extent of these resources, to identify Treatment (N–SSATS) data collection gaps in services, and to provide a Maria G. Button, (OMB No. 0930–0106), which expires Director, Executive Secretariat. database for treatment referrals. Both I– on September 30, 2020. N–SSATS BHS and N–SSATS are components of [FR Doc. 2020–12040 Filed 6–3–20; 8:45 am] provides both national and state-level the Behavioral Health Services BILLING CODE 4165–15–P data on the numbers and types of Information System (BHSIS). patients treated and the characteristics of facilities providing substance abuse The request for OMB approval will DEPARTMENT OF HEALTH AND treatment services. It is conducted include a request to update the I–BHS HUMAN SERVICES under the authority of Section 505 of the facility listing on a continuous basis and Public Health Service Act (42 U.S.C. to conduct the N–SSATS and the Substance Abuse and Mental Health 290aa–4) to meet the specific mandates between cycle N–SSATS (N–SSATS BC) Services Administration for annual information about public and in 2021, 2022, and 2023. The N–SSATS BC is a procedure for collecting services Agency Information Collection private substance abuse treatment providers and the clients they serve. data from newly identified facilities Activities: Submission for OMB between main cycles of the survey and Review; Comment Request This request includes: • Collection of N–SSATS, which is an will be used to improve the listing of Periodically, the Substance Abuse and annual survey of substance abuse treatment facilities in the online Mental Health Services Administration treatment facilities; and Behavioral Health Treatment Services (SAMHSA) will publish a summary of • Updating of the Inventory of Locator. information collection requests under Behavioral Health Services (I–BHS) Estimated annual burden for the OMB review, in compliance with the which is the facility universe for the N– BHSIS activities is shown below:

Responses Type of respondent and activity Number of per Total Hours per Total burden respondents respondent responses response hours

States: I–BHS Online 1 ...... 56 75 4,200 0.08 336

State Subtotal...... 56 ...... 4,200 ...... 336 Facilities: I–BHS application 2 ...... 800 1 800 0.08 64 Augmentation screener ...... 1,300 1 1,300 0.08 104 N–SSATS questionnaire ...... 17,000 1 17,000 0.67 11,333 N–SSATS BC ...... 1,000 1 1,000 0.58 580

Facility Subtotal ...... 20,100 20,100 12,081

Total ...... 20,156 ...... 24,300 ...... 12,417 1 States use the I–BHS Online system to submit information on newly licensed/approved facilities and on changes in facility name, address, status, etc. 2 New facilities complete and submit the online I–BHS application form in order to get listed on the Inventory.

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