66568 Federal Register / Vol. 85, No. 203 / Tuesday, October 20, 2020 / Notices

with state and local human trafficking offices). Interview questions will be positive or suspected screening, and the coordinators (or comparable staff focused on how agencies select, train process for initiating specialized members with greatest knowledge about on, and implement screening for human services. human trafficking efforts); small group trafficking, the details of screening Respondents: State and local human interviews with casework supervisors; protocols, and variations in trafficking coordinators, casework and case narrative interviews with implementation. Questions will also supervisors, and caseworkers. caseworkers. address the availability of specialized Annual Burden Estimates The interviews will be conducted by services for children identified as telephone (25 state agencies) and in- trafficking victims or at high risk of Data collection is expected to take person (up to 8 local agencies or trafficking, agency steps based on place over two years.

Number of Number of responses per Average respondents respondent burden per Total burden Annual burden Instrument (total over (total over response (in hours) (in hours) request request (in hours) period) period)

State Human Trafficking Coordinator Telephone Interview Guide ...... 25 1 1.5 37.5 19 Local Human Trafficking Coordinator Interview Guide ...... 8 1 1.5 12 6 Casework Supervisor Group Interview Guide ...... 40 1 1.5 60 30 Caseworker Case Narrative Interview Guide ...... 48 1 1 48 24

Estimated Total Annual Burden to respond and request a hearing indictment in Mr. Komar’s case, filed on Hours: 79. constitutes a waiver of his right to a November 29, 2017, to which Mr. Authority: Section 476(a)(1–2) (42 U.S.C. hearing concerning this matter. Komar pleaded guilty, on or about 676) of the Social Security Act Part E— DATES: This order is applicable October December 7, 2015, Mr. Komar, for the Federal Payments for Foster Care and 20, 2020. purpose of executing a scheme and Adoption Assistance. artifice to defraud, and in attempting to ADDRESSES: Submit applications for do so, knowingly caused the U.S. mail John M. Sweet Jr., termination of debarment to the Dockets to deliver from Mumbai, India, a parcel Management Staff, Food and Drug ACF/OPRE Certifying Officer. containing misbranded drugs. Administration, 5630 Fishers Lane, Rm. [FR Doc. 2020–23160 Filed 10–19–20; 8:45 am] Specifically, the parcel contained 30 1061, Rockville, MD 20852. BILLING CODE 4184–25–P tablets of the unapproved new FOR FURTHER INFORMATION CONTACT: prescription drug bicalutamide and 30 Jaime Espinosa, Division of gelcaps of the unapproved new DEPARTMENT OF HEALTH AND Enforcement, Office of Strategic prescription drug isotretinoin. These HUMAN SERVICES Planning and Operational Policy, Office drugs were misbranded because, as of Regulatory Affairs, Food and Drug Food and Drug Administration contained in the indictment in Mr. Administration, 12420 Parklawn Dr., Komar’s case, they were dispensed to [Docket No. FDA–2020–N–1058] Rockville, MD 20857, 240–402–8743, or consumers without a valid prescription at [email protected]. from a practitioner licensed by law to Keith Komar: Final Debarment Order SUPPLEMENTARY INFORMATION: administer such drugs, and they did not contain labeling bearing adequate AGENCY: Food and Drug Administration, I. Background HHS. directions for use. As detailed in facts ACTION: Notice. Section 306(b)(1)(D) of the FD&C Act contained in counts 1, 2, and 4 of Mr. (21 U.S.C. 335a(b)(1)(D)) permits Komar’s indictment (facts which Mr. SUMMARY: The Food and Drug debarment of an individual from Komar acknowledged responsibility for Administration (FDA) is issuing an importing or offering for import any in his plea agreement), Mr. Komar was order under the Federal Food, Drug, and drug into the United States if FDA finds, part of a criminal conspiracy. As part of Cosmetic Act (FD&C Act) debarring as required by section 306(b)(3)(C) of the this criminal conspiracy, Mr. Komar’s Keith Komar for a period of 5 years from FD&C Act, that the individual has been intent was to fraudulently import this importing or offering for import any convicted of a felony for conduct misbranded bicalutamide and drug into the United States. FDA bases relating to the importation into the isotretinoin and sell them in interstate this order on a finding that Mr. Komar United States of any drug or controlled commerce to customers of Mr. Komar’s was convicted of one felony count substance. On November 7, 2019, Mr. websites. On these websites Mr. Komar under Federal law for mail fraud. The Komar was convicted, as defined in made a number of false statements to factual basis supporting Mr. Komar’s section 306(l)(1) of the FD&C Act, in the potential customers, such as that he conviction, as described below, is U.S. District Court for the Western provided ‘‘high quality, safe, and conduct relating to the importation into District of Pennsylvania, when the court approved medications meeting or the United States of a drug or controlled entered judgment against him for the exceeding the U.S. FDA standard.’’ In substance. Mr. Komar was given notice felony offense of mail fraud in violation addition, Mr. Komar later did in fact of the proposed debarment and was of 18 U.S.C. 1341. cause the introduction and delivery for given an opportunity to request a FDA’s finding that debarment is introduction of misbranded drugs hearing to show why he should not be appropriate is based on the felony (bicalutamide and isotretinoin) into debarred. As of 30 days after receipt of conviction referenced herein. The interstate commerce with the intent to the notice (July 22, 2020), Mr. Komar factual basis for this conviction is as defraud and mislead by selling these had not responded. Mr. Komar’s failure follows: As contained in count 3 of the unapproved new prescription drugs to a

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customer who did not have a years from importing or offering for ADDRESSES: Written comments and prescription for them. A member of the import any drug into the United States, recommendations for the proposed conspiracy caused the customs effective (see DATES). Pursuant to section information collection should be sent declaration on the parcel to falsely 301(cc) of the FD&C Act (21 U.S.C. within 30 days of publication of this report that the parcel contained a health 331(cc)), the importing or offering for notice to www.reginfo.gov/public/do/ product sample with no declared value. import into the United States of any PRAMain. Find this particular As a result of this conviction, FDA drug or controlled substance by, with information collection by selecting sent Mr. Komar, by certified mail on the assistance of, or at the direction of ‘‘Currently under Review—Open for June 11, 2020, a notice proposing to Mr. Komar is a prohibited act. Public Comments’’ or by using the debar him for a 5-year period from Any application by Mr. Komar for search function. importing or offering for import any termination of debarment under section FOR FURTHER INFORMATION CONTACT: To drug into the United States. The 306(d)(1) of the FD&C Act should be request a copy of the clearance requests proposal was based on a finding under identified with Docket No. FDA–2020– submitted to OMB for review, email Lisa section 306(b)(3)(C) of the FD&C Act N–1058 and sent to the Dockets Wright-Solomon, the HRSA Information that Mr. Komar’s felony conviction for Management Staff (see ADDRESSES). The Collection Clearance Officer at one felony count under Federal law for public availability of information in [email protected] or call (301) 443– mail fraud was for conduct relating to these submissions is governed by 21 1984. the importation into the United States of CFR 10.20(j). SUPPLEMENTARY INFORMATION: any drug or controlled substance Publicly available submissions will be Information Collection Request Title: because he illegally caused placed in the docket and will be bicalutamide and isotretinoin to be Maternal Health Portfolio Evaluation viewable at https://www.regulations.gov Design, OMB No. 0906–xxxx [NEW]. introduced in interstate commerce from or at the Dockets Management Staff (see Mumbai, India, by selling to a consumer Abstract: HRSA programs provide ADDRESSES) between 9 a.m. and 4 p.m., health care to people who are who did not have a prescription through Monday through Friday, 240–402–7500. the U.S. mail in violation of 18 U.S.C. geographically isolated, economically, 1341. Dated: October 13, 2020. or medically vulnerable. HRSA In proposing a debarment period, Lauren K. Roth, programs help those in need of high FDA weighed the considerations set Acting Principal Associate Commissioner for quality primary health care, such as forth in section 306(c)(3) of the FD&C Policy. pregnant women and mothers. Act that it considered applicable to Mr. [FR Doc. 2020–23135 Filed 10–19–20; 8:45 am] Improving maternal health outcomes Komar’s offenses and concluded that BILLING CODE 4164–01–P and access to quality maternity care this felony offense warranted the services is a key component of the imposition of a 5-year period of HRSA mission. HRSA’s Maternal and debarment. The proposal informed Mr. DEPARTMENT OF HEALTH AND Child Health Bureau (MCHB) provides Komar of the proposed debarment and HUMAN SERVICES funding to address some of the most offered Mr. Komar an opportunity to urgent issues influencing the high rates request a hearing, providing him 30 Health Resources and Services of maternal mortality. Recent efforts to days from the date of receipt of the letter Administration address persistent disparities in in which to file the request, and advised maternal, infant, and child health have him that failure to request a hearing Agency Information Collection employed a ‘‘life course’’ perspective constituted a waiver of the opportunity Activities: Submission to OMB for and health equity lens focused on health for a hearing and of any contentions Review and Approval; Public Comment promotion and disease prevention. Life concerning this action. Mr. Komar Request; Information Collection course approach can be defined as received the proposal and notice of Request Title: Maternal Health analyzing people’s lives within opportunity for a hearing on June 22, Portfolio Evaluation Design, OMB No. structural, social, and cultural contexts 2020. Mr. Komar failed to request a 0906–xxxx–NEW through a defined sequence of age categories that people are normally hearing within the timeframe prescribed AGENCY: Health Resources and Services expected to pass through as they by regulation and has, therefore, waived Administration (HRSA), Department of progress from birth to death. Health his opportunity for a hearing and Health and Human Services. waived any contentions concerning his equity is defined as the attainment of ACTION: Notice. debarment (21 CFR part 12). the highest level of health for all people. Achieving health equity for pregnant SUMMARY: In compliance with of the II. Findings and Order and postpartum women will require Paperwork Reduction Act of 1995, Therefore, the Assistant attention to barriers in access to quality HRSA has submitted an Information Commissioner, Office of Human and health services and promotion of equal Collection Request (ICR) to the Office of Animal Food Operations, under section opportunities to seek the highest Management and Budget (OMB) for 306(b)(3)(C) of the FD&C Act, under possible level of health and well-being. review and approval. Comments authority delegated to the Assistant Achieving health equity also requires a submitted during the first public review Commissioner, finds that Mr. Keith focus on social determinants of health. of this ICR will be provided to OMB. Komar has been convicted of a felony With this emphasis on improving OMB will accept further comments from under Federal law for conduct relating maternal health across the life course the public during the review and to the importation into the United States and promoting optimal health for all approval period. OMB may act on of any drug or controlled substance. mothers, HRSA is employing a HRSA’s ICR only after the 30 day FDA finds that the offense should be multipronged strategy to address comment period for this notice has accorded a debarment period of 5 years maternal mortality and severe maternal closed. as provided by section 306(c)(2)(A)(iii) morbidity through the following suite of of the FD&C Act. DATES: Comments on this ICR should be programs: As a result of the foregoing finding, received no later than November 19, 1. The State Maternal Health Mr. Komar is debarred for a period of 5 2020. Innovation Program;

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