22692 Federal Register /Vol. 83, No. 95/Wednesday, …

1 22692 Federal Register / Vol. 83, No. 95 / Wednesday, May 16, 2018 / Notices relationships between grantees and network to depict how grantee and and identify potential opportunities for subrecipients. With this data, the subrecipient organizations collaborate improving the efficiency of the network. contractor, to inform ASPE and ACF, with one another through TVAP to ASPE anticipates completion of all data will build a social/organizational better understand the existing network collection activities by October 2018. ESTIMATED ANNUALIZED BURDEN TABLE. Average Number Number of burden per Total burden Type of respondent responses per respondents response hours respondent (in hours).

2 TVAP grantees .. 3 1 45/60 TVAP Subrecipients .. 253 1 45/60 Total .. 256 1 45/60 192. Terry Clark, SUPPLEMENTARY INFORMATION: The increase fair market access for American Asst. Paperwork Reduction Act Reports United States is the world's leader in innovators. Furthermore, HHS seeks to Clearance Officer, Office of the Secretary. biopharmaceutical innovation. identify when developed nations are [FR Doc. 2018 10394 Filed 5 15 18; 8:45 am] American innovation has improved paying less for drugs than the prices BILLING CODE 4151 05 P health and quality of life for billions of paid by Federal health programs, and people, and was made possible by our correct these inequities through better intellectual property system, decades of negotiation.

3 DEPARTMENT OF HEALTH AND government and privately-funded HHS has already acted to increase the HUMAN SERVICES research, strong capital markets, and the affordability of medicines for millions of world's largest scientific research base. our citizens, but is also going much Office of the Secretary By rewarding innovation through patent further in response to President Trump's and data protection, American call to action. Through the work of the RIN 0991 ZA49. companies hold the intellectual Food and Drug Administration and the HHS Blueprint to Lower Drug Prices property rights for most new, and Centers for Medicare & Medicaid and Reduce Out-of-Pocket Costs potentially life changing, medicines.

4 Services, HHS has tremendous ability to Our regulatory system is the most change how drugs are developed and AGENCY: Department of Health and rigorous in the world, ensuring the paid for in the United States. Human Services. safety and efficacy of drugs for The status quo is no longer ACTION: Policy Statement; Request for American patients. Medicare, Medicaid, acceptable. Millions of Americans face information. other Federal health programs, and soaring drug prices and higher out-of- private payers ensure Americans have pocket costs, while manufacturers and SUMMARY: Through this request for access to medicines, from innovative middlemen such as pharmacy benefit information, HHS seeks comment from new cures, to generic versions of managers (PBMs) and distributors interested parties to help shape future medications that have markedly benefit from rising list prices and their policy development and agency action.

5 Lowered costs for consumers. resulting higher rebates and DATES: Comments must be submitted on As part of President Trump's bold administrative fees. An unprecedented or before July 16, 2018. plan to put American patients first, the re-examination of the whole system and ADDRESSES: You may submit comments Department of Health and Human opportunities for reform is long in one of three ways (please choose only Services has developed a overdue. We believe a national focus on one of the ways listed): comprehensive blueprint that addresses lowering list prices and out-of-pocket 1. Electronically. You may submit many of the challenges and costs has the potential to create new and electronic comments to http:// opportunities impacting American disruptive alternatives to the current Follow the patients and consumers.

6 The blueprint system, while maintaining its many Submit a comment'' instructions. covers multiple areas including, but not virtues. It is time to realign the system 2. By regular mail. You may mail limited to: in a way that promotes the development Improving competition and ending of affordable innovations that improve written comments to the following the gaming of the regulatory process, health outcomes and lower both out-of- address ONLY: Department of Health supporting better negotiation of and Human Services, 200 Independence pocket cost and the total cost of care. drug discounts in government-funded Through this request for information, Ave. SW, Room 600E, Washington, DC insurance programs, 20201.

7 HHS seeks comment from interested creating incentives for parties to help shape future policy Please allow sufficient time for mailed pharmaceutical companies to lower list comments to be received before the development and agency action. prices, and, close of the comment period. reducing out-of-pocket spending for Table of Contents: 3. By express or overnight mail. You sradovich on DSK3 GMQ082 PROD with NOTICES. patients at the pharmacy and other sites may send written comments to the of care. I. Previous Actions by the Trump following address ONLY: Department of HHS also recognizes that achieving Administration Health and Human Services, 200 A. Increasing Competition the goal of putting American patients B.

8 Better Negotiation Independence Ave. SW, Room 600E, first will require interagency C. Creating Incentives to Lower List Prices Washington, DC 20201. collaboration on pharmaceutical trade D. Reducing Patient Out-of-Pocket FOR FURTHER INFORMATION CONTACT: John policies that promote innovation, and Spending O'Brien, (202) 690 7886. are transparent, nondiscriminatory, and II. Responding to President Trump's Call to VerDate Sep<11>2014 17:34 May 15, 2018 Jkt 244001 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 E:\FR\FM\ 16 MYN1. Federal Register / Vol. 83, No. 95 / Wednesday, May 16, 2018 / Notices 22693. Action taken steps to prioritize its review of Finalizing changes to the Medicare A.

9 Increasing Competition generic drug applications; issued Prescription Drug Program in the 2019. B. Better Negotiation guidance to improve efficiencies in the Part C and Part D regulation allowing for C. Creating Incentives to Lower List Prices development, review, and approval faster mid-year substitution of generic D. Reducing Patient Out-of-Pocket Spending processes for generic drugs, including drugs onto formularies. III. Solicitation of Comments complex generic drugs; and issued Proposing in the President's A. Increasing Competition guidance to further streamline the FY2019 Budget 1 a 5-part plan to B. Better Negotiation submission and review process for modernize the Medicare Part D program, C.

10 Creating Incentives to Lower List Prices shared system REMS, and to allow a portion of which includes enhancing D. Reducing Patient Out-of-Pocket collective submissions to streamline the Part D plans' negotiating power with Spending review of shared Risk Evaluation and manufacturers by changing Part D plan E. Additional Feedback Mitigation Strategies (REMS). formulary standards to require a IV. Collection of Information Requirements FDA also announced it will minimum of one drug per category or I. Previous Actions by the Trump facilitate opportunities for enhanced class rather than two. We note that the Administration information sharing between 5-part plan is intended to be manufacturers, doctors, patients and implemented together, as eliminating The President has consistently insurers to improve patient access to even one piece of the package emphasized the need to reduce the price medical products, including through significantly changes the proposal's of prescription drugs.