81_FR_37724 81 FR 37612 - Reproductive and Environmental Health Network

81 FR 37612 - Reproductive and Environmental Health Network

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 81, Issue 112 (June 10, 2016)

Page Range37612-37613
FR Document2016-13784

HRSA announces the award of an extension in the amount of $1,100,000 for the Reproductive and Environmental Health Network (REHN) cooperative agreement. The purpose of the REHN is to improve maternal and fetal health outcomes by providing evidence-based information on the safety of exposures in pregnancy and lactation. The extension will permit the Organization of Teratology Information Specialists (OTIS), the cooperative agreement awardee, during the budget period of 9/1/ 2016-8/31/2017, to continue to provide evidence-based information on the safety of exposures in pregnancy and lactation through individualized risk-assessments and counseling services, developing and disseminating the most current education to providers and the public, improving access to information for hard-to-reach populations, and supporting a national network of resources with centers accessible to each of the 10 HRSA regions.

Federal Register, Volume 81 Issue 112 (Friday, June 10, 2016) 
[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37612-37613]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13784]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Reproductive and Environmental Health Network

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice of a Single-Award Deviation from Competition 
Requirements for the Reproductive and Environmental Health Network.

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SUMMARY: HRSA announces the award of an extension in the amount of 
$1,100,000 for the Reproductive and Environmental Health Network (REHN) 
cooperative agreement. The purpose of the REHN is to improve maternal 
and fetal health outcomes by providing evidence-based information on 
the safety of exposures in pregnancy and lactation. The extension will 
permit the Organization of Teratology Information Specialists (OTIS), 
the cooperative agreement awardee, during the budget period of 9/1/
2016-8/31/2017, to continue to provide evidence-based information on 
the safety of exposures in pregnancy and lactation through 
individualized risk-assessments and counseling services, developing and 
disseminating the most current education to providers and the public, 
improving access to information for hard-to-reach populations, and 
supporting a national network of resources with centers accessible to 
each of the 10 HRSA regions.

SUPPLEMENTARY INFORMATION:
    Intended Recipient of the Award: Organization of Teratology 
Information Specialists.
    Amount of Non-Competitive Awards: $1,100,000.
    Period of Supplemental Funding: 9/1/2016-8/31/2017.
    CFDA Number: 93.110.

    Authority: Social Security Act, Title V, Sec.  501(a)(2); (42 
U.S.C. 701(a)(2)).

    Justification: REHN activities are essential to achieving HHS 
Healthy People 2020 goals related to improving preconception care, 
preventing maternal morbidity and mortality, reducing infant mortality, 
and reducing health disparities in perinatal health. During this 
extension period of the budget period (9/1/2016-8/31/2017), MCHB plans 
to issue a new FOA that will align HRSA's work in this area with work 
funded by the Environmental Protection Agency (EPA) and the Centers for 
Disease Control and Prevention's (CDC) through their jointly funded 
Pediatric Environmental Health Specialty Unit Program (PEHSU). Aligning 
REHN and PEHSU will result in a more comprehensive HHS initiative to 
expand access to services and maximize limited resources in this area. 
During this time, OTIS would continue to provide individualized risk-
assessments and counseling services, developing and disseminating the 
most current education to providers and the public, improving access to 
information for hard-to-reach populations, and supporting a national 
network of resources with centers accessible to each of the 10 HRSA 
regions.
    MCHB proposes to initiate a one-time 12 month extension for the 
budget period of 9/1/2016 to 8/31/2017 with $1,100,000 in FY 2016 funds 
to the OTIS REHN cooperative agreement. The extension would allow the 
OTIS to continue to provide evidence-based information on the safety of 
exposures in pregnancy and lactation through individualized risk-
assessments and counseling services, developing and disseminating the 
most current education to providers and the public, improving access to 
information for hard-to-reach populations, and supporting a national 
network of

[[Page 37613]]

resources with centers accessible to each of the 10 HRSA regions.

FOR FURTHER INFORMATION CONTACT: Kathryn McLaughlin, MPH, Division of 
Services for Children with Special Health Needs, Maternal and Child 
Health Bureau, Health Resources and Services Administration, 5600 
Fishers Lane, Room 18W08, Rockville, MD 20852, Phone: (301) 443-6829, 
Email: [email protected].

    Dated: June 3, 2016.
James Macrae,
Acting Administrator.
[FR Doc. 2016-13784 Filed 6-9-16; 8:45 am]
 BILLING CODE 4165-15-P

37612 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices length of a regulatory review period for In its application for patent extension, individualized risk-assessments and a human drug product will include all this applicant seeks 1,577 days of patent counseling services, developing and of the testing phase and approval phase term extension. disseminating the most current as specified in 35 U.S.C. 156(g)(1)(B). education to providers and the public, FDA has approved for marketing the III. Petitions improving access to information for human biological product TANZEUM Anyone with knowledge that any of hard-to-reach populations, and (albiglutide). TANZEUM is indicated as the dates as published are incorrect may supporting a national network of an adjunct to diet and exercise to submit either electronic or written resources with centers accessible to improve glycemic control in adults with comments and ask for a redetermination each of the 10 HRSA regions. type 2 diabetes mellitus. Subsequent to (see DATES). Furthermore, any interested SUPPLEMENTARY INFORMATION: this approval, the U.S. Patent and person may petition FDA for a Intended Recipient of the Award: Trademark Office (USPTO) received a determination regarding whether the Organization of Teratology Information patent term restoration application for applicant for extension acted with due Specialists. TANZEUM (U.S. Patent No. 7,141,547) diligence during the regulatory review from Human Genome Sciences, Inc., period. To meet its burden, the petition Amount of Non-Competitive Awards: and the USPTO requested FDA’s must be timely (see DATES) and contain $1,100,000. assistance in determining this patent’s sufficient facts to merit an FDA Period of Supplemental Funding: 9/1/ eligibility for patent term restoration. In investigation. (See H. Rept. 857, part 1, 2016–8/31/2017. a letter dated May 11, 2015, FDA 98th Cong., 2d sess., pp. 41–42, 1984.) CFDA Number: 93.110. advised the USPTO that this human Petitions should be in the format Authority: Social Security Act, Title V, biological product had undergone a specified in 21 CFR 10.30. § 501(a)(2); (42 U.S.C. 701(a)(2)). regulatory review period and that the Submit petitions electronically to Justification: REHN activities are approval of TANZEUM represented the http://www.regulations.gov at Docket essential to achieving HHS Healthy first permitted commercial marketing or No. FDA–2013–S–0610. Submit written People 2020 goals related to improving use of the product. Thereafter, the petitions (two copies are required) to the preconception care, preventing maternal USPTO requested that FDA determine Division of Dockets Management (HFA– morbidity and mortality, reducing infant the product’s regulatory review period. 305), Food and Drug Administration, mortality, and reducing health 5630 Fishers Lane, Rm. 1061, Rockville, disparities in perinatal health. During II. Determination of Regulatory Review MD 20852. this extension period of the budget Period Dated: June 3, 2016. period (9/1/2016–8/31/2017), MCHB FDA has determined that the applicable regulatory review period for Leslie Kux, plans to issue a new FOA that will align TANZEUM is 3,014 days. Of this time, Associate Commissioner for Policy. HRSA’s work in this area with work 2,557 days occurred during the testing [FR Doc. 2016–13797 Filed 6–9–16; 8:45 am] funded by the Environmental Protection phase of the regulatory review period, BILLING CODE 4164–01–P Agency (EPA) and the Centers for while 457 days occurred during the Disease Control and Prevention’s (CDC) approval phase. These periods of time through their jointly funded Pediatric were derived from the following dates: DEPARTMENT OF HEALTH AND Environmental Health Specialty Unit 1. The date an exemption under HUMAN SERVICES Program (PEHSU). Aligning REHN and section 505(i) of the Federal Food, Drug, PEHSU will result in a more and Cosmetic Act (the FD&C Act) (21 Health Resources and Services comprehensive HHS initiative to U.S.C. 355(i)) became effective: January Administration expand access to services and maximize 15, 2006. FDA has verified the limited resources in this area. During Reproductive and Environmental this time, OTIS would continue to applicant’s claim that the date the Health Network investigational new drug application provide individualized risk-assessments (IND) became effective was on January AGENCY: Health Resources and Services and counseling services, developing and 15, 2006. Administration, HHS. disseminating the most current 2. The date the application was ACTION: Notice of a Single-Award education to providers and the public, initially submitted with respect to the Deviation from Competition improving access to information for human biological product under section Requirements for the Reproductive and hard-to-reach populations, and 351 of the Public Health Service Act (42 Environmental Health Network. supporting a national network of U.S.C. 262): January 14, 2013. The resources with centers accessible to applicant claims January 11, 2013, as SUMMARY: HRSA announces the award each of the 10 HRSA regions. the date the biologics license of an extension in the amount of MCHB proposes to initiate a one-time application (BLA) for TANZEUM (BLA $1,100,000 for the Reproductive and 12 month extension for the budget 125431) was initially submitted. Environmental Health Network (REHN) period of 9/1/2016 to 8/31/2017 with However, FDA records indicate that cooperative agreement. The purpose of $1,100,000 in FY 2016 funds to the BLA 125431 was received by FDA on the REHN is to improve maternal and OTIS REHN cooperative agreement. The January 14, 2013. fetal health outcomes by providing extension would allow the OTIS to 3. The date the application was evidence-based information on the continue to provide evidence-based approved: April 15, 2014. FDA has safety of exposures in pregnancy and information on the safety of exposures asabaliauskas on DSK3SPTVN1PROD with NOTICES verified the applicant’s claim that BLA lactation. The extension will permit the in pregnancy and lactation through 125431 was approved on April 15, 2014. Organization of Teratology Information individualized risk-assessments and This determination of the regulatory Specialists (OTIS), the cooperative counseling services, developing and review period establishes the maximum agreement awardee, during the budget disseminating the most current potential length of a patent extension. period of 9/1/2016–8/31/2017, to education to providers and the public, However, the USPTO applies several continue to provide evidence-based improving access to information for statutory limitations in its calculations information on the safety of exposures hard-to-reach populations, and of the actual period for patent extension. in pregnancy and lactation through supporting a national network of VerDate Sep<11>2014 19:02 Jun 09, 2016 Jkt 238001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\10JNN1.SGM 10JNN1

Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices 37613 resources with centers accessible to Information Collection Request Title: exclusions is collected from and each of the 10 HRSA regions. National Practitioner Data Bank (NPDB) disseminated to eligible entities such as FOR FURTHER INFORMATION CONTACT: Attestation of Reports by Hospitals, licensing boards, hospitals, and other Kathryn McLaughlin, MPH, Division of Medical Malpractice Payers, Health health care entities. It is intended that Services for Children with Special Plans, and Health Centers. NPDB information should be considered Health Needs, Maternal and Child OMB No. 0915–xxxx—New. with other relevant information in Abstract: The NPDB plans to collect evaluating a practitioner’s credentials. Health Bureau, Health Resources and data from hospitals, medical The NPDB outlines specific reporting Services Administration, 5600 Fishers malpractice payers, health plans, and requirements for hospitals, medical Lane, Room 18W08, Rockville, MD certain other health care entities 1 that malpractice payers, health plans, and 20852, Phone: (301) 443–6829, Email: are subject to NPDB reporting health care entities; per 45 CFR 60.7, KMcLaughlin@hrsa.gov. requirements to assist these entities in 60.12, 60.14, 60.15, and 60.16. These Dated: June 3, 2016. understanding and meeting their reporting requirements are further James Macrae, reporting requirements to the NPDB. explained in chapter E of the NPDB e- Acting Administrator. The NPDB currently collects similar Guidebook, which can be found at: [FR Doc. 2016–13784 Filed 6–9–16; 8:45 am] data from state licensing boards on a http://www.npdb.hrsa.gov/resources/ BILLING CODE 4165–15–P regular basis, and this information aboutGuidebooks.jsp. collection request would expand Through a process called Attestation, beyond current reporting activities to hospitals, medical malpractice payers, DEPARTMENT OF HEALTH AND include hospitals, medical malpractice health plans, and certain other health HUMAN SERVICES payers, health plans, and certain health entities will be required to attest that care entities. they understand and have met their Health Resources and Services The NPDB began operation on responsibility to submit all required Administration September 1, 1990. The statutory reports to the NPDB. The Attestation authorities establishing and governing process will be completely automated Agency Information Collection the NPDB are title IV of Public Law through the secure NPDB system Activities: Proposed Collection: Public (Pub. L.) 99–660, the Health Care (https://www.npdb.hrsa.gov), using both Comment Request Quality Improvement Act of 1986, as secure email messaging and system amended, section 5 of the Medicare and notifications to alert entities registered AGENCY: Health Resources and Services Medicaid Patient and Program with the NPDB of their responsibility to Administration, HHS. Protection Act of 1987, Public Law 100– attest. All entities with reporting ACTION: Notice. 93, codified as section 1921 of the requirements and querying access to the Social Security Act, and section 221(a) NPDB must register with the NPDB SUMMARY: In compliance with the of the Health Insurance Portability and before gaining access to the secure requirement for opportunity for public Accountability Act of 1996, Public Law NPDB system for all reporting and comment on proposed data collection 104–191, codified as section 1128E of querying transactions. projects (section 3506(c)(2)(A) of the the Social Security Act. Final Although the Attestation process and Paperwork Reduction Act of 1995), the regulations governing the NPDB are forms are new, the secure NPDB system Health Resources and Services codified at 45 CFR part 60. currently used by hospitals, medical Administration (HRSA) announces Responsibility for NPDB malpractice payers, health plans, and plans to submit an Information implementation and operation resides health care entities to conduct reporting Collection Request (ICR), described in the Bureau of Health Workforce, and querying will not change, ensuring below, to the Office of Management and Health Resources and Services that these entities are familiar with the Budget (OMB). Prior to submitting the Administration, Department of Health interface needed to complete the ICR to OMB, HRSA seeks comments and Human Services (HHS). Attestation process. NPDB will ask these from the public regarding the burden The NPDB acts primarily as a flagging entities to attest their reporting estimate, below, or any other aspect of system; its principal purpose is to compliance every 2 years. If the the ICR. facilitate comprehensive review of organization is responsible for DATES: Comments on this Information practitioners’ professional credentials privileging or credentialing individuals Collection Request must be received no and background. Information on who provide services for other sites, later than August 9, 2016. medical malpractice payments, health- those sites will be included in the ADDRESSES: Submit your comments to related civil judgments, adverse Attestation process. paperwork@hrsa.gov or mail the HRSA licensure actions, adverse clinical The Attestation forms will collect the Information Collection Clearance privileging actions, adverse professional following information: (1) Information Officer, Room 14A39, 5600 Fishers society actions, and Medicare/Medicaid regarding sub-sites and entity Lane, Rockville, MD 20857. relationships; (2) contact information for 1 Unless otherwise noted, the term ‘‘health care the Attesting Official; and (3) a FOR FURTHER INFORMATION CONTACT: To entities’’ refers to health centers whose access and statement attesting whether or not all request more information on the reporting obligations are addressed in the NPDB required reports have been submitted. proposed project or to obtain a copy of statutory and regulatory requirements for health care entities. In this document, ‘‘health center’’ Need and Proposed Use of the the data collection plans and draft Information: The NPDB engages in asabaliauskas on DSK3SPTVN1PROD with NOTICES refers to organizations that receive grants under the instruments, email paperwork@hrsa.gov HRSA Health Center Program as authorized under compliance activities to ensure the or call the HRSA Information Collection section 330 of the Public Health Service Act, as accuracy and completeness of the Clearance Officer at (301) 443–1984. amended (referred to as ‘‘grantees’’) and Federally Qualified Health Center (FQHC) Look-Alike information in the NPDB. Through the SUPPLEMENTARY INFORMATION: When organizations, which meet all the Health Center Attestation process, the NPDB can better submitting comments or requesting Program requirements but do not receive Health determine which hospitals, medical Center Program grants. It does not refer to FQHCs information, please include the that are sponsored by tribal or Urban Indian Health malpractice payers, health plans, and information collection request title for Organizations, except for those that receive Health health care entities are meeting the reference. Center Program grants. reporting requirements, and which of VerDate Sep<11>2014 19:02 Jun 09, 2016 Jkt 238001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\10JNN1.SGM 10JNN1


Document Created: 2018-02-08 07:36:06
Document Modified: 2018-02-08 07:36:06
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of a Single-Award Deviation from Competition Requirements for the Reproductive and Environmental Health Network.
ContactKathryn McLaughlin, MPH, Division of Services for Children with Special Health Needs, Maternal and Child Health Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 18W08, Rockville, MD 20852, Phone: (301) 443-6829, Email: [email protected]
FR Citation81 FR 37612 
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