Proposed Information Collection Activity; Comment Request, 29866-29867 [2017-13726]

Download as PDF 29866 Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices under consideration. At the conclusion of the day, the members will vote and the Committee will make its recommendation(s) to CMS. III. Registration Instructions CMS’ Coverage and Analysis Group is coordinating meeting registration. While there is no registration fee, individuals must register to attend. You may register online at http://www.cms.gov/apps/ events/upcomingevents.asp?str OrderBy=1&type=3 or by phone by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the deadline listed in the DATES section of this notice. Please provide your full name (as it appears on your state-issued driver’s license), address, organization, telephone number(s), fax number, and email address. You will receive a registration confirmation with instructions for your arrival at the CMS complex or you will be notified that the seating capacity has been reached. IV. Security, Building, and Parking Guidelines This meeting will be held in a federal government building; therefore, federal security measures are applicable. The Real ID Act, enacted in 2005, establishes minimum standards for the issuance of state-issued driver’s licenses and identification (ID) cards. It prohibits Federal agencies from accepting an official driver’s license or ID card from a state unless the Department of Homeland Security determines that the state meets these standards. Beginning October 2015, photo IDs (such as a valid driver’s license) issued by a state or territory not in compliance with the Real ID Act will not be accepted as identification to enter Federal buildings. Visitors from these states/territories will need to provide alternative proof of identification (such as a valid passport) to gain entrance into CMS buildings. The current list of states from which a Federal agency may accept driver’s licenses for an official purpose is found at http://www.dhs.gov/real-idenforcement-brief. We recommend that confirmed registrants arrive reasonably early, but no earlier than 45 minutes prior to the start of the meeting, to allow additional time to clear security. Security measures include the following: • Presentation of government-issued photographic identification to the Federal Protective Service or Guard Service personnel. • Inspection of vehicle’s interior and exterior (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection. • Inspection, via metal detector or other applicable means, of all persons entering the building. We note that all items brought into CMS, whether personal or for the purpose of presentation or to support a presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for presentation or to support a presentation. Note: Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 45 minutes prior to the convening of the meeting. All visitors must be escorted in areas other than the lower and first floor levels in the Central Building. V. Collection of Information This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). Authority: 5 U.S.C. App. 2, section 10(a). Dated: June 22, 2017. Kate Goodrich, Director, Center for Clinical Standards and Quality, Centers for Medicare & Medicaid Services. [FR Doc. 2017–13785 Filed 6–29–17; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families [OMB No.: 0970–0422] Proposed Information Collection Activity; Comment Request Title: Adoption and Foster Care Analysis Reporting System for title IV– B and title IV–E (AFCARS). Description: The Adoption and Foster Care Analysis and Reporting System (AFCARS) is mandated by 42 U.S.C. 679. The regulation at 45 CFR 1355 sets forth the requirements of section 479 of the Social Security Act for the collection of uniform, reliable information on children who are under the responsibility of the State or Tribal title IV–B/IV–E agency for placement, care, and adoption. Effective October 1, 2009, section 479B(b) of the Act authorizes direct Federal funding of Indian Tribes, Tribal organizations, and Tribal consortia that choose to operate a foster care, adoption assistance and, at Tribal option, a kinship guardianship assistance program under title IV–E of the Act. The data collected per the requirements at 45 CFR 1355.40 will end September 30, 2019. On October 1, 2019 the data collection will be replaced by the requirements in 45 CFR 1355.41—44, as reflected in the final rule published in the Federal Register on December 14, 2016 (81 FR 90524). The data collected will inform State/ Tribal/Federal policy decisions, program management, and responses to Congressional and Departmental inquiries. Specifically, the data are used for short/long-term budget projections, trend analysis, child and family service reviews, and to target areas for improved technical assistance. The data will provide information about foster care placements, adoptive parents, length of time in care, delays in termination of parental rights and placement for adoption. Respondents: Title IV–E State and Tribal Child Welfare Agencies. mstockstill on DSK30JT082PROD with NOTICES ANNUAL BURDEN ESTIMATES Number of respondents Instrument AFCARS .......................................................................................................... VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Number of responses per respondent 59 E:\FR\FM\30JNN1.SGM 2 30JNN1 Average burden hours per response 2,188 Total burden hours 258,215 Federal Register / Vol. 82, No. 125 / Friday, June 30, 2017 / Notices Estimated Total Annual Burden Hours: 258,215. In compliance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. Chap 35), the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington DC 20201. Attn: ACF Reports Clearance Officer. Email address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Robert Sargis, Reports Clearance Officer. [FR Doc. 2017–13726 Filed 6–29–17; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–3224] Authorization of Emergency Use of an Injectable Treatment for Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) Poisoning; Availability AGENCY: Food and Drug Administration, HHS. mstockstill on DSK30JT082PROD with NOTICES ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an injectable treatment for nerve agent or certain insecticide (organophosphorus and/or carbamate) SUMMARY: VerDate Sep<11>2014 17:32 Jun 29, 2017 Jkt 241001 poisoning. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the U.S. Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized injectable treatment. The Authorization follows the April 11, 2017, determination by the Department of Health and Human Services (HHS) Secretary that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves nerve agents or certain insecticides (organophosphorus and/or carbamate). On the basis of such determination, the HHS Secretary declared on April 11, 2017, that circumstances exist justifying the authorization of emergency use of injectable treatments for nerve agent or certain insecticide (organophosphorus and/or carbamate) poisoning, subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document. DATES: The Authorization is effective as of April 11, 2017. ADDRESSES: Submit written requests for single copies of the EUA to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the Authorization may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the Authorization. FOR FURTHER INFORMATION CONTACT: Carmen Maher, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993–0002, 301–796–8510. SUPPLEMENTARY INFORMATION: I. Background Section 564 of the FD&C Act (21 U.S.C. 360bbb–3) as amended by the Project BioShield Act of 2004 (Pub. L. 108–276) and the Pandemic and AllHazards Preparedness Reauthorization Act of 2013 (Pub. L. 113–5) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 29867 an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help assure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, nuclear, or radiological agents when there are no adequate, approved, and available alternatives. Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces of attack with a biological, chemical, radiological, or nuclear agent or agents; (3) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or (4) the identification of a material threat by the Secretary of Homeland Security under section 319F–2 of the Public Health Service (PHS) Act (42 U.S.C. 247d–6b) sufficient to affect national security or the health and security of U.S. citizens living abroad. Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the Federal Register a notice of each authorization, and each termination or revocation of an authorization, and an explanation of the reasons for the action. Section 564 of the FD&C Act permits FDA to authorize the introduction into interstate commerce of a drug, device, or biological product intended for use when the Secretary of HHS has declared that circumstances E:\FR\FM\30JNN1.SGM 30JNN1

Agencies

[Federal Register Volume 82, Number 125 (Friday, June 30, 2017)]
[Notices]
[Pages 29866-29867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13726]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families

[OMB No.: 0970-0422]


Proposed Information Collection Activity; Comment Request

    Title: Adoption and Foster Care Analysis Reporting System for title 
IV-B and title IV-E (AFCARS).
    Description: The Adoption and Foster Care Analysis and Reporting 
System (AFCARS) is mandated by 42 U.S.C. 679. The regulation at 45 CFR 
1355 sets forth the requirements of section 479 of the Social Security 
Act for the collection of uniform, reliable information on children who 
are under the responsibility of the State or Tribal title IV-B/IV-E 
agency for placement, care, and adoption. Effective October 1, 2009, 
section 479B(b) of the Act authorizes direct Federal funding of Indian 
Tribes, Tribal organizations, and Tribal consortia that choose to 
operate a foster care, adoption assistance and, at Tribal option, a 
kinship guardianship assistance program under title IV-E of the Act. 
The data collected per the requirements at 45 CFR 1355.40 will end 
September 30, 2019. On October 1, 2019 the data collection will be 
replaced by the requirements in 45 CFR 1355.41--44, as reflected in the 
final rule published in the Federal Register on December 14, 2016 (81 
FR 90524).
    The data collected will inform State/Tribal/Federal policy 
decisions, program management, and responses to Congressional and 
Departmental inquiries. Specifically, the data are used for short/long-
term budget projections, trend analysis, child and family service 
reviews, and to target areas for improved technical assistance. The 
data will provide information about foster care placements, adoptive 
parents, length of time in care, delays in termination of parental 
rights and placement for adoption.
    Respondents: Title IV-E State and Tribal Child Welfare Agencies.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                   Instrument                        Number of     responses per     hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
AFCARS..........................................              59               2           2,188         258,215
----------------------------------------------------------------------------------------------------------------


[[Page 29867]]

    Estimated Total Annual Burden Hours: 258,215.
    In compliance with the requirements of the Paperwork Reduction Act 
of 1995 (Pub. L. 104-13, 44 U.S.C. Chap 35), the Administration for 
Children and Families is soliciting public comment on the specific 
aspects of the information collection described above. Copies of the 
proposed collection of information can be obtained and comments may be 
forwarded by writing to the Administration for Children and Families, 
Office of Planning, Research and Evaluation, 330 C Street SW., 
Washington DC 20201. Attn: ACF Reports Clearance Officer. Email 
address: infocollection@acf.hhs.gov. All requests should be identified 
by the title of the information collection.
    The Department specifically requests comments on: (a) Whether the 
proposed collection of information is necessary for the proper 
performance of the functions of the agency, including whether the 
information shall have practical utility; (b) the accuracy of the 
agency's estimate of the burden of the proposed collection of 
information; (c) the quality, utility, and clarity of the information 
to be collected; and (d) ways to minimize the burden of the collection 
of information on respondents, including through the use of automated 
collection techniques or other forms of information technology. 
Consideration will be given to comments and suggestions submitted 
within 60 days of this publication.

Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2017-13726 Filed 6-29-17; 8:45 am]
 BILLING CODE 4184-01-P