Proposed Information Collection Activity; Comment Request, 61819-61820 [2015-25998]

Download as PDF Federal Register / Vol. 80, No. 198 / Wednesday, October 14, 2015 / Notices [FR Doc. 2015–26012 Filed 10–13–15; 8:45 am] Mailstop A–19, 1600 Clifton Road NE., Atlanta, Georgia 30329. Instructions: All submissions received must include the agency name and docket number. All relevant comments received will be posted without change to http://regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to http://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Skip Wolfe (crw4@cdc.gov), National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Mailstop A–19, 1600 Clifton Road, NE., Atlanta, Georgia 30329. BILLING CODE 6820–EP–P SUPPLEMENTARY INFORMATION: techniques or other forms of information technology. Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202–501–4755. Please cite OMB Control No. 9000–0076, Novation/Change of Name Requirements, in all correspondence. Edward Loeb, Acting Director, Federal Acquisition Policy Division, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC–2015–0059] Proposed Revised Vaccine Information Materials for Meningococcal ACWY and Serogroup B Meningococcal Vaccines Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. AGENCY: Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa–26), the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) develops vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. HHS/CDC seeks written comment on the proposed updated vaccine information statements for meningococcal ACWY and serogroup B meningococcal vaccines. SUMMARY: Written comments must be received on or before December 14, 2015. DATES: You may submit comments, identified by Docket No. CDC–2015– 0059, by any of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. • Mail: Written comments should be addressed to Suzanne Johnson-DeLeon, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, tkelley on DSK3SPTVN1PROD with NOTICES ADDRESSES: VerDate Sep<11>2014 16:39 Oct 13, 2015 Jkt 238001 The National Childhood Vaccine Injury Act of 1986 (Pub. L. 99–660), as amended by section 708 of Public Law 103–183, added section 2126 to the Public Health Service Act. Section 2126, codified at 42 U.S.C. 300aa–26, requires the Secretary of Health and Human Services to develop and disseminate vaccine information materials for distribution by all health care providers in the United States to any patient (or to the parent or legal representative in the case of a child) receiving vaccines covered under the National Vaccine Injury Compensation Program (VICP). Development and revision of the vaccine information materials, also known as Vaccine Information Statements (VIS), have been delegated by the Secretary to the Centers for Disease Control and Prevention (CDC). Section 2126 requires that the materials be developed, or revised, after notice to the public, with a 60-day comment period, and in consultation with the Advisory Commission on Childhood Vaccines, appropriate health care provider and parent organizations, and the Food and Drug Administration. The law also requires that the information contained in the materials be based on available data and information, be presented in understandable terms, and include: (1) A concise description of the benefits of the vaccine, (2) A concise description of the risks associated with the vaccine, (3) A statement of the availability of the National Vaccine Injury Compensation Program, and (4) Such other relevant information as may be determined by the Secretary. The vaccines initially covered under the National Vaccine Injury Compensation Program were diphtheria, tetanus, pertussis, measles, mumps, rubella and poliomyelitis vaccines. Since April 15, 1992, any health care PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 61819 provider in the United States who intends to administer one of these covered vaccines is required to provide copies of the relevant vaccine information materials prior to administration of any of these vaccines. Since then, the following vaccines have been added to the National Vaccine Injury Compensation Program, requiring use of vaccine information materials for them as well: Hepatitis B, Haemophilus influenzae type b (Hib), varicella (chickenpox), pneumococcal conjugate, rotavirus, hepatitis A, meningococcal, human papillomavirus (HPV), and seasonal influenza vaccines. Instructions for use of the vaccine information materials are found on the CDC Web site at: http://www.cdc.gov/ vaccines/hcp/vis/index.html. HHS/CDC is proposing updated versions of the meningococcal ACWY and serogroup B meningococcal vaccine information statements. The vaccine information materials referenced in this notice are being developed in consultation with the Advisory Commission on Childhood Vaccines, the Food and Drug Administration, and parent and health care provider groups. We invite written comment on the proposed vaccine information materials entitled ‘‘Meningococcal ACWY Vaccines (MenACWY and MPSV4): What You Need to Know’’ and ‘‘Serogroup B Meningococcal Vaccine (MenB): What You Need to Know.’’ Copies of the proposed vaccine information materials are available at http://www.regulations.gov (see Docket Number CDC–2015–0059).Comments submitted will be considered in finalizing these materials. When the final materials are published in the Federal Register, the notice will include an effective date for their mandatory use. Dated: October 7, 2015. Sandra Cashman, Acting Director, Division of the Executive Secretariat, Office of the Chief of Staff, Centers for Disease Control and Prevention. [FR Doc. 2015–26076 Filed 10–13–15; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects: Title: Annual Survey of Refugees (Form ORR–9) E:\FR\FM\14OCN1.SGM 14OCN1 61820 Federal Register / Vol. 80, No. 198 / Wednesday, October 14, 2015 / Notices OMB No.: 0970–0033 Description: The Annual Survey of Refugees collects information on the social and economic characteristics of a random sample of refugees, Amerasians, and entrants who arrived in the United States in the five years prior to the date of the survey. The survey focuses on employment and other training, labor force participation, and welfare utilization rates. From the responses, the Office of Refugee Resettlement reports on the economic adjustment of refugees to the American economy. These data are used by Congress in its annual deliberations on refugee admissions and funding and by program managers in formulating policies for the future direction of the Refugee Resettlement Program. Respondents: Refugees, Amerasians, and entrants ANNUAL BURDEN ESTIMATES Number of respondents Instrument Number of responses per respondent Average burden hours per response Total burden hours ORR–9 Annual Survey of Refugees ............................................................... Request for Participation Letter ....................................................................... 2,000 2,000 1 1 0.62 0.05 1,240 100 Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 1,340 tkelley on DSK3SPTVN1PROD with NOTICES In compliance with the requirements of section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, 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, 370 L’Enfant Promenade, SW., Washington, DC 20447, 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. 2015–25998 Filed 10–13–15; 8:45 am] BILLING CODE 4184–01–P VerDate Sep<11>2014 16:39 Oct 13, 2015 Jkt 238001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–3419] General Considerations for Animal Studies for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘General Considerations for Animal Studies for Medical Devices.’’ FDA has developed this guidance document to assist industry in designing evaluation strategies for, and reporting the results of, animal studies for medical devices. The intent of this draft guidance is to provide a reference of best practices for the approach to, and conduct of, animal studies, and the presentation of animal study data intended to demonstrate that the device under study is sufficiently safe for early human experience (e.g., to support an investigational device exemption (IDE) application) or to demonstrate device safety in support of a marketing application, while incorporating modern animal care and use strategies. This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 12, 2016. SUMMARY: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, E:\FR\FM\14OCN1.SGM 14OCN1

Agencies

[Federal Register Volume 80, Number 198 (Wednesday, October 14, 2015)]
[Notices]
[Pages 61819-61820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25998]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Proposed Information Collection Activity; Comment Request

    Proposed Projects:
    Title: Annual Survey of Refugees (Form ORR-9)

[[Page 61820]]

    OMB No.: 0970-0033
    Description: The Annual Survey of Refugees collects information on 
the social and economic characteristics of a random sample of refugees, 
Amerasians, and entrants who arrived in the United States in the five 
years prior to the date of the survey. The survey focuses on employment 
and other training, labor force participation, and welfare utilization 
rates. From the responses, the Office of Refugee Resettlement reports 
on the economic adjustment of refugees to the American economy. These 
data are used by Congress in its annual deliberations on refugee 
admissions and funding and by program managers in formulating policies 
for the future direction of the Refugee Resettlement Program.
    Respondents: Refugees, Amerasians, and entrants

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                   Instrument                        Number of     responses per     hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
ORR-9 Annual Survey of Refugees.................           2,000               1            0.62           1,240
Request for Participation Letter................           2,000               1            0.05             100
                                                 ---------------------------------------------------------------
    Estimated Total Annual Burden Hours.........  ..............  ..............  ..............           1,340
----------------------------------------------------------------------------------------------------------------

    In compliance with the requirements of section 506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, 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, 370 L'Enfant Promenade, SW., 
Washington, DC 20447, 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. 2015-25998 Filed 10-13-15; 8:45 am]
BILLING CODE 4184-01-P