Proposed Vaccine Information Materials for HPV (Human Papillomavirus) Gardasil®-9 Vaccine, 64002-64003 [2015-26868]

Download as PDF tkelley on DSK3SPTVN1PROD with NOTICES 64002 Federal Register / Vol. 80, No. 204 / Thursday, October 22, 2015 / Notices foreign banks (12 CFR 211.24(f)). BSA– SARs are exempt from FOIA disclosure by 31 U.S.C. 5319, which specifically provides that SARS ‘‘are exempt from disclosure under section 552 of title 5’’, and FOIA exemption 3, 5 U.S.C. 552(b)(3) (matters ‘‘specifically exempted from disclosure by statute’’). Abstract: Since 1996, the Federal Reserve Board, the Office of the Comptroller of the Currency, the Federal Deposit Insurance Corporation, the National Credit Union Administration, and the Department of the Treasury’s Financial Crimes Enforcement Network have required certain types of financial institutions to report known or suspected violations of law and suspicious transactions. To fulfill these requirements, supervised banking organizations file SARs. Law enforcement agencies use the information submitted on the reporting form to initiate investigations and the Federal Reserve uses the information in the examination and oversight of supervised institutions. 3. Report title: Domestic Branch Notification. Agency form number: FR 4001. OMB control number: 7100–0097. Frequency: On occasion. Reporters: SMBs. Estimated annual reporting hours: 131 hours. Estimated average hours per response: 30 minutes for expedited notifications and 1 hour for nonexpedited notifications. Number of respondents: 60 expedited and 101 nonexpedited. General description of report: Section 9(3) of the Federal Reserve Act, (12 U.S.C. 321), requires that SMBs obtain prior Federal Reserve approval before establishing a domestic branch. This requirement is implemented by the provisions of Section 208.6 of the Board’s Regulation H, (12 CFR 208.6). The obligation of SMBs to request prior approval of the appropriate supervising Reserve Bank in order to establish a domestic branch is mandatory. The individual respondent information in the notification is not considered confidential. Abstract: The Federal Reserve Act and Regulation H require an SMB to seek prior approval of the Federal Reserve System before establishing or acquiring a domestic branch. Such requests for approval must be filed as notifications at the appropriate Reserve Bank for the SMB. Due to the limited information that an SMB generally has to provide for branch proposals, there is no formal reporting form for a domestic branch notification. An SMB is required to notify the Federal Reserve by letter of its VerDate Sep<11>2014 18:05 Oct 21, 2015 Jkt 238001 intent to establish one or more new branches and provide with the letter evidence that public notice of the proposed branch(es) has been published by the SMB in the appropriate newspaper(s). The Federal Reserve uses the information provided to fulfill its statutory obligation to review any public comment on proposed branches before acting on the proposals and otherwise to supervise SMBs. 4. Report title: Disclosure Requirements in Connection With Subpart H of Regulation H (Consumer Protections in Sales of Insurance). Agency form number: Reg H–7. OMB control number: 7100–0298. Frequency: On occasion. Reporters: State member banks. Estimated annual reporting hours: 13,372 hours. Estimated average hours per response: 1.5 minutes Number of respondents: 849. General description of report: Section 305 of the Gramm-Leach-Bliley Act of 1999 requires that the Federal Reserve and the other federal banking agencies issue joint regulations applicable to retail sales practices, solicitations, advertising, or offers of insurance by depository institutions. (12 U.S.C. 1831x) Subpart H of the Federal Reserve’s Regulation H, Consumer Protection in Sales of Insurance, implements section 305 on behalf of the Federal Reserve, and provides for the disclosures outlined above. (12 CFR part 208, subpart H) The obligation of SMBs to make these disclosures is mandatory. Since the Federal Reserve does not collect any information, no issue of confidentiality normally arises. Abstract: Subpart H of Regulation H was adopted pursuant to section 305 of the Gramm-Leach-Bliley Act of 1999, which required the federal banking agencies to issue joint regulations governing retail sales practices, solicitations, advertising, and offers of insurance by, on behalf of, or at the offices of insured depository institutions. The insurance consumer protection rules in Regulation H require depository institutions to prepare and provide certain disclosures to consumers. Covered persons are required to make certain disclosures before the completion of the initial sale of an insurance product or annuity to a consumer and at the time a consumer applies for an extension of credit in connection with which and insurance product or annuity is solicited, offered, or sold. PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Board of Governors of the Federal Reserve System, October 19, 2015. Robert deV. Frierson Secretary of the Board. [FR Doc. 2015–26817 Filed 10–21–15; 8:45 am] BILLING CODE 6210–01–P FEDERAL RETIREMENT THRIFT INVESTMENT BOARD Sunshine Act; Notice of ETAC Meeting MATTERS TO BE CONSIDERED AGENDA Employee Thrift Advisory Council October 29, 2015, 1:00 p.m., 10th Floor Board Meeting Room, 77 K Street NE., Washington, DC 20002. 1. Approval of the minutes of the August 6, 2015 ETAC meeting 2. Thrift Savings Fund Statistics 3. Auto Escalation 4. Choosing a Financial Vendor 5. Investment Policy 6. New Business CONTACT PERSON FOR MORE INFORMATION: Kimberly Weaver, Director, Office of External Affairs, (202) 942–1640. Dated: October 19, 2015. Megan Grumbine, Deputy General Counsel, Federal Retirement Thrift Investment Board. [FR Doc. 2015–26941 Filed 10–20–15; 11:15 am] BILLING CODE 6760–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC–2015–0089] Proposed Vaccine Information Materials for HPV (Human Papillomavirus) Gardasil®-9 Vaccine 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 vaccine information statement for HPV (human papillomavirus) Gardasil®-9 vaccine. SUMMARY: E:\FR\FM\22OCN1.SGM 22OCN1 Federal Register / Vol. 80, No. 204 / Thursday, October 22, 2015 / Notices Written comments must be received on or before December 21, 2015. ADDRESSES: You may submit comments, identified by Docket No. CDC–2015– 0089, by any of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • Mail: Written comments should be addressed to Suzanne Johnson-DeLeon (msj1@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. Instructions: All submissions received must include the agency name and docket number. All relevant comments received will be posted without change to https://regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to https://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. SUPPLEMENTARY INFORMATION: 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: tkelley on DSK3SPTVN1PROD with NOTICES DATES: VerDate Sep<11>2014 18:05 Oct 21, 2015 Jkt 238001 (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 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: https://www.cdc.gov/ vaccines/hcp/vis/. HHS/CDC is proposing to finalize the HPV (Human Papillomavirus) Gardasil®-9 vaccine information statement. 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 ‘‘Proposed Vaccine Information Materials for HPV (Human Papillomavirus) Gardasil®-9 Vaccine.’’ Copies of the proposed vaccine information materials are available at https://www.regulations.gov (see Docket Number CDC–2015–0089). 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 19, 2015. Sandra Cashman, Acting Director, Division of the Executive Secretariat, Office of the Chief of Staff, Centers for Disease Control and Prevention. [FR Doc. 2015–26868 Filed 10–21–15; 8:45 am] BILLING CODE 4163–18–P PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 64003 DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects: Title: Federal Tax Refund Offset, Administrative Offset, and Passport Denial. OMB No.: 0970–0161. Description: The Federal Offset programs (Federal Tax Refund Offset and Administrative Offset) collect pastdue child and spousal support by intercepting certain Federal payments, including Federal tax refunds, of parents who have been ordered to pay support and are delinquent. The Federal Offset programs consist of a cooperative effort among the Department of the Treasury’s Bureau of the Fiscal Service, the Federal Office of Child Support Enforcement (OCSE), and State child support agencies. The Passport Denial program reports noncustodial parents who owe child and spousal support above a threshold to the Department of State, which will then deny passports. On an ongoing basis, State child support agencies submit names, Social Security numbers, and the amount(s) of past-due child and spousal support of noncustodial parents who are delinquent in making payments to OCSE. Federal laws authorize information collection activities pertaining to the Federal Offset and Passport Denial programs and require State child support agencies to submit information pertaining to past-due support that meets specific criteria and to comply with Annual Certification Letter requirements: (1) 42 U.S.C. 652(b), 42 U.S.C. 664, and 26 U.S.C. 6402(c), for the offset of the Federal tax refund of the noncustodial parent; (2) 31 U.S.C. 3701 et seq. and 31 U.S.C. 3716(h), for the offset of the Federal payments other than Federal tax refunds of the noncustodial parent; and (3) 42 U.S.C. 654(31) and 42 U.S.C. 652(k), to Department of State for the denial, revocation, restriction, or limitation of the passport of the noncustodial parent. Respondents: State Child Support Agencies. E:\FR\FM\22OCN1.SGM 22OCN1

Agencies

[Federal Register Volume 80, Number 204 (Thursday, October 22, 2015)]
[Notices]
[Pages 64002-64003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26868]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2015-0089]


Proposed Vaccine Information Materials for HPV (Human 
Papillomavirus) Gardasil[supreg]-9 Vaccine

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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

SUMMARY: 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 
vaccine information statement for HPV (human papillomavirus) 
Gardasil[supreg]-9 vaccine.

[[Page 64003]]


DATES: Written comments must be received on or before December 21, 
2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0089, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Written comments should be addressed to Suzanne 
Johnson-DeLeon (msj1@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.
    Instructions: All submissions received must include the agency name 
and docket number. All relevant comments received will be posted 
without change to https://regulations.gov, including any personal 
information provided. For access to the docket to read background 
documents or comments received, go to https://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.

SUPPLEMENTARY INFORMATION: 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 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: https://www.cdc.gov/vaccines/hcp/vis/.
    HHS/CDC is proposing to finalize the HPV (Human Papillomavirus) 
Gardasil[supreg]-9 vaccine information statement.
    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 ``Proposed Vaccine Information Materials for HPV 
(Human Papillomavirus) Gardasil[supreg]-9 Vaccine.'' Copies of the 
proposed vaccine information materials are available at https://www.regulations.gov (see Docket Number CDC-2015-0089). 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 19, 2015.
Sandra Cashman,
Acting Director, Division of the Executive Secretariat, Office of the 
Chief of Staff, Centers for Disease Control and Prevention.
[FR Doc. 2015-26868 Filed 10-21-15; 8:45 am]
BILLING CODE 4163-18-P

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