81 FR 23297 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 76 (April 20, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 76 (April 20, 2016)
| Page Range | 23297-23299 | |
| FR Document | 2016-09190 |
[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)] [Notices] [Pages 23297-23299] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-09190] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-16-1067] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed projects or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected]. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice. Proposed Project Improving the Impact of Laboratory Practice Guidelines (LPGs): A New Paradigm for Metrics--College of American Pathologists (OMB Control No. 0920-1067)--Revision--Center for Surveillance, Epidemiology and [[Page 23298]] Laboratory Services (CSELS), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Centers for Disease Control and Prevention (CDC) funded the College of American Pathologists (CAP) as one of three professional organizations in 5-year cooperative agreement projects collectively entitled ``Improving the Impact of Laboratory Practice Guidelines: A New Paradigm for Metrics.'' An ``LPG'' is defined as written recommendations for voluntary, standardized approaches for medical laboratory testing that takes into account processes for test selection, sample procurement and processing, analytical methods, and results reporting for effective diagnosis and management of disease and health conditions. The overall purpose of these cooperative agreements is to increase the effectiveness of LPGs by defining measures and collecting information to inform better LPG creation, revision, dissemination, promotion, uptake, and impact on clinical testing and public health. The project will explore how these processes and their impediments and facilitators differ among various intended users of LPGs. Through this demonstration project, CDC seeks to understand how to customize LPG creation and promotion to better serve these intended users of LPGs. An important goal is to help organizations that sponsor the development of LPGs create a sustainable approach for continuous quality improvement to evaluate and improve an LPG's impact through better collection of information. One of the awardees is the College of American Pathologists (CAP). This revision request concerns additional information collection relating to the CAP's LPG for immunohistochemistry (IHC) testing, for which a post dissemination survey was approved under OMB Control No. 0920-1067 and has been completed. We are requesting a revision to the OMB-approved 0920-1067 package by adding two information collections: Telephone interviews and focus groups as a follow-up to the completed IHC LPG post survey to further explore the survey findings that are being analyzed now. The questions to be used for the telephone interviews and focus groups are based on the questions and results of the IHC post survey, to help CAP and CDC better understand the impediments and facilitators that affect uptake of the IHC LPG. The intended participants in the proposed telephone interviews and focus groups will be selected from the IHC post survey respondents which include pathologists, pathology chairs, clinical laboratory directors, laboratory managers overseeing the IHC staining department, laboratory supervisors, and histotechnologists. This revision request represents a decrease in burden. The proposed telephone interviews will explore the impediments and facilitators that affect uptake and use of the CAP IHC LPG, both generally and concerning specific recommendations. This will be followed by two focus groups, arranged into two peer groups of pathologists (composed of pathologists, pathology chairs, and laboratory directors) and non- pathologist laboratory professionals (composed of laboratory managers, laboratory supervisors, and histotechnologists for the purpose of estimating burden), which will allow us to collect information on the current usage of CAP's tools and resources (toolkit) to facilitate implementation of the IHC guideline for its future improvement. For this request, the CAP will collect information via 40 telephone interviews (20 pathologists, 10 laboratory directors, and 10 laboratory managers). The telephone interview questions are scripted to be completed within 20 minutes by each respondent (0.33 hour per respondent or ~13 hours total). Because the CAP anticipates that approximately 121 laboratory individuals (41 pathologists, 40 laboratory directors, and 40 laboratory managers) will need to be contacted to reach 40 individuals who will voluntarily participate, and the burden for those individuals who will not go on to participate (81) in the telephone interview is one minute, the total burden for individuals who decline participation is 81 minutes (1.35 hours). In addition, the CAP will conduct two focus group sessions and invite 12 participants to each of the sessions, composed of the following respondent types: (4) Pathologists, (4) pathology chairs, (4) laboratory directors, (4) laboratory managers, (4) laboratory supervisors, and (4) histotechnologists. Each of the focus groups will last no more than 60 minutes (1.0 hour) which is based on standard focus group planning instructions, inclusive of time required to complete informed consent (24 hours or 1,440 minutes total burden). It is anticipated that 200 individuals will be contacted to determine their availability to participate in one of the two focus group sessions and each will take no longer than 5 minutes to read and respond to the invitation letter (~17 hours or 1000 minutes total). The 200 individuals contacted will be composed of the following respondent types: (34) Pathologists, (33) pathology chairs, (33) laboratory directors, (34) laboratory managers, (33) laboratory supervisors, and (33) histotechnologists. This revision includes three types of laboratory professionals who were not included in the original OMB-approved submission: Pathology chairs, laboratory supervisors, and histotechnologists. Because the OMB-approved IHC post-survey has been completed, this request for approval of additional data collection (telephone interviews and focus groups) is a reduction of burden. The total new burden for this revision request will be ~58 hours which is a reduction of 1,512 hours from the previously approved submission. A total of 321 respondents (121 invited to take the telephone interview and 200 invited to participate in focus groups), is a reduction of 4,114 respondents with an approved burden of 1,570 hours and 4,435 respondents). There are no costs to respondents other than their time. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Form name Type of respondent Number of responses per per response respondents respondent (in hours) ---------------------------------------------------------------------------------------------------------------- IHC telephone interview-contacted..... Pathologists............ 41 1 1/60 Laboratory Directors.... 40 Laboratory Managers..... 40 IHC telephone interview............... Pathologists............ 20 1 20/60 Laboratory Directors.... 10 Laboratory Managers..... 10 IHC focus group invitation............ Pathologists............ 34 1 5/60 [[Page 23299]] Pathology Chairs........ 33 Laboratory Directors.... 33 Laboratory Managers..... 34 Laboratory Supervisors.. 33 Histotechnologists...... 33 IHC focus group....................... Pathologists............ 4 1 1 Pathology Chairs........ 4 Laboratory Directors.... 4 Laboratory Managers..... 4 Laboratory Supervisors.. 4 Histotechnologists...... 4 ---------------------------------------------------------------------------------------------------------------- LeRoy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2016-09190 Filed 4-19-16; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices 23297
the agreement, and revise the minimum CFR 225.41) to acquire shares of a bank DEPARTMENT OF HEALTH AND
level of service to be provided by the or bank holding company. The factors HUMAN SERVICES
agreement. that are considered in acting on the
Agreement No.: 011953–013. notices are set forth in paragraph 7 of Centers for Disease Control and
Title: Florida Shipowners Group the Act (12 U.S.C. 1817(j)(7)). Prevention
Agreement. The notices are available for
Parties: The member lines of the [30Day–16–1067]
immediate inspection at the Federal
Caribbean Shipowners Association and
Reserve Bank indicated. The notices Agency Forms Undergoing Paperwork
the Florida–Bahamas Shipowners and
also will be available for inspection at Reduction Act Review
Operators Association.
Filing Party: Wayne Rohde, Esq.; the offices of the Board of Governors.
Interested persons may express their The Centers for Disease Control and
Cozen O’Connor; 1200 Nineteenth Street Prevention (CDC) has submitted the
NW.; Washington, DC 20036. views in writing to the Reserve Bank
following information collection request
Synopsis: The amendment updates indicated for that notice or to the offices
to the Office of Management and Budget
Appendix A to update the membership of the Board of Governors. Comments
(OMB) for review and approval in
of the Caribbean Shipowners must be received not later than May 5,
accordance with the Paperwork
Association. 2016. Reduction Act of 1995. The notice for
Agreement No.: 012282–001. A. Federal Reserve Bank of Atlanta the proposed information collection is
Title: Kyowa Shipping Co., Ltd. and (Chapelle Davis, Assistant Vice published to obtain comments from the
Nippon Yusen Kaisha Space Charter President) 1000 Peachtree Street, NE., public and affected agencies.
Agreement. Atlanta, Georgia 30309. Comments can Written comments and suggestions
Parties: Kyowa Shipping Co., Ltd. and also be sent electronically to from the public and affected agencies
Nippon Yusen Kaisha. Applications.Comments@atl.frb.org: concerning the proposed collection of
Filing Party: Kristen Chung, Corporate information are encouraged. Your
Counsel, NYK Line (North America) 1. William Stuart Perry, Howard
comments should address any of the
Inc.; 300 Lighting Way, 5th Floor; Steven Perry, William Cavanagh Perry,
following: (a) Evaluate whether the
Secaucus, NJ 07094. Constance Ann Perry Thomas, Carrie
proposed collection of information is
Synopsis: The amendment adds the Peighton Perry VanAusdall, and necessary for the proper performance of
trade between American Samoa and Edmond Lewis Perry, all of Nashville, the functions of the agency, including
Japan to the geographic scope of the Georgia, Sara Amelia Perry Parkerson, whether the information will have
agreement. Greensboro, Georgia, and Justin Stuart practical utility; (b) Evaluate the
Agreement No.: 012399. Perry, Hilton Head, South Carolina; to accuracy of the agencies estimate of the
Title: NYK/Zim Slot Exchange retain voting shares of The Nashville burden of the proposed collection of
Agreement. Holding Company, and thereby information, including the validity of
Parties: Nippon Yusen Kaisha and indirectly retain voting shares of The the methodology and assumptions used;
Zim Integrated Shipping Services Co., Citizens Bank, both in Nashville, (c) Enhance the quality, utility, and
Ltd. Georgia. clarity of the information to be
Filing Party: Mark E. Newcomb; ZIM collected; (d) Minimize the burden of
B. Federal Reserve Bank of
American Integrated Shipping Services, the collection of information on those
Minneapolis (Jacquelyn K. Brunmeier,
Co. LLC; 5801 Lake Wright Dr.; Norfolk, who are to respond, including through
Assistant Vice President) 90 Hennepin
VA 23508. the use of appropriate automated,
Synopsis: The agreement authorizes Avenue, Minneapolis, Minnesota
55480–0291: electronic, mechanical, or other
the parties to charter slots on each technological collection techniques or
other’s vessels in the trade between the 1. Dean M. Wehri, as a trustee/ other forms of information technology,
U.S. on the one hand, and China, administrator of the Commercial Bank e.g., permitting electronic submission of
Vietnam, Singapore, Malaysia, of Mott Employee Stock Ownership responses; and (e) Assess information
Thailand, Sri Lanka, Egypt, Italy, United Plan and Trust, both of Mott, North collection costs.
Arab Emirates, and Canada on the other Dakota; to acquire voting shares of To request additional information on
hand. Commercial Bank of Mott Employee the proposed projects or to obtain a
By Order of the Federal Maritime Stock Ownership Plan and Trust, and copy of the information collection plan
Commission. thereby indirectly acquire voting shares and instruments, call (404) 639–7570 or
Dated: April 15, 2016. of Commercial Bank of Mott, both in send an email to omb@cdc.gov. Direct
Karen V. Gregory, Mott, North Dakota. written comments and/or suggestions
Secretary. Board of Governors of the Federal Reserve
regarding the items contained in this
[FR Doc. 2016–09146 Filed 4–19–16; 8:45 am] System, April 15, 2016.
notice to the Attention: CDC Desk
Officer, Office of Management and
BILLING CODE 6731–AA–P Margaret McCloskey Shanks, Budget, Washington, DC 20503 or by fax
Deputy Secretary of the Board. to (202) 395–5806. Written comments
[FR Doc. 2016–09124 Filed 4–19–16; 8:45 am] should be received within 30 days of
FEDERAL RESERVE SYSTEM
BILLING CODE 6210–01–P this notice.
Change in Bank Control Notices; Proposed Project
Lhorne on DSK5TPTVN1PROD with NOTICES
Acquisitions of Shares of a Bank or
Bank Holding Company Improving the Impact of Laboratory
Practice Guidelines (LPGs): A New
The notificants listed below have Paradigm for Metrics—College of
applied under the Change in Bank American Pathologists (OMB Control
Control Act (12 U.S.C. 1817(j)) and No. 0920–1067)—Revision—Center for
§ 225.41 of the Board’s Regulation Y (12 Surveillance, Epidemiology and
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ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Number of burden per
Form name Type of respondent responses per
respondents response
respondent (in hours)
Pathology Chairs ............................................ 33
Laboratory Directors ....................................... 33
Laboratory Managers ..................................... 34
Laboratory Supervisors .................................. 33
Histotechnologists .......................................... 33
IHC focus group .............................................. Pathologists .................................................... 4 1 1
Pathology Chairs ............................................ 4
Laboratory Directors ....................................... 4
Laboratory Managers ..................................... 4
Laboratory Supervisors .................................. 4
Histotechnologists .......................................... 4
LeRoy A. Richardson, administers 9-valent HPV (Human presented in understandable terms, and
Chief, Information Collection Review Office, Papillomavirus) Gardasil®-9 vaccine to include:
Office of Scientific Integrity, Office of the any child or adult in the United States (1) A concise description of the
Associate Director for Science, Office of the shall provide copies of the relevant benefits of the vaccine,
Director, Centers for Disease Control and vaccine information materials (2) A concise description of the risks
Prevention.
referenced in this notice, in associated with the vaccine,
[FR Doc. 2016–09190 Filed 4–19–16; 8:45 am] conformance with the March 31, 2016 (3) A statement of the availability of
BILLING CODE 4163–18–P CDC Instructions for the Use of Vaccine the National Vaccine Injury
Information Statements prior to Compensation Program, and
providing such vaccinations. (4) Such other relevant information as
DEPARTMENT OF HEALTH AND may be determined by the Secretary.
FOR FURTHER INFORMATION CONTACT:
HUMAN SERVICES The vaccines initially covered under
Suzanne Johnson-DeLeon (msj1@
Centers for Disease Control and cdc.gov), National Center for the National Vaccine Injury
Prevention Immunization and Respiratory Diseases, Compensation Program were diphtheria,
Centers for Disease Control and tetanus, pertussis, measles, mumps,
[Docket No. CDC–2015–0089] Prevention, Mailstop A–19, 1600 Clifton rubella, and poliomyelitis vaccines.
Road NE., Atlanta, Georgia 30329. Since April 15, 1992, any health care
Final Revised Vaccine Information provider in the United States who
SUPPLEMENTARY INFORMATION: The
Materials for 9-valent HPV (Human intends to administer one of these
Papillomavirus) Vaccine National Childhood Vaccine Injury Act
of 1986 (Pub. L. 99–660), as amended by covered vaccines is required to provide
AGENCY: Centers for Disease Control and section 708 of Public Law 103–183, copies of the relevant vaccine
Prevention (CDC), Department of Health added section 2126 to the Public Health information materials prior to
and Human Services (HHS). Service Act. Section 2126, codified at 42 administration of any of these vaccines.
ACTION: Notice. U.S.C. 300aa–26, requires the Secretary Since then, the following vaccines have
of Health and Human Services to been added to the National Vaccine
SUMMARY: Under the National develop and disseminate vaccine Injury Compensation Program, requiring
Childhood Vaccine Injury Act information materials for distribution by use of vaccine information materials for
(NCVIA)(42 U.S.C. 300aa–26), CDC must all health care providers in the United them as well: Hepatitis B, Haemophilus
develop vaccine information materials States to any patient (or to the parent or influenzae type b (Hib), varicella
that all health care providers are legal representative in the case of a (chickenpox), pneumococcal conjugate,
required to give to patients/parents prior child) receiving vaccines covered under rotavirus, hepatitis A, meningococcal,
to administration of specific vaccines. the National Vaccine Injury human papillomavirus (HPV), and
On October 22, 2015, CDC published a Compensation Program (VICP). seasonal influenza vaccines.
notice in the Federal Register (80 FR Development and revision of the Instructions for use of the vaccine
64002) seeking public comments on vaccine information materials, also information materials are found on the
proposed updated vaccine information known as Vaccine Information CDC Web site at: http://www.cdc.gov/
materials for 9-valent HPV (Human Statements (VIS), have been delegated vaccines/hcp/vis/index.html.
Papillomavirus) Gardasil®-9 vaccine. by the Secretary to the Centers for
Following review of comments Disease Control and Prevention (CDC). Revised Vaccine Information Materials
submitted and consultation as required Section 2126 requires that the materials The 9-valent HPV (Human
under the law, CDC has finalized the be developed, or revised, after notice to Papillomavirus) Gardasil®-9 vaccine
materials. Copies of the final vaccine the public, with a 60-day comment information materials referenced in this
information materials for 9-valent HPV period, and in consultation with the notice were developed in consultation
Lhorne on DSK5TPTVN1PROD with NOTICES
Gardasil®-9 vaccine are available to Advisory Commission on Childhood with the Advisory Commission on
download from http://www.cdc.gov/ Vaccines, appropriate health care Childhood Vaccines, the Food and Drug
vaccines/hcp/vis/index.html or http:// provider and parent organizations, and Administration, and parent and
www.regulations.gov (see Docket the Food and Drug Administration. The healthcare provider organizations.
Number CDC–2015–0089). law also requires that the information Following consultation and review of
DATES: Beginning no later than July 1, contained in the materials be based on comments submitted, the vaccine
2016, each health care provider who available data and information, be information materials covering 9-valent
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Document Created: 2016-04-20 01:51:53
Document Modified: 2016-04-20 01:51:53
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