80 FR 71804 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 221 (November 17, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 221 (November 17, 2015)
| Page Range | 71804-71806 | |
| FR Document | 2015-29273 |
[Federal Register Volume 80, Number 221 (Tuesday, November 17, 2015)] [Notices] [Pages 71804-71806] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-29273] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-16-0964] 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 project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to omb@cdc.gov. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or [[Page 71805]] by fax to (202) 395-5806. Written comments should be received within 30 days of this notice. Proposed Project Interventions to Reduce Shoulder MSDS in Overhead Assembly (OMB No. 0920-0964 Exp. 04/30/2015)--Reinstatement--National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background and Brief Description The mission of the National Institute for Occupational Safety and Health (NIOSH) is to promote safety and health at work for all people through research and prevention. Under Public Law 91- 596, sections 20 and 22 (Section 20-22, Occupational Safety and Health Act of 1970), NIOSH has the responsibility to conduct research to advance the health and safety of workers. In this capacity, NIOSH proposes to conduct a study to assess the effectiveness and cost-benefit of occupational safety and health (OSH) interventions to prevent musculoskeletal disorders (MSDs) among workers in the Manufacturing (MNF) sector. A reinstatement is necessary because there were significant delays in implementing the tooling intervention in the intended work processes. These delays were to a large degree due to business conditions and were outside of the control of investigators. As result, the study achieved approximately 50% of the original sample size approved by OMB in the original ICR request. The reinstatement is necessary to extend the duration of the ICR so that the additional participants can enrolled and data collection can continue. The U.S. Manufacturing sector has faced a number of challenges including an overall decline in jobs, an aging workforce, and changes in organizational management systems. Studies have indicated that the average age of industrial workers is increasing and that older workers may differ from younger workers in work capacity, injury risk, severity of injuries, and speed of recovery (Kenny et al., 2008; Gall et al., 2004; Restrepo et al., 2006). As the average age of the industrial population increases and newer systems of work organization (such as lean manufacturing) are changing the nature of labor-intensive work, prevention of MSDs will be more critical to protecting older workers and maintaining productivity. This study will evaluate the efficacy of two intervention strategies for reducing musculoskeletal symptoms and pain in the shoulder attributable to overhead assembly work in automotive manufacturing. These interventions are, (1) an articulating spring- tensioned tool support device that unloads from the worker the weight of the tool that would otherwise be manually supported, and, (2) a targeted exercise program intended to increase individual employees' strength and endurance in the shoulder and upper arm stabilizing muscle group. As a primary prevention strategy, the tool support engineering control approach is preferred; however, a cost-efficient opportunity exists to concurrently evaluate the efficacy of a preventive exercise program intervention. Both of these intervention approaches have been used in the Manufacturing sector, and preliminary evidence suggests that both approaches may have merit. However, high quality evidence demonstrating their effectiveness, by way of controlled trials, is lacking. This project will be conducted as a partnership between NIOSH and Toyota Motors Engineering & Manufacturing North America, Inc. (TEMA), with the intervention evaluation study taking place at the Toyota Motor Manufacturing Kentucky, Inc. (TMMK) manufacturing facility in Georgetown, Kentucky. The prospective intervention evaluation study will be conducted using a group-randomized controlled trial multi-time series design. Four groups of 25-30 employees will be established to test the two intervention treatment conditions (tool support, exercise program), a combined intervention treatment condition, and a control condition. The four groups will be comprised of employees working on two vehicle assembly lines in different parts of the facility, on two work shifts (first and second shift). Individual randomization to treatment condition is not feasible, so a group-randomization (by work unit) will be used to assign the four groups to treatment and control conditions. Observations will be made over the 24-month study period and questionnaires will include the Shoulder Rating Questionnaire (SRQ), Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, a Standardized Nordic Questionnaire for body part discomfort, and a Work Organization Questionnaire. In addition to the questionnaires a shoulder-specific functional capacity evaluation test battery will be administered at 90 and 210 days, immediately pre- and post- intervention, to confirm the efficacy of the targeted exercise program in improving shoulder capacity. In summary, this study will evaluate the effectiveness of two interventions to reduce musculoskeletal symptoms and pain in the shoulder associated with repetitive overhead work in the manufacturing industry and the associated research project will disseminate the results of evidence-based prevention practices to the greatest audience possible. There is no cost to respondents other than their time. The estimated annualized burden is 236 hours. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondents Form name Number of responses per per response respondents respondent (in hours) ---------------------------------------------------------------------------------------------------------------- Employees Informed Consent Form... 63 1 5/60 Consent of Photographic 63 1 2/60 Image Release. Physical Activity 63 1 2/60 Readiness (PAR-Q). Shoulder Rating 63 10 4/60 Questionnaire. Disabilities of Arm 63 10 6/10 Shoulder and Hand Dash (DASH). Standardized Nordic 63 10 4/60 Questionnaire for Musculoskeletal Symptom Instruments. Work Organization 63 3 26/60 Questionnaire. ---------------------------------------------------------------------------------------------------------------- [[Page 71806]] 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. 2015-29273 Filed 11-16-15; 8:45 am] BILLING CODE 4163-18-P
![71804 Federal Register / Vol. 80, No. 221 / Tuesday, November 17, 2015 / Notices
Section C–B, Organization and pandemic influenza preparedness and Centers for Disease Control and
Functions, is hereby amended as response from strategy through Prevention and the Agency for Toxic
follows: implementation and evaluation. In Substances and Disease Registry.
Delete in its entirety the title and carrying out its mission, the ICU: (1)
function statements for the Influenza Elaine L. Baker,
Serves as the principal advisor to the
Coordination Unit (CVA4). CDC Director on pandemic influenza Director, Management Analysis and Services
Delete in its entirety the title and Office, Centers for Disease Control and
preparedness and response activities,
function statements for the National Prevention.
assisting the Director in formulating and
Center for Immunization and [FR Doc. 2015–29258 Filed 11–16–15; 8:45 am]
communicating strategic pandemic
Respiratory Diseases (CVG) and insert initiatives and policies; (2) provides BILLING CODE 4163–18–P
the following: strategic leadership for CDC in the areas
National Center for Immunization of pandemic preparedness and
and Respiratory Diseases (CVG). The response, including setting priorities DEPARTMENT OF HEALTH AND
National Center for Immunization and and promoting science, policies, and HUMAN SERVICES
Respiratory Diseases (NCIRD) prevents programs related to pandemic influenza;
disease, disability, and death through Centers for Disease Control and
(3) strategically manages a budget and Prevention
immunization and by control of allocates funds across the agency to
respiratory and related diseases. In ensure appropriate resources for high [30Day–16–0964]
carrying out its mission, NCIRD: (1) priority areas; and (4) conducts ongoing
Provides leadership, expertise, and evaluation and adjustment of pandemic Agency Forms Undergoing Paperwork
service in laboratory and preparedness and response activities, in Reduction Act Review
epidemiological sciences, and in coordination with the National
immunization program delivery; (2) The Centers for Disease Control and
Response Framework and other Prevention (CDC) has submitted the
conducts applied research on disease emergency preparedness guidance, to
prevention and control; (3) translates following information collection request
ensure optimal public health to the Office of Management and Budget
research findings into public health effectiveness and efficient use of human
policies and practices; (4) provides (OMB) for review and approval in
and fiscal resources by developing and accordance with the Paperwork
diagnostic and reference laboratory leading an exercise program for the
services to relevant partners; (5) Reduction Act of 1995. The notice for
Agency, in collaboration with HHS and the proposed information collection is
conducts surveillance and research to other partners.
determine disease distribution, published to obtain comments from the
determinants, and burden nationally James Seligman, public and affected agencies.
and internationally; (6) responds to Acting Chief Operating Officer, Centers for Written comments and suggestions
disease outbreaks domestically and Disease Control and Prevention. from the public and affected agencies
abroad; (7) ensures that public health [FR Doc. 2015–29276 Filed 11–16–15; 8:45 am] concerning the proposed collection of
decisions are made objectively and BILLING CODE 4160–18–P information are encouraged. Your
based upon the highest quality of comments should address any of the
scientific data; (8) provides technical following: (a) Evaluate whether the
expertise, education, and training to DEPARTMENT OF HEALTH AND proposed collection of information is
domestic and international partners; (9) HUMAN SERVICES necessary for the proper performance of
provides leadership to internal and the functions of the agency, including
external partners for establishing and Centers for Disease Control and whether the information will have
maintaining immunization, and other Prevention practical utility; (b) Evaluate the
prevention and control programs; (10) accuracy of the agencies estimate of the
Board of Scientific Counselors, Office burden of the proposed collection of
develops, implements, and evaluates
of Infectious Diseases: Notice of information, including the validity of
domestic and international public
Charter Renewal the methodology and assumptions used;
health policies; (11) communicates
information to increase awareness, This gives notice under the Federal (c) Enhance the quality, utility, and
knowledge, and understanding of public Advisory Committee Act (Pub. L. 92– clarity of the information to be
health issues domestically and 463) of October 6, 1972, that the Board collected; (d) Minimize the burden of
internationally, and to promote effective of Scientific Counselors, Office of the collection of information on those
immunization programs; (12) aligns the Infectious Diseases, Centers for Disease who are to respond, including through
national center focus with the overall Control and Prevention (CDC), the use of appropriate automated,
strategic goals of CDC; (13) synchronizes Department of Health and Human electronic, mechanical, or other
all aspects of CDC’s pandemic influenza Services (HHS), has been renewed for a technological collection techniques or
preparedness and response from 2-year period through October 31, 2017. other forms of information technology,
strategy through implementation and For information, contact Robin e.g., permitting electronic submission of
evaluation; and (14) implements, Moseley, M.A.T., Designated Federal responses; and (e) Assess information
coordinates, and evaluates programs Officer, Board of Scientific Counselors, collection costs.
across NCIRD, Office of Infectious Office of Infectious Diseases, CDC, HHS, To request additional information on
Diseases (OID), and CDC to optimize 1600 Clifton Road NE., Mailstop D10, the proposed project or to obtain a copy
mstockstill on DSK4VPTVN1PROD with NOTICES
public health impact. Atlanta, Georgia 30329–4027, telephone of the information collection plan and
After the Office of Science and 404/639–4461 or fax 404/235–3562. instruments, call (404) 639–7570 or
Integrated Programs (CVG17) insert the The Director, Management Analysis send an email to omb@cdc.gov. Written
following: and Services Office, has been delegated comments and/or suggestions regarding
Influenza Coordination Unit (CVG18). the authority to sign Federal Register the items contained in this notice
The mission of the Influenza notices pertaining to announcements of should be directed to the Attention:
Coordination Unit (ICU) is to meetings and other committee CDC Desk Officer, Office of Management
synchronize all aspects of CDC’s management activities, for both the and Budget, Washington, DC 20503 or
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![71806 Federal Register / Vol. 80, No. 221 / Tuesday, November 17, 2015 / Notices
Leroy A. Richardson, personal information provided. For maintaining information, and disclosing
Chief, Information Collection Review Office, access to the docket to read background and providing information; to train
Office of Scientific Integrity, Office of the documents or comments received, go to personnel and to be able to respond to
Associate Director for Science, Office of the Regulations.gov. a collection of information, to search
Director, Centers for Disease Control and Please note: All public comment data sources, to complete and review
Prevention. should be submitted through the the collection of information; and to
[FR Doc. 2015–29273 Filed 11–16–15; 8:45 am] Federal eRulemaking portal transmit or otherwise disclose the
BILLING CODE 4163–18–P (Regulations.gov) or by U.S. mail to the information.
address listed above.
Proposed Project
FOR FURTHER INFORMATION CONTACT: To
DEPARTMENT OF HEALTH AND Integrating Community Pharmacists
request more information on the
HUMAN SERVICES and Clinical Sites for Patient-Centered
proposed project or to obtain a copy of
the information collection plan and HIV Care (OMB 0920–1019, expires 8/
Centers for Disease Control and 31/2018)—Revision—National Center
Prevention instruments, contact the Information
Collection Review Office, Centers for for HIV/AIDS, Viral Hepatitis, STD, and
[60Day–16–1019; Docket No. CDC–2015– Disease Control and Prevention, 1600 TB Prevention (NCHHSTP), Centers for
0102] Clifton Road NE., MS–D74, Atlanta, Disease Control and Prevention (CDC).
Georgia 30329; phone: 404–639–7570; Background and Brief Description
Proposed Data Collection Submitted
Email: omb@cdc.gov. Medication Therapy Management
for Public Comment and
Recommendations SUPPLEMENTARY INFORMATION: Under the (MTM) is a group of pharmacist
Paperwork Reduction Act of 1995 (PRA) provided services that is independent
AGENCY: Centers for Disease Control and (44 U.S.C. 3501–3520), Federal agencies of, but can occur in conjunction with,
Prevention (CDC), Department of Health must obtain approval from the Office of provision of medication. Medication
and Human Services (HHS). Management and Budget (OMB) for each Therapy Management encompasses a
ACTION: Notice with comment period. collection of information they conduct broad range of professional activities
or sponsor. In addition, the PRA also and cognitive services within the
SUMMARY: The Centers for Disease requires Federal agencies to provide a licensed pharmacists’ scope of practice
Control and Prevention (CDC), as part of 60-day notice in the Federal Register and can include monitoring prescription
its continuing efforts to reduce public concerning each proposed collection of filling patterns and timing of refills,
burden and maximize the utility of information, including each new checking for medication interactions,
government information, invites the proposed collection, each proposed patient education, and monitoring of
general public and other Federal extension of existing collection of patient response to drug therapy.
agencies to take this opportunity to information, and each reinstatement of HIV-specific MTM programs have
comment on proposed and/or previously approved information demonstrated success in improving HIV
continuing information collections, as collection before submitting the medication therapy adherence and
required by the Paperwork Reduction collection to OMB for approval. To persistence. While MTM programs have
Act of 1995. comply with this requirement, we are be shown to be effective in increasing
This notice invites comment on publishing this notice of a proposed medication adherence for HIV-infected
Integrating Community Pharmacists and data collection as described below. persons, no MTM programs have been
Clinical Sites for Patient-Centered HIV Comments are invited on: (a) Whether expanded to incorporate primary
Care. CDC is requesting a 3-year the proposed collection of information medical providers in an effort to
approval for revision to the previously is necessary for the proper performance establish patient-centered HIV care. To
approved project to administer a staff of the functions of the agency, including address this problem, CDC has entered
communication questionnaire for whether the information shall have into a public-private partnership with
medical providers in order to determine practical utility; (b) the accuracy of the Walgreen Company (a.k.a. Walgreens
how and if the model program improves agency’s estimate of the burden of the pharmacies, a national retail pharmacy
patient outcomes through improved proposed collection of information; (c) chain) to develop and implement a
communication and collaboration ways to enhance the quality, utility, and model of HIV care that integrates
between patients’ clinical providers and clarity of the information to be community pharmacists with primary
pharmacists. collected; (d) ways to minimize the medical providers for patient-centered
DATES: Written comments must be burden of the collection of information HIV care. The model program will be
received on or before January 19, 2016. on respondents, including through the implemented in ten sites and will
ADDRESSES: You may submit comments, use of automated collection techniques provide patient-centered HIV care for
identified by Docket No. CDC–2015– or other forms of information approximately 1,000 persons.
0102 by any of the following methods: technology; and (e) estimates of capital The patient-centered HIV care model
• Federal eRulemaking Portal: or start-up costs and costs of operation, will include the core elements of MTM
Regulation.gov. Follow the instructions maintenance, and purchase of services as well as additional services such as
for submitting comments. to provide information. Burden means individualized medication adherence
• Mail: Leroy A. Richardson, the total time, effort, or financial counseling, active monitoring of
Information Collection Review Office, resources expended by persons to prescription refills and active
mstockstill on DSK4VPTVN1PROD with NOTICES
Centers for Disease Control and generate, maintain, retain, disclose or collaboration between pharmacists and
Prevention, 1600 Clifton Road NE., MS– provide information to or for a Federal medical clinic providers to identify and
D74, Atlanta, Georgia 30329. agency. This includes the time needed resolve medication related treatment
Instructions: All submissions received to review instructions; to develop, problems such as treatment
must include the agency name and acquire, install and utilize technology effectiveness, adverse events and poor
Docket Number. All relevant comments and systems for the purpose of adherence. The expected outcomes of
received will be posted without change collecting, validating and verifying the model program are increased
to Regulations.gov, including any information, processing and retention in HIV care, adherence to HIV
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Document Created: 2015-12-14 14:00:15
Document Modified: 2015-12-14 14:00:15
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 80 FR 71804 |
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