81 FR 5127 - Proposed Data Collections Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 20 (February 1, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 20 (February 1, 2016)
| Page Range | 5127-5129 | |
| FR Document | 2016-01722 |
[Federal Register Volume 81, Number 20 (Monday, February 1, 2016)] [Notices] [Pages 5127-5129] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01722] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60 Day-16-0017; Docket No. CDC-2016-0014] Proposed Data Collections Submitted for Public Comment and Recommendations AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. ----------------------------------------------------------------------- SUMMARY: The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on proposed revisions of the information collection entitled Application for Training (OMB Control No. 0920-0017). CDC seeks to request Office of Management and Budget approval to (1) continue to collect information through the use of the Training and Continuing Education Online New Participant Registration form for new learners to establish an account that provides CDC necessary information to process learner requests for continuing education, and (2) implement a new electronic information collection through the use of the Training and Continuing Education Online Proposal form that allows training developers to provide CDC necessary information to process and accredit trainings for continuing education. DATES: Written comments must be received on or before April 1, 2016. ADDRESSES: You may submit comments, identified by Docket No. CDC-2016- 0014 by any of the following methods: Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments. Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS- D74, 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 Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov. Please note: All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above. FOR FURTHER INFORMATION CONTACT: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639- 7570. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. Comments are invited 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) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the [[Page 5128]] burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. Proposed Project Application for Training (OMB Control No. 0920-0017, Expiration 05/ 31/2016)--Revision--Division of Scientific Education and Professional Development (DSEPD), Center for Surveillance, Epidemiology and Laboratory Services (CSELS), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC offers public health training to professionals worldwide. Employees of hospitals, universities, medical centers, state and local health departments, and federal agencies apply for training to learn up-to-date public health and healthcare practices. CDC is accredited by multiple accreditation organizations to award continuing education (CE) for public health and healthcare professions. CDC requires health professionals seeking continuing education (learners) to use the Training and Continuing Education Online (TCEO) system to establish an account by completing the TCEO New Participant Registration form. CDC/CSELS relies on this form to collect information needed to coordinate learner registration for training activities including classroom study, conferences, and e-learning. The TCEO Proposal is a form course developers will use the TCEO system to apply for their training activities to receive continuing education accreditation through CDC. Introduction of this mechanism will allow course developers to electronically complete and submit continuing education proposals. CDC requests OMB approval to (1) continue to collect information through the TCEO New Participant Registration form to grant public health professionals the continuing education they need to maintain professional licenses and certifications, create a transcript or summary of training at the participant's request, generate management reports, and maintain training statistics; and (2) establish a new electronic information collection that allows CDC or CDC partner course developers to electronically submit training and continuing education proposals for accreditation. CDC's TCEO system provides an efficient and effective way for CDC to comply with accreditation organization requirements. Accreditation organizations require a method of tracking participants who complete an education activity and several require collection of profession- specific data. Some accrediting organizations require a permanent record that includes the participant's name, address, and phone number to facilitate retrieval of historical information about when a participant completed a course or several courses during a time period. These data provide the basis for a transcript or for determining whether a person is enrolled in more than one course. CDC uses the email address to verify the participant's electronic request for transcripts, verify course certificates, and send confirmation that a participant is registered for a course. Collection of demographic and profession-specific data through the TCEO New Participant Registration allows CDC to comply with accreditation organization requirements. The TCEO Proposal will expedite submission, review, and accreditation processes and provide CDC with the information necessary to meet accreditation organization requirements, accredit, and effectively manage training activities. Examples of data to be collected for CDC to process continuing education proposals and meet accreditation organization requirements includes name, email address, phone number, and organization name. These forms do not duplicate request for information from participants or course developers. Data are collected only once per new registration or once per course. These information collection instruments have provided, and will continue to provide CDC with the information necessary to manage and conduct training activities pertinent to its mission to strengthen the skills of the current workforce through quality, accredited, competency-based training. The annual burden table has been updated to reflect (1) discontinuance of the National Laboratory Training Network Registration form, (2) an increase in learners seeking continuing education, particularly through e-learning activities (16,667 burden hours), (3) the introduction of the new TCEO Proposal (600 burden hours), for a total of 17,267 burden hours. There are no costs to respondents. Estimated Annualized Burden Hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Total burden Type of respondent Form name respondents responses per response (in (in hours) respondent hours) -------------------------------------------------------------------------------------------------------------------------------------------------------- Health Professionals........................... Training and Continuing Education 200,000 1 5/60 16,667 Online New Participant Registration Form. Health Educators............................... Training and Continuing Education 120 1 5 600 Online. --------------------------------------------------------------- Total...................................... ....................................... .............. .............. .............. 17,267 -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 5129]] 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. 2016-01722 Filed 1-29-16; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 81, No. 20 / Monday, February 1, 2016 / Notices 5127
consider making it available as a printed diagnosis of SLE will be conducted to prototype CDC SLE Self-management
resource, depending on the feedback assess the tool. The same discussion Tool in advance of the focus group
obtained during the testing process. guide will be used for all information meeting or telephone interview.
The information collection will also collections. OMB approval is requested for one
gauge the needs of the target The estimated burden per response
year. Participation is voluntary and
audience(s), tool format and delivery for participating in a focus group
method(s), and the tool’s clarity, discussion is two hours. The estimated there are no costs to respondents other
relevance, salience and appeal. A series burden per response for a discussion than their time.
of focus groups with women with a conducted via telephone interview is 45 The total estimated burden hours are
diagnosis of SLE, and one-on-one minutes. Respondent burden also 646.
telephone interviews with men with a includes two hours for reviewing the
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average
Number of responses burden per
Type of respondents Form name respondents per response
respondent (in hrs.)
Women with SLE diagnosis .... Screener for Women .............................................................. 192 1 10/60
Prototype CDC SLE Self-management Tool ......................... 128 1 2
Discussion Guide for Use in Focus Groups with Women or 128 1 2
Interviews with Men.
Men with SLE diagnosis ......... Screener for Men ................................................................... 40 1 10/60
Prototype CDC SLE Self-management Tool ......................... 20 2 2
Discussion Guide for Use in Focus Groups with Women or 20 1 45/60
Interviews with Men.
Leroy A. Richardson, Office of Management and Budget Please note: All public comment should be
Chief, Information Collection Review Office, approval to (1) continue to collect submitted through the Federal eRulemaking
Office of Scientific Integrity Office of the information through the use of the portal (Regulations.gov) or by U.S. mail to the
Associate Director for Science, Office of the address listed above.
Training and Continuing Education
Director, Centers for Disease Control and Online New Participant Registration FOR FURTHER INFORMATION CONTACT:
Prevention. form for new learners to establish an Leroy A. Richardson, Information
[FR Doc. 2016–01720 Filed 1–29–16; 8:45 am] account that provides CDC necessary Collection Review Office, Centers for
BILLING CODE 4163–18–P information to process learner requests Disease Control and Prevention, 1600
for continuing education, and (2) Clifton Road NE., MS–D74, Atlanta,
implement a new electronic information Georgia 30329; phone: 404–639–7570.
DEPARTMENT OF HEALTH AND collection through the use of the SUPPLEMENTARY INFORMATION: Under the
HUMAN SERVICES Training and Continuing Education Paperwork Reduction Act of 1995 (PRA)
Centers for Disease Control and Online Proposal form that allows (44 U.S.C. 3501–3520), Federal agencies
Prevention training developers to provide CDC must obtain approval from the Office of
necessary information to process and Management and Budget (OMB) for each
[60 Day–16–0017; Docket No. CDC–2016– accredit trainings for continuing collection of information they conduct
0014] education. or sponsor. In addition, the PRA also
requires Federal agencies to provide a
Proposed Data Collections Submitted DATES: Written comments must be 60-day notice in the Federal Register
for Public Comment and received on or before April 1, 2016. concerning each proposed collection of
Recommendations
ADDRESSES: You may submit comments, information, including each new
AGENCY: Centers for Disease Control and identified by Docket No. CDC–2016– proposed collection, each proposed
Prevention (CDC), Department of Health 0014 by any of the following methods: extension of existing collection of
and Human Services (HHS). Federal eRulemaking Portal: information, and each reinstatement of
ACTION: Notice with comment period. Regulations.gov. Follow the instructions previously approved information
for submitting comments. collection before submitting the
SUMMARY: The Centers for Disease collection to OMB for approval. To
Control and Prevention (CDC), as part of Mail: Leroy A. Richardson, comply with this requirement, we are
its continuing efforts to reduce public Information Collection Review Office, publishing this notice of a proposed
burden and maximize the utility of Centers for Disease Control and data collection as described below.
government information, invites the Prevention, 1600 Clifton Road NE., MS– Comments are invited on: (a) Whether
general public and other Federal D74, Atlanta, Georgia 30329. the proposed collection of information
agencies to take this opportunity to Instructions: All submissions received is necessary for the proper performance
comment on proposed and/or must include the agency name and of the functions of the agency, including
rmajette on DSK2TPTVN1PROD with NOTICES
continuing information collections, as Docket Number. All relevant comments whether the information shall have
required by the Paperwork Reduction received will be posted without change practical utility; (b) the accuracy of the
Act of 1995. This notice invites to Regulations.gov, including any agency’s estimate of the burden of the
comment on proposed revisions of the personal information provided. For proposed collection of information; (c)
information collection entitled access to the docket to read background ways to enhance the quality, utility, and
Application for Training (OMB Control documents or comments received, go to clarity of the information to be
No. 0920–0017). CDC seeks to request Regulations.gov. collected; (d) ways to minimize the
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![Federal Register / Vol. 81, No. 20 / Monday, February 1, 2016 / Notices 5129
Leroy A. Richardson, appropriate advisory committee meeting at least 7 days in advance of the
Chief, Information Collection Review Office, link, or call the advisory committee meeting.
Office of Scientific Integrity, Office of the information line to learn about possible FDA is committed to the orderly
Associate Director for Science, Office of the modifications before coming to the conduct of its advisory committee
Director, Centers for Disease Control and meeting. meetings. Please visit our Web site at
Prevention. Agenda: The committee will discuss http://www.fda.gov/
[FR Doc. 2016–01722 Filed 1–29–16; 8:45 am] the specific risk-benefit profile for new AdvisoryCommittees/
BILLING CODE 4163–18–P drug application (NDA) 207318, AboutAdvisoryCommittees/
NUPLAZID (pimavanserin) 17 milligram ucm111462.htm for procedures on
(mg) immediate-release, film-coated oral public conduct during advisory
DEPARTMENT OF HEALTH AND tablets, submitted by Acadia committee meetings.
HUMAN SERVICES Pharmaceuticals Inc., for the proposed Notice of this meeting is given under
treatment of psychosis associated with the Federal Advisory Committee Act (5
Food and Drug Administration Parkinson’s disease. U.S.C. app. 2).
[Docket No. FDA–2016–N–0001] FDA intends to make background
Dated: January 27, 2016.
material available to the public no later
Psychopharmacologic Drugs Advisory than 2 business days before the meeting. Jill Hartzler Warner,
Committee; Notice of Meeting If FDA is unable to post the background Associate Commissioner for Special Medical
material on its Web site prior to the Programs.
AGENCY: Food and Drug Administration, meeting, the background material will [FR Doc. 2016–01752 Filed 1–29–16; 8:45 am]
HHS. be made publicly available at the BILLING CODE 4164–01–P
ACTION: Notice. location of the advisory committee
meeting, and the background material
This notice announces a forthcoming will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND
meeting of a public advisory committee the meeting. Background material is HUMAN SERVICES
of the Food and Drug Administration available at http://www.fda.gov/
(FDA). The meeting will be open to the Office of the Secretary
AdvisoryCommittees/Calendar/
public. default.htm. Scroll down to the [Document Identifier: HHS–OS–0990–XXXX–
Name of Committee: appropriate advisory committee meeting 60D]
Psychopharmacologic Drugs Advisory link.
Committee. Procedure: Interested persons may Agency Information Collection
General Function of the Committee: present data, information, or views, Activities; Proposed Collection; Public
To provide advice and orally or in writing, on issues pending Comment Request
recommendations to the Agency on before the committee. Written
FDA’s regulatory issues. AGENCY: Office of the Secretary, HHS.
submissions may be made to the contact
Date and Time: The meeting will be ACTION: Notice.
person on or before March 15, 2016.
held on March 29, 2016, from 8 a.m. to Oral presentations from the public will SUMMARY: In compliance with section
5 p.m. be scheduled between approximately 1 3506(c)(2)(A) of the Paperwork
Location: FDA White Oak Campus, p.m. and 2 p.m. Those individuals Reduction Act of 1995, the Office of the
10903 New Hampshire Ave., Bldg. 31 interested in making formal oral Secretary (OS), Department of Health
Conference Center, the Great Room (Rm. presentations should notify the contact and Human Services, announces plans
1503), Silver Spring, MD 20993–0002. person and submit a brief statement of to submit a new Information Collection
Answers to commonly asked questions the general nature of the evidence or Request (ICR), described below, to the
including information regarding special arguments they wish to present, the Office of Management and Budget
accommodations due to a disability, names and addresses of proposed (OMB). Prior to submitting the ICR to
visitor parking, and transportation may participants, and an indication of the OMB, OS seeks comments from the
be accessed at: http://www.fda.gov/ approximate time requested to make public regarding the burden estimate,
AdvisoryCommittees/ their presentation on or before March 7, below, or any other aspect of the ICR.
AboutAdvisoryCommittees/ 2016. Time allotted for each DATES: Comments on the ICR must be
ucm408555.htm. presentation may be limited. If the
Contact Person: Kalyani Bhatt, Center received on or before April 1, 2016.
number of registrants requesting to
for Drug Evaluation and Research, Food ADDRESSES: Submit your comments to
speak is greater than can be reasonably
and Drug Administration, 10903 New accommodated during the scheduled Information.CollectionClearance@
Hampshire Ave., Bldg. 31, Rm. 2417, open public hearing session, FDA may hhs.gov or by calling (202) 690–6162.
Silver Spring, MD 20993–0002, 301– conduct a lottery to determine the FOR FURTHER INFORMATION CONTACT:
796–9001, FAX: 301–847–8533, PDAC@ speakers for the scheduled open public Information Collection Clearance staff,
fda.hhs.gov, or FDA Advisory hearing session. The contact person will Information.CollectionClearance@
Committee Information Line, 1–800– notify interested persons regarding their hhs.gov or (202) 690–6162.
741–8138 (301–443–0572 in the request to speak by March 8, 2016. SUPPLEMENTARY INFORMATION: When
Washington, DC area). A notice in the Persons attending FDA’s advisory submitting comments or requesting
Federal Register about last minute committee meetings are advised that the information, please include the
modifications that impact a previously Agency is not responsible for providing document identifier HHS–OS–0990–
rmajette on DSK2TPTVN1PROD with NOTICES
announced advisory committee meeting access to electrical outlets. XXXX–60D for reference.
cannot always be published quickly FDA welcomes the attendance of the Information Collection Request Title:
enough to provide timely notice. public at its advisory committee Surgeon General’s Pledge to Stem the
Therefore, you should always check the meetings and will make every effort to Opioid Epidemic
Agency’s Web site at http:// accommodate persons with disabilities. Abstract: The Office of the Surgeon
www.fda.gov/AdvisoryCommittees/ If you require accommodations due to a General, Office of the Secretary,
default.htm and scroll down to the disability, please contact Kalyani Bhatt Department of Health and Human
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Document Created: 2016-01-30 01:17:11
Document Modified: 2016-01-30 01:17:11
| 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 | |
| Action | Notice with comment period. | |
| Dates | Written comments must be received on or before April 1, 2016. | |
| Contact | Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639- 7570. | |
| FR Citation | 81 FR 5127 |
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