Proposed Data Collections Submitted for Public Comment and Recommendations, 15345-15347 [2014-05946]

Download as PDF Federal Register / Vol. 79, No. 53 / Wednesday, March 19, 2014 / Notices HHS Web site: http:// www.pso.AHRQ.gov/index.html. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: Agency for Healthcare Research and Quality Eileen Hogan, Center for Quality Improvement and Patient Safety, AHRQ, 540 Gaither Road, Rockville, MD 20850; Telephone (toll free): (866) 403–3697; Telephone (local): (301) 427–1111; TTY (toll free): (866) 438–7231; TTY (local): (301) 427–1130; Email: pso@ AHRQ.hhs.gov. Patient Safety Organizations: Voluntary Relinquishment From WiMED, Inc. SUPPLEMENTARY INFORMATION: Agency for Healthcare Research and Quality (AHRQ), Department of Health and Human Services (HHS). ACTION: Notice of Delisting. Background SUMMARY: The Patient Safety Act authorizes the listing of PSOs, which are entities or component organizations whose mission and primary activity are to conduct activities to improve patient safety and the quality of health care delivery. HHS issued the Patient Safety Rule to implement the Patient Safety Act. AHRQ administers the provisions of the Patient Safety Act and Patient Safety Rule relating to the listing and operation of PSOs. The Patient Safety Rule authorizes AHRQ to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ‘‘delisted’’ if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when the PSO’s listing expires. Section 3.108(d) of the Patient Safety Rule requires AHRQ to provide public notice when it removes an organization from the list of federally approved PSOs. AHRQ has accepted a notification from Open Safety Foundation, PSO number P0121, to voluntarily relinquish its status as a PSO. Accordingly, Open Safety Foundation was delisted effective at 12:00 Midnight ET (2400) on February 6, 2014. More information on PSOs can be obtained through AHRQ’s PSO Web site at http://www.pso.AHRQ.gov/ index.html. sroberts on DSK5TPTVN1PROD with NOTICES Dated: March 11, 2014. Richard Kronick, Director. [FR Doc. 2014–05999 Filed 3–18–14; 8:45 am] BILLING CODE 4160–90–P AGENCY: The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b–21 to b–26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, 73 FR 70732– 70814, provide for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of healthcare delivery. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ‘‘delisted’’ by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO’s listing expires. AHRQ has accepted a notification of voluntary relinquishment from WiMED, Inc. of its status as a PSO, and has delisted the PSO accordingly. DATES: The directories for both listed and delisted PSOs are ongoing and reviewed weekly by AHRQ. The delisting was effective at 12:00 Midnight ET (2400) on February 6, 2014. ADDRESSES: Both directories can be accessed electronically at the following HHS Web site: http:// www.pso.AHRQ.gov/index.html. FOR FURTHER INFORMATION CONTACT: Eileen Hogan, Center for Quality Improvement and Patient Safety, AHRQ, 540 Gaither Road, Rockville, MD 20850; Telephone (toll free): (866) 403–3697; Telephone (local): (301) 427–1111; TTY (toll free): (866) 438–7231; TTY (local): (301) 427–1130; Email: pso@ AHRQ.hhs.gov SUPPLEMENTARY INFORMATION: Background The Patient Safety Act authorizes the listing of PSOs, which are entities or component organizations whose mission and primary activity are to VerDate Mar<15>2010 18:28 Mar 18, 2014 Jkt 232001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 15345 conduct activities to improve patient safety and the quality of health care delivery. HHS issued the Patient Safety Rule to implement the Patient Safety Act. AHRQ administers the provisions of the Patient Safety Act and Patient Safety Rule relating to the listing and operation of PSOs. The Patient Safety Rule authorizes AHRQ to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ‘‘delisted’’ if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO’s listing expires Section 3.108(d) of the Patient Safety Rule requires AHRQ to provide public notice when it removes an organization from the list of federally approved PSOs. AHRQ has accepted a notification from WiMED, Inc., PSO number P0064, to voluntarily relinquish its status as a PSO. Accordingly, WiMED, Inc. was delisted effective at 12:00 Midnight ET (2400) on February 6, 2014. WiMED, Inc. has patient safety work product (PSWP) in its possession. The PSO will meet the requirements of section 3.108(c)(2)(i) of the Patient Safety Rule regarding notification to providers that have reported to the PSO. In addition, according to sections 3.108(c)(2)(ii) and 3.108(b)(3) of the Patient Safety Rule regarding disposition of PSWP, the PSO has 90 days from the effective date of delisting and revocation to complete the disposition of PSWP that is currently in the PSO’s possession. More information on PSOs can be obtained through AHRQ’s PSO Web site at http://www.pso.AHRQ.gov/ index.html. Dated: March 11. 2014. Richard Kronick, Director. [FR Doc. 2014–05998 Filed 3–18–14; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–14–0134] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on E:\FR\FM\19MRN1.SGM 19MRN1 15346 Federal Register / Vol. 79, No. 53 / Wednesday, March 19, 2014 / Notices proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404–639–7570 or send comments to Leroy Richardson, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an email to omb@cdc.gov. 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; 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. Written comments should be received within 60 days of this notice. Proposed Project Foreign Quarantine Regulations— Revision—(expiration date: July 31, 2015)—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Global Migration and Quarantine (DGMQ), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC is submitting this revision to obtain authority to collect electronic information from importers/filers on specific types of animals and cargo over which CDC has authority, notably those found in 42 CFR part 71. This request is consistent with requirements of the Security and Accountability for Every (SAFE) Port Act that states that all agencies that require documentation for estimated number of burden hours in the amount of 8,162. Of these additional hours, 7,862 pertain to requests for CDC Message Set data via ITDS/ACE, 167 hours pertain to required statements/ documentation of products being rendered non-infectious, and 133 hours pertain to a revised estimate of the number of CDC form 75.37 ‘‘NOTICE TO OWNERS AND IMPORTERS OF DOGS: Requirement for Dog Confinement required from importers of dogs. CDC also is providing wholly revised instructions for the Maritime Conveyance Cumulative Influenza/ Influenza-Like Illness (ILI) Form and Maritime Conveyance Illness or Death Investigations form. No additional burden is requested for this change, because no increase in complexity of instructions or reporting information is requested. Finally, CDC has removed burden totals for 42 CFR 71.52 Turtles, Tortoises and Terrapins (reduction of 3 hours from burden total); 42 CFR 71.55 Dead Bodies (reduction of 5 hours from burden total; and 42 CFR 71.56(a)(iii) and (c) Appeal—Appeal the denial of permit for importation of regulated animals; and Appeal for order of quarantine, destruction or re-export of regulated animals (reduction of 2 hours from burden total). CDC estimates that there are less than 10 occurrences a year when information is provided by a respondent pursuant to CDC requirements for importation. This results in a total reduction of 10 hours. Respondents to this data collection include airline pilots, ships’ captains, importers/filers, and travelers/general public. The nature of the response to CDC dictates which forms are completed by whom. There are no costs to respondents except for their time to complete the response. clearing or licensing the importation and exportation of cargo participate in the International Trade Data System (ITDS), and is also consistent with CDC authorities under Section 361 of the Public Health Service Act (PHSA)(42 U.S.C. 264). This electronic data is specified by CDC using Partner Government Agency (PGA) Message Sets and is collected by Customs and Border Protection (CBP) from importers/filers when they submit the information needed through International Trade Data System ITDS and the Automated Commercial Environment (ITDS/ACE) to clear an import. CDC has developed a PGA message set for each regulated import specified in 42 CFR part 71, and each PGA Message Set includes only those data requirements necessary in order to determine whether or not a CDCregulated import poses a risk to public health and that the importer has met CDC’s regulatory requirements for entry. CDC is including the PGA Message Sets for review because there is no set form or format for the electronic submission of import related data to CBP and CDC. CDC is permitted access to the Automated Commercial Environment (ACE) data pursuant to 6 CFR 29.8(b) and 49 CFR 1520.11(b), which permit federal employees with a need to know to have access to this data. CDC is maintaining its authority to collect hard copies of required documentation, as currently authorized by the Office of Management and Budget, because the use of ITDS/ACE will not be required for imports entering the United States until a later date. CDC will accept both hard copy and electronic filing of import-related documentation until the use of ACE is required for cargo entering the United States. Through this revision, CDC is requesting a net increase in the ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Form name/CFR reference Maritime conveyance operators ........ sroberts on DSK5TPTVN1PROD with NOTICES Type of respondent 71.21(a) Radio Report of death/illness—illness reports from ships (fillable PDF (individual case and cumulative report), phone, transcribed email). 71.21(b) Death/Illness reports from aircrafts (verbal, no form). 71.21(c) Gastrointestinal Illnesses reports 24 and 4 hours before arrival (MIDRS). 71.21(c) Recordkeeping—Medical logs (no form, captains provide logs). Aircraft commander or operators ...... Maritime conveyance operators ........ Maritime conveyance operators ........ VerDate Mar<15>2010 18:28 Mar 18, 2014 Jkt 232001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 Number of responses per respondent Average burden per response (in hours) Total burden hours 2,000 1 2/60 67 1,700 1 2/60 57 17,000 1 3/60 850 17,000 1 3/60 850 E:\FR\FM\19MRN1.SGM 19MRN1 15347 Federal Register / Vol. 79, No. 53 / Wednesday, March 19, 2014 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Form name/CFR reference Isolated or Quarantined individuals .. 71.33(c) Report by persons in isolation or surveillance (verbal, no form). 71.35 Report of death/illness during stay in port (verbal, no form). Locator Form used in an outbreak of public health significance. Locator Form used for reporting of an ill passenger(s). 71.51(b)(2) Dogs/cats: Certification of Confinement, Vaccination (CDC form 75.37). 71.51(b)(3) Dogs/cats: Record of sickness or deaths (no form, record review). CDC PGA Message Set for Importing Cats and Dogs. 71.56(a)(2) African Rodents—Request for exemption (no form, written request only). CDC PGA Message Set for Importing African Rodents. Statement or documentation of Noninfectiousness (Documented, no form; authority under 71.32(b)). CDC PGA Message Set for Importing African Rodent and All Family Viverridae Products. Average burden per response (in hours) Number of responses per respondent Number of respondents Type of respondent Total burden hours Aircraft commander or operators ...... Importer ............................................. Importer ............................................. Importer/Filer ..................................... Importer ............................................. Importer/Filer ..................................... Importer ............................................. Importer/Filer ..................................... 3/60 1 5 1 30/60 3 2,700,000 1 5/60 225,000 800 1 5/60 67 2,800 1 10/60 467 20 1 15/60 5 30,000 1 15/60 7,500 20 1 1 20 60 1 15/60 15 2,000 1 5/60 167 2,000 1 15/60 500 2,775,416 ........................ ........................ 235,569 Total 2: PLF used for reporting of an ill passenger(s). Aircraft commander or operators ...... 1 Total 1: PLF used in an outbreak of public health significance. Maritime conveyance operators ........ 11 75,416 ........................ ........................ 10,569 Leroy 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. comments to 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. [FR Doc. 2014–05946 Filed 3–18–14; 8:45 am] Proposed Project BILLING CODE 4163–18–P CDC Oral Health Management Information System (OMB No. 0920– 0739, exp. 4/30/2014)—Revision— Division of Oral Health, National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–14–0739] Background and Brief Description sroberts on DSK5TPTVN1PROD with NOTICES Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639–7570 or send an email to omb@cdc.gov. Send written VerDate Mar<15>2010 18:28 Mar 18, 2014 Jkt 232001 The CDC works with state health departments to improve the oral health of the nation. Targeted efforts include building and/or maintaining effective public health capacity for the implementation, evaluation, and dissemination of best practices in oral disease prevention and advancement of oral health. Through a cooperative agreement program (Program Announcement DP13–1307), CDC will provide funding to 21 states over a five- PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 year period. New cooperative agreements went into effect in September 2013 and build on previous funded collaboration involving CDC and state programs. CDC is currently approved to collect annual progress and activity reports from state-based oral health programs. An electronic reporting system has been in place since 2007 and was enhanced in 2008 to capture information about grantees’ success stories and environmental scanning activities. The information collected in the management information system (MIS) improved CDC’s ability to disseminate information about successful public health approaches that can be replicated or adapted for use in other states. CDC plans to implement changes to the existing information collection. Through a Revision request, CDC will increase the number of awardees from 20 to 21; describe changes in the MIS platform and data elements that will align the monitoring and evaluation framework for oral health awardees with the framework used for a number of other programs in the National Center E:\FR\FM\19MRN1.SGM 19MRN1

Agencies

[Federal Register Volume 79, Number 53 (Wednesday, March 19, 2014)]
[Notices]
[Pages 15345-15347]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05946]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-14-0134]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on

[[Page 15346]]

proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-7570 or 
send comments to Leroy Richardson, 1600 Clifton Road, MS-D74, Atlanta, 
GA 30333 or send an email to omb@cdc.gov.
    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; 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. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Foreign Quarantine Regulations--Revision--(expiration date: July 
31, 2015)--National Center for Emerging and Zoonotic Infectious 
Diseases (NCEZID), Division of Global Migration and Quarantine (DGMQ), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    CDC is submitting this revision to obtain authority to collect 
electronic information from importers/filers on specific types of 
animals and cargo over which CDC has authority, notably those found in 
42 CFR part 71. This request is consistent with requirements of the 
Security and Accountability for Every (SAFE) Port Act that states that 
all agencies that require documentation for clearing or licensing the 
importation and exportation of cargo participate in the International 
Trade Data System (ITDS), and is also consistent with CDC authorities 
under Section 361 of the Public Health Service Act (PHSA)(42 U.S.C. 
264).
    This electronic data is specified by CDC using Partner Government 
Agency (PGA) Message Sets and is collected by Customs and Border 
Protection (CBP) from importers/filers when they submit the information 
needed through International Trade Data System ITDS and the Automated 
Commercial Environment (ITDS/ACE) to clear an import. CDC has developed 
a PGA message set for each regulated import specified in 42 CFR part 
71, and each PGA Message Set includes only those data requirements 
necessary in order to determine whether or not a CDC-regulated import 
poses a risk to public health and that the importer has met CDC's 
regulatory requirements for entry. CDC is including the PGA Message 
Sets for review because there is no set form or format for the 
electronic submission of import related data to CBP and CDC. CDC is 
permitted access to the Automated Commercial Environment (ACE) data 
pursuant to 6 CFR 29.8(b) and 49 CFR 1520.11(b), which permit federal 
employees with a need to know to have access to this data.
    CDC is maintaining its authority to collect hard copies of required 
documentation, as currently authorized by the Office of Management and 
Budget, because the use of ITDS/ACE will not be required for imports 
entering the United States until a later date. CDC will accept both 
hard copy and electronic filing of import-related documentation until 
the use of ACE is required for cargo entering the United States.
    Through this revision, CDC is requesting a net increase in the 
estimated number of burden hours in the amount of 8,162. Of these 
additional hours, 7,862 pertain to requests for CDC Message Set data 
via ITDS/ACE, 167 hours pertain to required statements/documentation of 
products being rendered non-infectious, and 133 hours pertain to a 
revised estimate of the number of CDC form 75.37 ``NOTICE TO OWNERS AND 
IMPORTERS OF DOGS: Requirement for Dog Confinement required from 
importers of dogs.
    CDC also is providing wholly revised instructions for the Maritime 
Conveyance Cumulative Influenza/Influenza-Like Illness (ILI) Form and 
Maritime Conveyance Illness or Death Investigations form. No additional 
burden is requested for this change, because no increase in complexity 
of instructions or reporting information is requested.
    Finally, CDC has removed burden totals for 42 CFR 71.52 Turtles, 
Tortoises and Terrapins (reduction of 3 hours from burden total); 42 
CFR 71.55 Dead Bodies (reduction of 5 hours from burden total; and 42 
CFR 71.56(a)(iii) and (c) Appeal--Appeal the denial of permit for 
importation of regulated animals; and Appeal for order of quarantine, 
destruction or re-export of regulated animals (reduction of 2 hours 
from burden total). CDC estimates that there are less than 10 
occurrences a year when information is provided by a respondent 
pursuant to CDC requirements for importation. This results in a total 
reduction of 10 hours.
    Respondents to this data collection include airline pilots, ships' 
captains, importers/filers, and travelers/general public. The nature of 
the response to CDC dictates which forms are completed by whom. There 
are no costs to respondents except for their time to complete the 
response.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondent          Form name/CFR      Number of     responses per   per response    Total burden
                                    reference       respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Maritime conveyance operators.  71.21(a) Radio             2,000               1            2/60              67
                                 Report of death/
                                 illness--illnes
                                 s reports from
                                 ships (fillable
                                 PDF (individual
                                 case and
                                 cumulative
                                 report), phone,
                                 transcribed
                                 email).
Aircraft commander or           71.21(b) Death/            1,700               1            2/60              57
 operators.                      Illness reports
                                 from aircrafts
                                 (verbal, no
                                 form).
Maritime conveyance operators.  71.21(c)                  17,000               1            3/60             850
                                 Gastrointestina
                                 l Illnesses
                                 reports 24 and
                                 4 hours before
                                 arrival (MIDRS).
Maritime conveyance operators.  71.21(c)                  17,000               1            3/60             850
                                 Recordkeeping--
                                 Medical logs
                                 (no form,
                                 captains
                                 provide logs).

[[Page 15347]]

 
Isolated or Quarantined         71.33(c) Report               11               1            3/60               1
 individuals.                    by persons in
                                 isolation or
                                 surveillance
                                 (verbal, no
                                 form).
Maritime conveyance operators.  71.35 Report of                5               1           30/60               3
                                 death/illness
                                 during stay in
                                 port (verbal,
                                 no form).
Aircraft commander or           Locator Form           2,700,000               1            5/60         225,000
 operators.                      used in an
                                 outbreak of
                                 public health
                                 significance.
Aircraft commander or           Locator Form                 800               1            5/60              67
 operators.                      used for
                                 reporting of an
                                 ill
                                 passenger(s).
Importer......................  71.51(b)(2) Dogs/          2,800               1           10/60             467
                                 cats:
                                 Certification
                                 of Confinement,
                                 Vaccination
                                 (CDC form
                                 75.37).
Importer......................  71.51(b)(3) Dogs/             20               1           15/60               5
                                 cats: Record of
                                 sickness or
                                 deaths (no
                                 form, record
                                 review).
Importer/Filer................  CDC PGA Message           30,000               1           15/60           7,500
                                 Set for
                                 Importing Cats
                                 and Dogs.
Importer......................  71.56(a)(2)                   20               1               1              20
                                 African
                                 Rodents--Reques
                                 t for exemption
                                 (no form,
                                 written request
                                 only).
Importer/Filer................  CDC PGA Message               60               1           15/60              15
                                 Set for
                                 Importing
                                 African Rodents.
Importer......................  Statement or               2,000               1            5/60             167
                                 documentation
                                 of Non-
                                 infectiousness
                                 (Documented, no
                                 form; authority
                                 under 71.32(b)).
Importer/Filer................  CDC PGA Message            2,000               1           15/60             500
                                 Set for
                                 Importing
                                 African Rodent
                                 and All Family
                                 Viverridae
                                 Products.
                               ---------------------------------------------------------------------------------
                                Total 1: PLF           2,775,416  ..............  ..............         235,569
                                 used in an
                                 outbreak of
                                 public health
                                 significance.
                               ---------------------------------------------------------------------------------
                                Total 2: PLF              75,416  ..............  ..............          10,569
                                 used for
                                 reporting of an
                                 ill
                                 passenger(s).
----------------------------------------------------------------------------------------------------------------


Leroy 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. 2014-05946 Filed 3-18-14; 8:45 am]
BILLING CODE 4163-18-P