80 FR 76692 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 237 (December 10, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 237 (December 10, 2015)
| Page Range | 76692-76693 | |
| FR Document | 2015-31105 |
[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)] [Notices] [Pages 76692-76693] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31105] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-16-0488] 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 [email protected]. 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 by fax to (202) 395-5806. Written comments should be received within 30 days of this notice. Proposed Project Restrictions on Interstate Travel of Persons (42 CFR part 70) (OMB Control No. 0920-0488, expiration, 3/31/2016)-- Revision--Division of Global Migration and Quarantine, National Center for Emerging Zoonotic and Infectious Diseases, Centers for Disease Control and Prevention (CDC). Background and Brief Description This revision to an existing information collection request is intended to ensure that CDC can continue collect pertinent information related to communicable disease or deaths that occur aboard conveyances during interstate travel within the United States, as authorized under 42 Code of Federal Regulations (CFR) part 70. Additionally, CDC is requesting approval to use the Passenger Locator Form in the event that travelers on domestic flights within the United States need to be contacted for public health follow-up. The intended use of the information is to ensure that CDC can assess and respond to reports of communicable disease or death that occur on conveyances engaged in interstate travel, and assist state and local health authorities if an illness or death occurs that poses a risk to public health. Generally, the primary source of this information is aircraft and travelers moving within the United States. This revision makes several modification to this information collection. They are as follows: In current practice, CDC does not process applications for travel permits using the Restriction On Travel Of Persons Multipurpose Application Form Under the Provisions of 42 CFR part 70 (aka Ill Person Travel Permit); therefore the information collections under 42 CFR 70.3, Application to the State of destination for a permit, Copy of material submitted by applicant and permit issued by State health authority (Attending physician), and Copy of material submitted by applicant and permit issued by State health authority (State health authority) are being removed. Similarly, information collections under 42 CFR 70.5, Application for a permit to move from State to State while in the communicable period (Attending physician) and Application for a permit to move from State to State while in the communicable period (Traveler) are also being removed. The issuance of travel restrictions is a collaborative process between public health partners, e.g. state health departments, the Department of Homeland Security, and CDC. There is no standardized collection of information involved. This change results in the removal of the information collections under 42 CFR 70.3 and 70.5 from the list of information collections as well as the removal of the associated burden. Reports of communicable disease or death from domestic conveyances are almost always submitted electronically to meet requirements of 42 CFF 70.4, so the current hard copy Master of Vessel or Conveyance Illness Report, which was constructed to be used by masters of vessels to comply with 42 CFR 70.4, has been rendered obsolete. In addition, CDC has issued guidance stating that reports to CDC, instead of local health authorities, regarding domestic reports of communicable disease or death on board conveyances meet the requirements of the regulation; therefore, information collections related to copies of the report sent by masters of vessels to state health departments are no longer necessary. The only remaining information collection under 42 CFR 70.4 is Report by the master of a vessel or person in charge of conveyance of the incidence of a communicable disease occurring while in interstate travel. [[Page 76693]] CDC is also requesting an adjustment to the burden associated with reports of communicable disease or death from domestic conveyances. CDC is reducing the burden from 15 minutes per report to 7 minutes. This is due to the facilitation of reporting using electronic means, i.e. Air Traffic Control and the Domestic Events Network for domestic flights, rather than the hard copy Master of Vessel or Conveyance Illness Report. Finally, CDC is requesting the addition of the Passenger Locator Form to this information collection. CDC currently has approval to collect the Passenger Locator Form from travelers aboard international flights under OMB Control Number 0920-0134. CDC is requesting approval to collect passenger contact and locating information for travelers aboard domestic flights within the United States. The resulting change in burden is a reduction of 3,611 hours. Estimated Annualized Burden Hours CDC anticipates this information collection will result in 90 total burden hours from 1,000 respondents. There is no burden to respondents other than the time required to complete and send the requested information to CDC. The estimated annualized burden is 90 hours. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Type of respondent Form name respondents responses per response (in respondent hours) ---------------------------------------------------------------------------------------------------------------- Master of a vessel or person in charge 42 CFR 70.4 Report by 200 1 7/60 of a conveyance. the master of a vessel or person in charge of conveyance of the incidence of a communicable disease occurring while in interstate travel. Traveler.............................. Passenger Locator Form.. 800 1 5/60 ---------------------------------------------------------------------------------------------------------------- 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. 2015-31105 Filed 12-9-15; 8:45 am] BILLING CODE 4163-18-P
![76692 Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices
ESTIMATE OF ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)
Clinic ............................................................... Demographic Clinical Data Form 1 ................ 30 240 11/60
Laboratory ....................................................... Antimicrobial Susceptibility Testing Form 2 ... 5 1,452 1
Control Strain Susceptibility Testing Form 3 5 48 12/60
Leroy A. Richardson, To request additional information on the Provisions of 42 CFR part 70 (aka Ill
Chief, Information Collection Review Office, the proposed project or to obtain a copy Person Travel Permit); therefore the
Office of Scientific Integrity, Office of the of the information collection plan and information collections under 42 CFR
Associate Director for Science, Office of the instruments, call (404) 639–7570 or 70.3, Application to the State of
Director, Centers for Disease Control and send an email to omb@cdc.gov. Written destination for a permit, Copy of
Prevention. comments and/or suggestions regarding material submitted by applicant and
[FR Doc. 2015–31104 Filed 12–9–15; 8:45 am] the items contained in this notice permit issued by State health authority
BILLING CODE 4163–18–P should be directed to the Attention: (Attending physician), and Copy of
CDC Desk Officer, Office of Management material submitted by applicant and
and Budget, Washington, DC 20503 or permit issued by State health authority
DEPARTMENT OF HEALTH AND by fax to (202) 395–5806. Written
HUMAN SERVICES (State health authority) are being
comments should be received within 30 removed. Similarly, information
days of this notice. collections under 42 CFR 70.5,
Centers for Disease Control and
Prevention Proposed Project Application for a permit to move from
Restrictions on Interstate Travel of State to State while in the
[30Day–16–0488] Persons (42 CFR part 70) (OMB Control communicable period (Attending
No. 0920–0488, expiration, 3/31/ physician) and Application for a permit
Agency Forms Undergoing Paperwork 2016)— Revision—Division of Global to move from State to State while in the
Reduction Act Review Migration and Quarantine, National communicable period (Traveler) are also
Center for Emerging Zoonotic and being removed. The issuance of travel
The Centers for Disease Control and restrictions is a collaborative process
Prevention (CDC) has submitted the Infectious Diseases, Centers for Disease
Control and Prevention (CDC). between public health partners, e.g.
following information collection request state health departments, the
to the Office of Management and Budget Background and Brief Description Department of Homeland Security, and
(OMB) for review and approval in This revision to an existing CDC. There is no standardized
accordance with the Paperwork information collection request is collection of information involved. This
Reduction Act of 1995. The notice for intended to ensure that CDC can change results in the removal of the
the proposed information collection is continue collect pertinent information information collections under 42 CFR
published to obtain comments from the related to communicable disease or
public and affected agencies. 70.3 and 70.5 from the list of
deaths that occur aboard conveyances information collections as well as the
Written comments and suggestions during interstate travel within the
from the public and affected agencies removal of the associated burden.
United States, as authorized under 42 Reports of communicable disease or
concerning the proposed collection of Code of Federal Regulations (CFR) part
information are encouraged. Your death from domestic conveyances are
70. Additionally, CDC is requesting almost always submitted electronically
comments should address any of the approval to use the Passenger Locator
following: (a) Evaluate whether the to meet requirements of 42 CFF 70.4, so
Form in the event that travelers on the current hard copy Master of Vessel
proposed collection of information is domestic flights within the United
necessary for the proper performance of or Conveyance Illness Report, which
States need to be contacted for public was constructed to be used by masters
the functions of the agency, including health follow-up.
whether the information will have The intended use of the information of vessels to comply with 42 CFR 70.4,
practical utility; (b) Evaluate the is to ensure that CDC can assess and has been rendered obsolete. In addition,
accuracy of the agencies estimate of the respond to reports of communicable CDC has issued guidance stating that
burden of the proposed collection of disease or death that occur on reports to CDC, instead of local health
information, including the validity of conveyances engaged in interstate authorities, regarding domestic reports
the methodology and assumptions used; travel, and assist state and local health of communicable disease or death on
(c) Enhance the quality, utility, and authorities if an illness or death occurs board conveyances meet the
clarity of the information to be that poses a risk to public health. requirements of the regulation;
collected; (d) Minimize the burden of Generally, the primary source of this therefore, information collections
the collection of information on those information is aircraft and travelers related to copies of the report sent by
masters of vessels to state health
mstockstill on DSK4VPTVN1PROD with NOTICES
who are to respond, including through moving within the United States.
the use of appropriate automated, This revision makes several departments are no longer necessary.
electronic, mechanical, or other modification to this information The only remaining information
technological collection techniques or collection. They are as follows: In collection under 42 CFR 70.4 is Report
other forms of information technology, current practice, CDC does not process by the master of a vessel or person in
e.g., permitting electronic submission of applications for travel permits using the charge of conveyance of the incidence of
responses; and (e) Assess information Restriction On Travel Of Persons a communicable disease occurring
collection costs. Multipurpose Application Form Under while in interstate travel.
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![Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices 76693
CDC is also requesting an adjustment Finally, CDC is requesting the The resulting change in burden is a
to the burden associated with reports of addition of the Passenger Locator Form reduction of 3,611 hours.
communicable disease or death from to this information collection. CDC Estimated Annualized Burden Hours
domestic conveyances. CDC is reducing currently has approval to collect the
the burden from 15 minutes per report Passenger Locator Form from travelers CDC anticipates this information
to 7 minutes. This is due to the aboard international flights under OMB collection will result in 90 total burden
facilitation of reporting using electronic Control Number 0920–0134. CDC is hours from 1,000 respondents. There is
means, i.e. Air Traffic Control and the requesting approval to collect passenger no burden to respondents other than the
Domestic Events Network for domestic contact and locating information for time required to complete and send the
requested information to CDC. The
flights, rather than the hard copy Master travelers aboard domestic flights within
estimated annualized burden is 90
of Vessel or Conveyance Illness Report. the United States.
hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondent Form name responses per
respondents response
respondent (in hours)
Master of a vessel or person in charge of a 42 CFR 70.4 Report by the master of a ves- 200 1 7/60
conveyance. sel or person in charge of conveyance of
the incidence of a communicable disease
occurring while in interstate travel.
Traveler ........................................................... Passenger Locator Form ............................... 800 1 5/60
Leroy A. Richardson, Furthermore, any interested person may Written/Paper Submissions
Chief, Information Collection Review Office, petition FDA for a determination Submit written/paper submissions as
Office of Scientific Integrity, Office of the regarding whether the applicant for
Associate Director for Science, Office of the follows:
extension acted with due diligence
Director, Centers for Disease Control and • Mail/Hand delivery/Courier (for
during the regulatory review period by
Prevention. written/paper submissions): Division of
June 7, 2016. See ‘‘Petitions’’ in the
[FR Doc. 2015–31105 Filed 12–9–15; 8:45 am] Dockets Management (HFA–305), Food
SUPPLEMENTARY INFORMATION section for
and Drug Administration, 5630 Fishers
BILLING CODE 4163–18–P more information.
Lane, Rm. 1061, Rockville, MD 20852.
ADDRESSES: You may submit comments • For written/paper comments
DEPARTMENT OF HEALTH AND as follows: submitted to the Division of Dockets
HUMAN SERVICES Electronic Submissions Management, FDA will post your
comment, as well as any attachments,
Food and Drug Administration Submit electronic comments in the except for information submitted,
following way: marked and identified, as confidential,
[Docket Nos. FDA–2014–E–0308 and FDA– • Federal eRulemaking Portal: http:// if submitted as detailed in
2014–E–0309]
www.regulations.gov. Follow the ‘‘Instructions.’’
Determination of Regulatory Review instructions for submitting comments. Instructions: All submissions received
Period for Purposes of Patent Comments submitted electronically, must include the Docket Nos. FDA–
Extension; FULYZAQ including attachments, to http:// 2014–E–0308 and FDA–2014–E–0309
www.regulations.gov will be posted to for ‘‘Determination of Regulatory
AGENCY: Food and Drug Administration, the docket unchanged. Because your Review Period for Purposes of Patent
HHS. comment will be made public, you are Extension; FULYZAQ.’’ Received
ACTION: Notice. solely responsible for ensuring that your comments will be placed in the dockets
comment does not include any and, except for those submitted as
SUMMARY: The Food and Drug confidential information that you or a ‘‘Confidential Submissions,’’ publicly
Administration (FDA) has determined third party may not wish to be posted, viewable at http://www.regulations.gov
the regulatory review period for such as medical information, your or or at the Division of Dockets
FULYZAQ and is publishing this notice anyone else’s Social Security number, or Management between 9 a.m. and 4 p.m.,
of that determination as required by confidential business information, such Monday through Friday.
law. FDA has made the determination as a manufacturing process. Please note • Confidential Submissions—To
because of the submission of an that if you include your name, contact submit a comment with confidential
application to the Director of the U.S. information, or other information that information that you do not wish to be
Patent and Trademark Office (USPTO), identifies you in the body of your made publicly available, submit your
Department of Commerce, for the comments, that information will be comments only as a written/paper
extension of a patent which claims that posted on http://www.regulations.gov.
mstockstill on DSK4VPTVN1PROD with NOTICES
submission. You should submit two
human drug product. • If you want to submit a comment copies total. One copy will include the
DATES: Anyone with knowledge that any with confidential information that you information you claim to be confidential
of the dates as published (in the do not wish to be made available to the with a heading or cover note that states
SUPPLEMENTARY INFORMATION section) are public, submit the comment as a ‘‘THIS DOCUMENT CONTAINS
incorrect may submit either electronic written/paper submission and in the CONFIDENTIAL INFORMATION’’. The
or written comments and ask for a manner detailed (see ‘‘Written/Paper Agency will review this copy, including
redetermination by February 8, 2016. Submissions’’ and ‘‘Instructions’’). the claimed confidential information, in
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Document Created: 2015-12-14 13:29:33
Document Modified: 2015-12-14 13:29:33
| 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 76692 |
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