82 FR 36144 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 82, Issue 148 (August 3, 2017)
Centers for Disease Control and Prevention
Federal Register Volume 82, Issue 148 (August 3, 2017)
| Page Range | 36144-36146 | |
| FR Document | 2017-16333 |
[Federal Register Volume 82, Number 148 (Thursday, August 3, 2017)] [Notices] [Pages 36144-36146] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16333] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-17-0576] 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 [[Page 36145]] 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 Possession, Use, and Transfer of Select Agents and Toxins (42 CFR part 73)--Revision--Centers for Disease Control and Prevention (CDC)/ Division of Select Agents and Toxins (DSAT) and United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS)/Agriculture Select Agent Services (AgSAS). Background and Brief Description Subtitle A of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, (42 U.S.C. 262a), requires the United States Department of Health and Human Services (HHS) to regulate the possession, use, and transfer of biological agents or toxins that have the potential to pose a severe threat to public health and safety (select agents and toxins). Subtitle B of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (which may be cited as the Agricultural Bioterrorism Protection Act of 2002), (7 U.S.C. 8401), requires USDA to regulate the possession, use, and transfer of biological agents or toxins that have the potential to pose a severe threat to animal or plant health, or animal or plant products (select agents and toxins). The HHS Secretary delegated the responsibility for promulgating and implementing select agent regulations found at 42 CFR part 73 to CDC Division of Select Agents and Toxins (DSAT). The United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS)/Agriculture Select Agent Services (AgSAS) was delegated responsibility by USDA for select agent regulations (7 CFR part 331, and 9 CFR part 121). The Federal Select Agent Program (FSAP) is the collaboration of the DSAT and AgSAS to administer the select agent regulations in a manner to minimize the administrative burden on persons subject to the select agent regulations. Accordingly, CDC and APHIS have adopted an identical system to collect information for the possession, use, and transfer of select agents and toxins. CDC is requesting OMB approval to revise the collected information under the select agent regulations through the use of the APHIS/CDC Form 3 (Incident Notification and Reporting (Theft/Loss/Release)). The form (42 CFR 73.19(a),(b)) must be completed by an individual or an entity whenever the individual or entity experiences a theft, loss, or release of a select agent or toxin. CDC is proposing to revise the form to further clarify what needs to be reported as a ``release'' and ``loss'' and additional fields to assist with categorizing the type of release (e.g., spill within secondary containment, occupational exposure, possible breach of facility containment, etc.), type of exposure, and the understanding of safety and security risk levels relative to human illness. Guidance documents were also added to assist with the following forms: Application for Registration (APHIS/CDC Form 1), Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2), Report of Identification of a Select Agent or Toxin (APHIS/CDC Form 4), Request of Exemption of Select Agents and Request for Exclusions Toxins for an Investigational Product (APHIS/CDC Form 5), Request for Expedited Review, Security Plan, Security Plan, Biosafety Plan, Request Regarding a Restricted Experiment, Incident Response Plan, Training, and Records. Annualized burden hours and cost were calculated based on data obtained from 2016 Annual Report of the Federal Select Agent Program for submissions to FSAP for 2016. CDC requests a three year approval for this Revision. The estimated annualized Burden has been reduced to 8,408 hours due to the decrease in the number of Respondents. There is no cost to Respondents other than their time. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Section Form name Number of responses per per response respondents respondent (in hours) ---------------------------------------------------------------------------------------------------------------- 73.7........................... Application for Registration 1 1 4 (APHIS/CDC Form 1). 73.7........................... Amendment to a Certificate of 238 7 1 Registration. 73.7........................... Application for Registration 1 1 1 (APHIS/CDC Form 1) Guidance. 73.16.......................... Request to Transfer Select 188 1 1 Agents and Toxins (APHIS/CDC Form 2). 73.16.......................... Request to Transfer Select 188 1 30/60 Agents and Toxins (APHIS/CDC Form 2) Guidance. 73.19.......................... Report of Theft, Loss, or 205 1 90/60 Release of Select Agent or Toxin (APHIS/CDC Form 3). 73.19.......................... Report of Theft, Loss, or 205 1 30/60 Release of Select Agent or Toxin (APHIS/CDC Form 3) Guidance. 73.5 & 6....................... Report of Identification of a 1,030 1 30/60 Select Agent or Toxin from a Clinical/Diagnostic Specimen (APHIS/CDC Form 4A). 73.5 & 6....................... Report of Identification of a 10 1 30/60 Select Agent or Toxin from a Proficiency Test (APHIS/CDC Form 4B). [[Page 36146]] 73.5 & 6....................... Federal Law Enforcement 1 1 30/60 Reporting Seizure of Select Agent or Toxin (APHIS/CDC Form 4C). 73.5 & 6....................... Report of Identification of a 1,030 1 30/60 Select Agent or Toxin (APHIS/ CDC Form 4) Guidance. 73.5 & 73.6.................... Request of Exemption of Select 1 1 30/60 Agents and Toxins for an Investigational Product (APHIS/ CDC Form 5). 73.5 & 73.6.................... Request of Exemption of Select 1 1 30/60 Agents and Toxins for an Investigational Product (APHIS/ CDC Form 5) Guidance. 73.3 & 73.4.................... Request for Exclusions......... 3 1 30/60 73.3 & 73.4.................... Request for Exclusions Guidance 3 1 30/60 73.9........................... Documentation of Self- 238 1 1 inspection. 73.1........................... Request for Expedited Review... 1 1 15/60 73.1........................... Request for Expedited Review 1 1 15/60 Guidance. 73.11.......................... Security Plan.................. 238 1 5 73.11.......................... Security Plan Guidance......... 238 1 30/60 73.11.......................... Security Plan Template......... 238 1 30/60 73.12.......................... Biosafety Plan................. 238 1 5 73.12.......................... Biosafety Plan Guidance........ 238 1 30/60 73.12.......................... Biosafety Plan Template........ 238 1 30/60 73.13.......................... Request Regarding a Restricted 1 1 30/60 Experiment. 73.13.......................... Request Regarding a Restricted 1 1 30/60 Experiment Guidance. 73.14.......................... Incident Response Plan......... 238 1 5 73.14.......................... Incident Response Plan Guidance 238 1 30/60 73.14.......................... Incident Response Plan Template 238 1 30/60 73.15.......................... Training....................... 238 1 30/60 73.15.......................... Training Guidance.............. 238 1 30/60 73.17.......................... Records........................ 238 1 30/60 73.17.......................... Guidance on the Inventory of 238 1 30/60 Select Agents. 73.20.......................... Administrative Review.......... 1 1 1 ---------------------------------------------------------------------------------------------------------------- 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. 2017-16333 Filed 8-2-17; 8:45 am] BILLING CODE 4163-18-P
![36144 Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Notices
revised estimates reflect input obtained time spent by the various employees rates obtained from the Department of
by the EEOC during a limited survey of who have a role in preparing an EEO– Labor 2 for each job identified above as
school districts with varying resource 5, the EEOC estimates that a school participating in the submission of the
levels and student populations. The district will spend 17.07 hours to survey; the burden hour cost per school
school districts provided information on prepare the report, and estimates that district will be approximately $539.57,
the types of employees that participate the aggregate biennial hour burden for while the estimated total biennial
in preparation of the EEO–5 report and all respondents is 102,839.32. The cost burden cost for all 6024 school districts
the amount of time spent by each type associated with the burden hours was will be $3,250,361.25 (See Table 1 3).
of employee. After accounting for the calculated using median hourly wage
TABLE 1—ESTIMATE OF BURDEN FOR EEO–5 REPORT
Burden hour
Hourly Burden hours Total burden Total burden
cost per
wage rate per district hours 5 hour cost 6
district 4
N = 6024
COMPUTER SUPPORT SPECIALIST (IT PROFES-
SIONAL/DATA PROCESSING SPECIALIST) ................. 25.21 3.4286 86.4343 20653.7143 520680.1371
DIRECTOR OF SCHOOL FINANCE (FINANCIAL MAN-
AGERS) ............................................................................ 56.73 0.1429 8.1043 860.5714 48820.2171
EXECUTIVE CLERICAL STAFF ......................................... 26.66 2.9286 78.0757 17641.7143 470328.1029
HUMAN RESOURCE SPECIALIST .................................... 28.06 5.4286 152.3257 32701.7143 917610.1029
PAYROLL SPECIALIST ....................................................... 20.26 1.4286 28.9429 8605.7143 174351.7714
SENIOR HUMAN RESOURCE MANAGERS ...................... 50.21 3.4286 172.1486 20653.7143 1037022.9943
SUPERINTENDENT (SCHOOL MANAGEMENT OCCU-
PATIONS .......................................................................... 47.38 0.2857 13.5371 1721.1429 81547.7486
SUB TOTAL .................................................................. ........................ 17.0716 539.5686 102839.3184 3250361.2464
These estimates are based on an FEDERAL RESERVE SYSTEM family trusts, all of Rochester,
assumption of paper reporting. Minnesota; to retain control of the
However, the EEOC has made electronic Change in Bank Control Notices; voting shares of Sterling Financial
filing much easier for respondents Acquisitions of Shares of a Bank or Group, Inc., Rochester, Minnesota, and
required to file the EEO–5 Report. As a Bank Holding Company thereby indirectly retain control of
result, more respondents are using this Sterling State Bank, Austin, Minnesota.
The notificants listed below have
filing method. This development, along applied under the Change in Bank Board of Governors of the Federal Reserve
with the greater availability of human Control Act (12 U.S.C. 1817(j)) and System, July 28, 2017.
resource information software, is § 225.41 of the Board’s Regulation Y (12 Yao-Chin Chao,
expected to significantly reduce the CFR 225.41) to acquire shares of a bank Assistant Secretary of the Board.
actual burden of reporting. The or bank holding company. The factors [FR Doc. 2017–16292 Filed 8–2–17; 8:45 am]
Commission continues to develop more that are considered in acting on the BILLING CODE 6210–01–P
reliable estimates of reporting burdens notices are set forth in paragraph 7 of
given the significant increase in the Act (12 U.S.C. 1817(j)(7)).
electronic filing and explore new The notices are available for DEPARTMENT OF HEALTH AND
approaches to make such reporting even immediate inspection at the Federal HUMAN SERVICES
less burdensome. In order to help Reserve Bank indicated. The notices
reduce survey burden, respondents are also will be available for inspection at Centers for Disease Control and
encouraged to report data electronically, the offices of the Board of Governors. Prevention
whenever possible. Interested persons may express their
[30Day–17–0576]
views in writing to the Reserve Bank
Dated: July 24, 2017. indicated for that notice or to the offices Agency Forms Undergoing Paperwork
For the Commission. of the Board of Governors. Comments Reduction Act Review
Victoria A. Lipnic, must be received not later than August
Acting Chair. 17, 2017. The Centers for Disease Control and
[FR Doc. 2017–16340 Filed 8–2–17; 8:45 am]
A. Federal Reserve Bank of Prevention (CDC) has submitted the
Minneapolis (Brendan S. Murrin, following information collection request
BILLING CODE 6570–01–P
Assistant Vice President) 90 Hennepin to the Office of Management and Budget
Avenue, Minneapolis, Minnesota (OMB) for review and approval in
55480–0291: accordance with the Paperwork
1. Boyd Brent Myers, Tazewell, Reduction Act of 1995. The notice for
mstockstill on DSK30JT082PROD with NOTICES
Tennessee, as trustee of six McNeilus the proposed information collection is
2 Median hourly wage rates were obtained from 4 The figures in this column were calculated by District column by 6024, the total number of
the Bureau of Labor Statistics (see U.S. Dept. of multiplying the figures in the Hourly Wage Rate respondents.
Labor, Bureau of Labor Statistics, Occupational column by those in the Burden Hours Per District 6 The figures in this column were calculated by
Outlook Handbook, http://www/bls.gov/ooh/) Column. multiplying the figures in the Burden Hour Cost Per
5 The figures in this column were calculated by District column by 6024, the total number of
3 Figures shown in table have been rounded.
multiplying the figures in the Burden Hours Per respondents.
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![36146 Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Number of burden per
Section Form name responses per
respondents response
respondent (in hours)
73.5 & 6 ............. Federal Law Enforcement Reporting Seizure of Select Agent or Toxin 1 1 30/60
(APHIS/CDC Form 4C).
73.5 & 6 ............. Report of Identification of a Select Agent or Toxin (APHIS/CDC Form 4) 1,030 1 30/60
Guidance.
73.5 & 73.6 ........ Request of Exemption of Select Agents and Toxins for an Investigational 1 1 30/60
Product (APHIS/CDC Form 5).
73.5 & 73.6 ........ Request of Exemption of Select Agents and Toxins for an Investigational 1 1 30/60
Product (APHIS/CDC Form 5) Guidance.
73.3 & 73.4 ........ Request for Exclusions ................................................................................ 3 1 30/60
73.3 & 73.4 ........ Request for Exclusions Guidance ............................................................... 3 1 30/60
73.9 ................... Documentation of Self-inspection ................................................................ 238 1 1
73.1 ................... Request for Expedited Review .................................................................... 1 1 15/60
73.1 ................... Request for Expedited Review Guidance .................................................... 1 1 15/60
73.11 ................. Security Plan ................................................................................................ 238 1 5
73.11 ................. Security Plan Guidance ............................................................................... 238 1 30/60
73.11 ................. Security Plan Template ................................................................................ 238 1 30/60
73.12 ................. Biosafety Plan .............................................................................................. 238 1 5
73.12 ................. Biosafety Plan Guidance ............................................................................. 238 1 30/60
73.12 ................. Biosafety Plan Template .............................................................................. 238 1 30/60
73.13 ................. Request Regarding a Restricted Experiment .............................................. 1 1 30/60
73.13 ................. Request Regarding a Restricted Experiment Guidance ............................. 1 1 30/60
73.14 ................. Incident Response Plan ............................................................................... 238 1 5
73.14 ................. Incident Response Plan Guidance .............................................................. 238 1 30/60
73.14 ................. Incident Response Plan Template ............................................................... 238 1 30/60
73.15 ................. Training ........................................................................................................ 238 1 30/60
73.15 ................. Training Guidance ........................................................................................ 238 1 30/60
73.17 ................. Records ........................................................................................................ 238 1 30/60
73.17 ................. Guidance on the Inventory of Select Agents ............................................... 238 1 30/60
73.20 ................. Administrative Review .................................................................................. 1 1 1
Leroy A. Richardson, VAERS–1 Form which had been in use vaccines. Patients, parents and others
Chief, Information Collection Review Office, since 1990. aware of adverse events can also submit
Office of Scientific Integrity, Office of the DATES: The VAERS 2.0 Form was VAERS reports. Although VAERS is not
Associate Director for Science, Office of the implemented June 30, 2017. designed to assess if a vaccine caused an
Director, Centers for Disease Control and adverse event, VAERS provides HHS/
Prevention. FOR FURTHER INFORMATION CONTACT:
Tiffany Suragh, National Center for CDC and HHS/FDA with important
[FR Doc. 2017–16333 Filed 8–2–17; 8:45 am]
Emerging and Zoonotic Infectious early information that might signal a
BILLING CODE 4163–18–P potential problem. If the VAERS data
Diseases, Centers for Disease Control
and Prevention, 1600 Clifton Road NE., suggest a possible association between
Mailstop D–26; Atlant, Georgia 30329– an adverse event and vaccination, the
DEPARTMENT OF HEALTH AND
4018; Telephone: (404) 498–0681. relationship will be further assessed. In
HUMAN SERVICES
recent years VAERS has received
SUPPLEMENTARY INFORMATION: VAERS is
Centers for Disease Control and approximately 40,000 U.S. reports
an important and critical ‘‘early warning
Prevention annually.
system’’ in the federal vaccine safety
infrastructure for identifying adverse VAERS is a mandated activity for the
[Docket No. CDC–2014–0015] events after receipt of childhood, Department of Health and Human
adolescent, and adult vaccines licensed Services (HHS) and VAERS data are
Vaccines Adverse Event Reporting for use in the United States. Healthcare used by Federal agencies, State Health
System (VAERS) 2.0 Form providers and vaccine manufacturers Officials, health care providers,
are required under section 2125(b) of manufacturers, and the public.
AGENCY: Centers for Disease Control and the Public Health Service Act (42 U.S.C. Therefore, it is important to maximize
Prevention (CDC), Department of Health 300aa–25(b)) to submit VAERS reports the usefulness of this system. The
and Human Services (HHS). regarding the occurrence of any event information collected by the final
ACTION: Notice. set forth in the Vaccine Injury Table VAERS 2.0 Form will be similar to that
which occurs within 7 days of the from the current VAERS–1 Form so
SUMMARY: The Centers for Disease administration of any vaccine set forth historical comparisons can be made.
mstockstill on DSK30JT082PROD with NOTICES
Control and Prevention (CDC), located in the Table or within such longer However, the changes in the final
within the Department of Health and period as is specified in the Table and VAERS 2.0 Form should improve
Human Services (HHS) announces the the occurrence of any contraindicating reporting efficiency and data quality.
availability of the final Vaccines reaction to a vaccine which is specified VAERS 2.0 Form offers standardized
Adverse Event Reporting System in the manufacturer’s package insert. responses, clearer instructions and
(VAERS) 2.0 Form www.vaers.hhs.gov. VAERS also accepts reports on adverse guidance, and improved online
The VAERS 2.0 Form replaces the events following receipt of other reporting capability. Select questions
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Document Created: 2017-08-03 07:25:09
Document Modified: 2017-08-03 07:25:09
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