81 FR 70423 - Statement of Organization, Functions, and Delegations of Authority
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 197 (October 12, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 197 (October 12, 2016)
| Page Range | 70423-70425 | |
| FR Document | 2016-24640 |
[Federal Register Volume 81, Number 197 (Wednesday, October 12, 2016)] [Notices] [Pages 70423-70425] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-24640] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Statement of Organization, Functions, and Delegations of Authority Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 67772-76, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 81 FR 66284-66285, [[Page 70424]] dated September 27, 2016) is amended to reflect the reorganization of the Division of Scientific Resources, National Center for Emerging and Zoonotic Infectious Diseases, Office of Infectious Diseases, Centers for Disease Control and Prevention. Section C-B, Organization and Functions, is hereby amended as follows: Delete and replace the title and the mission and function statements for the Division of Scientific Resources (CVLH) and insert the following: Division of Scientific Resources (CVLH). The Division of Scientific Resources (DSR) provides products, services, and specialized expertise to CDC staff and activities in support of research and service activities: In carrying out its mission, DSR: (1) Provides animals, laboratory supplies, animal and human blood products, glassware, mammalian tissue cultures, microbiological media, special reagents, and other laboratory materials in support of research and service activities to laboratories and investigators at CDC; (2) develops and implements applied research programs to expand and enhance the use of animal models necessary to support research and diagnostic programs and to improve breeding and husbandry procedures; (3) conducts applied research in cell biology and in the expansion of tissue culture technology as a research and diagnostic tool for infectious disease activities; (4) provides services for laboratory investigators in protein and DNA synthesis and sequencing, genomic sequencing, microarrays, proteomics, and molecular modeling; (5) maintains a bank of serum and other biological specimens of epidemiological and special significance to CDC's research and diagnostic activities; (6) obtains and distributes experimental and orphaned vaccines, drugs, antisera, antitoxins, and immune globulins; (7) manages and distributes the inventory, maintains the computerized system database, and provides general technical service support for the dispensing, lyophilizing, capping, and labeling of CDC reference reagents; (8) receives, triages, processes, and distributes specimens to CDC laboratories for reference diagnostic testing, research studies, and epidemics and reports diagnostic test results to submitting organizations; (9) manages all CDC exports and ensures compliance with regulations and serves as CDC liaison with the Department of Commerce for export related issues; (10) produces and distributes specialized reagents and kits for the detection of select agents to members of the Laboratory Response Network; (11) provides services and expertise in development of quality systems to support compliance with the Food and Drug Administration regulations on production, distribution, and use of laboratory diagnostic reagents; (12) provides liaison activities, resources, and expertise for inquiries related to animals and zoonotic diseases; and (13) provides a centralized activity for tracking requests for and distributing select agents to investigators outside of CDC in compliance with federal regulations. Office of the Director (CVLH1). (1) Manages, directs, and coordinates the activities of DSR; (2) provides leadership and guidance on policy, budget, program planning and development, program management, and operations; (3) provides DSR-wide administrative and program services and coordinates or ensures coordination with the appropriate CIOs, OID, and CDC staff offices on administrative and program matters; (4) provides liaison with other governmental agencies, international organizations, and other outside groups; (5) coordinates, in collaboration with the appropriate CIOs, OID, and CDC components, laboratory activities relating to support of outbreak investigations or laboratory-based research including but not limited to specimen management, biological reagents, and laboratory supplies; (6) maintains a formulary of investigational and licensed drugs and biologicals that are distributed to approved physicians for the prevention, control, and/or treatment of rare, tropical, or exceptional diseases; (7) advises the Director, NCEZID, on policy matters concerning DSR activities; and (8) coordinates technical services for laboratory activities of CDC programs including procurement of glassware and laboratory supplies. Comparative Medicine Branch (CVLHB). (1) Acquires and distributes laboratory animals for research; (2) provides appropriate housing, husbandry, and psychological enrichment for all research animals; (3) provides veterinary services, including clinical and surgical support, for the laboratory animals; (4) develops standard operating procedures for animal care and use in accordance with the policies established by the American Association for Accreditation of Laboratory Animal Care, the Animal Welfare Act, The Guide for the Care & Use of Laboratory Animals, and the CDC International Animal Care & Use Committee; (5) conducts applied research to improve the care and use of animals in research and collaborates on research projects that use laboratory animals; (6) provides consultation and laboratory animal technology training to investigators, technical staff and animal care personnel; (7) provides oversight, support and investigator training for the graphical animal information technology protocol development and animal tracking database; (8) coordinates technical services for laboratory activities of CDC programs including processing and distribution of glassware and related items, laboratory waste decontamination and disposal, laundry services, and materiel management; and (9) provides autoclave label production services. Biotechnology Core Facility Branch (CVLHD). (1) provides state-of- the-art next-generation genomic sequencing and metagenomics analysis of infectious and biothreat agents; (2) provides optical mapping to produce high resolution whole-genome maps for strain typing, molecular epidemiology, comparative genomics, and quality control for whole genome sequence assembly; (3) provides computational analysis of genomics sequencing data, bioinformatics, and biological computing; (4) provides qualitative and quantitative proteomic analyses (identification of expressed proteins by mass spectrometry); analysis of functionally-relevant post-translational modifications of proteins; (5) provides mass spectrometry-based positive identification of bacteria and fungi (BioTyperTM, Bruker Daltonics); (6) provides synthetic oligonucleotide chemistry in support of development of rapid diagnostic tests and characterization of pathogens and their hosts; (7) provides synthetic peptide chemistry in support of studies of immune response and antigen-antibody interactions; (8) provides biotechnology seminars and methods evaluation; (9) provides laboratory equipment design and repair services to all CDC; and (10) collaborates on research related to STD transmitted infections as chronic infectious diseases. Reagent and Diagnostic Services Branch (CVLHG). (1) maintains laboratory water treatment systems to ensure quality of CDC reagent grade laboratory water; (2) produces, develops, evaluates and distributes custom microbiological and cell culture media, buffers and chemical reagent, mammalian and insect cell cultures, hybridomas, monoclonal and polycolonal antibodies, and in vitro diagnostic products for diagnostic research purposes, proficiency testing, pandemic preparedness, outbreak response and surveillance activities; (3) collaborates with subject matter experts [[Page 70425]] in regulatory compliant development, production, packaging, storing and distribution of BSL2/BSL3 reagents, select agents, novel immuno- chemical reagents and reference diagnostic reagents; (4) provides dispensing, lyophilizing, label production, and device assembly services; (5) improves the process of bench-top development and in- house pilot scale production providing immediate availability for distribution, preventing backorders and streamlining commercialization; (6) maintains CDC's Biological Reference Reagent Inventory, mammalian cell line repository and a serviceable inventory at the DSR Continuity of Operations storage facility; (7) provides centralized specimen management services for diagnostic, reference, and outbreak investigations; maintains a bank of biological specimens of epidemiological significance to CDC's research and diagnostic activities; manages and tracks systems of specimen collections; (8) receives, triages, processes, stores and distributes specimens to CDC laboratories for reference diagnostic testing, research studies, and reports diagnostic and surveillance test results to submitting organizations; (9) serves as central facility for acquisition and distribution of fresh human blood, blood products, and serum in bulk; (10) packages and ships infectious substances and other materials, ensuring compliance with regulations for shipping clinical specimens, infectious substances, and other materials; (11) manages all CDC exports and ensures compliance with regulations and serves as CDC liaison with Department of Commerce for export related issues; and (12) provides consultation in all of the above technical services. Sherri Berger, Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2016-24640 Filed 10-11-16; 8:45 am] BILLING CODE 4160-18-P
![Federal Register / Vol. 81, No. 197 / Wednesday, October 12, 2016 / Notices 70423
C. Public Comments DATES: Submit comments on or before number of units (FAR 27.202–5, 52.227–
Public comments are particularly November 14, 2016. 6, and 52.227–9).
invited on: Whether this collection of ADDRESSES: Submit comments regarding
B. Annual Reporting Burden
information is necessary for the proper this burden estimate or any other aspect
performance of functions of the FAR, of this collection of information, Number of Respondents: 107.
and whether it will have practical including suggestions for reducing this Responses per Respondent: 1.
burden to: Office of Information and Total Annual Responses: 107.
utility; whether our estimate of the
Regulatory Affairs of OMB, Attention: Hours per Response: 1.17.
public burden of this collection of
Desk Officer for GSA, Room 10236, Estimated Total Burden Hours: 126.
information is accurate, and based on
NEOB, Washington, DC 20503. Frequency: On Occasion.
valid assumptions and methodology; Affected Public: Businesses or other-
ways to enhance the quality, utility, and Additionally submit a copy to GSA by
any of the following methods: for-profit entities and not-for-profit
clarity of the information to be
• Regulations.gov: http:// institutions.
collected; and ways in which we can
minimize the burden of the collection of www.regulations.gov. Submit comments C. Public Comments
information on those who are to via the Federal eRulemaking portal by
searching for ‘‘9000–0096; Patents’’. Public comments are particularly
respond, through the use of appropriate invited on: Whether this collection of
technological collection techniques or Select the link ‘‘Submit a Comment’’
that corresponds with ‘‘Information information is necessary for the proper
other forms of information technology. performance of functions of the FAR,
Obtaining Copies of Proposals: Collection 9000–0096, Patents’’. Follow
the instructions provided at the ‘‘Submit and whether it will have practical
Requesters may obtain a copy of the
a Comment’’ screen. Please include your utility; whether our estimate of the
information collection documents from
name, company name (if any), and public burden of this collection of
the General Services Administration,
‘‘Information Collection 9000–0096, information is accurate, and based on
Regulatory Secretariat Division (MVCB),
Patents’’ on your attached document. valid assumptions and methodology;
1800 F Street NW., Washington, DC
• Mail: General Services ways to enhance the quality, utility, and
20405, telephone 202–501–4755. Please
cite OMB Control No. 9000–0138, Administration, Regulatory Secretariat clarity of the information to be
Contract Financing, in all Division (MVCB), IC 9000–0096, 1800 F collected; and ways in which we can
correspondence. Street NW., Washington, DC 20405. minimize the burden of the collection of
information on those who are to
Dated: October 5, 2016. Instructions: Please submit comments
respond, through the use of appropriate
Lorin S. Curit, only and cite Information Collection
technological collection techniques or
Director, Federal Acquisition Policy Division, 9000–0096, Patents, in all
other forms of information technology.
Office of Governmentwide Acquisition Policy, correspondence related to this
Obtaining Copies of Proposals:
Office of Acquisition Policy, Office of collection. Comments received generally
Requesters may obtain a copy of the
Governmentwide Policy. will be posted without change to http://
information collection documents from
[FR Doc. 2016–24538 Filed 10–11–16; 8:45 am] www.regulations.gov, including any
the General Services Administration,
BILLING CODE 6820–EP–P personal and/or business confidential
Regulatory Secretariat Division (MVCB),
information provided. To confirm
1800 F Street NW., Washington, DC
receipt of your comment(s), please
20405, telephone 202–501–4755.
DEPARTMENT OF DEFENSE check www.regulations.gov,
Please cite OMB Control No. 9000–
approximately two to three days after
GENERAL SERVICES 0096, Patents, in all correspondence.
submission to verify posting (except
ADMINISTRATION allow 30 days for posting of comments Dated: October 5, 2016.
submitted by mail). Lorin S. Curit,
NATIONAL AERONAUTICS AND FOR FURTHER INFORMATION CONTACT: Mr. Director, Federal Acquisition Policy Division,
SPACE ADMINISTRATION Charles Gray, Procurement Analyst, Office of Governmentwide Acquisition Policy,
Federal Acquisition Policy Division, at Office of Acquisition Policy, Office of
[OMB Control No. 9000–0096; Docket No.
Governmentwide Policy.
2016–0053; Sequence No. 31] 703–795–6328 or email charles.gray@
gsa.gov. [FR Doc. 2016–24537 Filed 10–11–16; 8:45 am]
Submission for OMB Review; Patents BILLING CODE 6820–14–P
SUPPLEMENTARY INFORMATION:
AGENCY: Department of Defense (DOD),
A. Purpose
General Services Administration (GSA),
and National Aeronautics and Space The patent coverage in Federal DEPARTMENT OF HEALTH AND
Administration (NASA). Acquisition Regulation (FAR) subpart HUMAN SERVICES
ACTION: Notice of request for comments 27.2 requires the contractor to report
Centers for Disease Control and
regarding an extension to an existing each notice of a claim of patent or
Prevention
OMB clearance. copyright infringement that came to the
contractor’s attention in connection Statement of Organization, Functions,
SUMMARY: Under the provisions of the with performing a Government contract and Delegations of Authority
Paperwork Reduction Act, the (FAR 27.202–1 and 52.227–2).
Regulatory Secretariat Division will be The contractor is also required to Part C (Centers for Disease Control
submitting to the Office of Management report all royalties anticipated or paid in and Prevention) of the Statement of
mstockstill on DSK3G9T082PROD with NOTICES
and Budget (OMB) a request to review excess of $250 for the use of patented Organization, Functions, and
and approve an extension of a inventions by furnishing the name and Delegations of Authority of the
previously approved information address of licensor, date of license Department of Health and Human
collection requirement concerning agreement, patent number, brief Services (45 FR 67772–76, dated
patents. A notice was published in the description of item or component, October 14, 1980, and corrected at 45 FR
Federal Register at 81 FR 43607 on July percentage or dollar rate of royalty per 69296, October 20, 1980, as amended
5, 2016. No comments were received. unit, unit price of contract item, and most recently at 81 FR 66284–66285,
VerDate Sep<11>2014 20:13 Oct 11, 2016 Jkt 241001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\12OCN1.SGM 12OCN1](https://thefederalregister.org/doc/81_FR_70620/page/1.svg)
![Federal Register / Vol. 81, No. 197 / Wednesday, October 12, 2016 / Notices 70425
in regulatory compliant development, compliance with regulations for will enter into force for the United
production, packaging, storing and shipping clinical specimens, infectious States. This Convention contains
distribution of BSL2/BSL3 reagents, substances, and other materials; (11) groundbreaking provisions that, for the
select agents, novel immuno-chemical manages all CDC exports and ensures first time on a worldwide scale, will
reagents and reference diagnostic compliance with regulations and serves establish uniform, simple, fast, and
reagents; (4) provides dispensing, as CDC liaison with Department of inexpensive procedures for the
lyophilizing, label production, and Commerce for export related issues; and processing of international child
device assembly services; (5) improves (12) provides consultation in all of the support cases. Once the Convention is
the process of bench-top development above technical services. in effect, U.S. states will process child
and in-house pilot scale production support cases with other countries that
Sherri Berger,
providing immediate availability for have ratified the Convention under the
distribution, preventing backorders and Chief Operating Officer, Centers for Disease requirements of the Convention and
Control and Prevention.
streamlining commercialization; (6) article 7 of the Uniform Interstate
[FR Doc. 2016–24640 Filed 10–11–16; 8:45 am]
maintains CDC’s Biological Reference Family Support Act (UIFSA 2008). In
Reagent Inventory, mammalian cell line BILLING CODE 4160–18–P order to comply with the Convention,
repository and a serviceable inventory at the U.S. must implement the
the DSR Continuity of Operations Convention’s case processing forms.
DEPARTMENT OF HEALTH AND
storage facility; (7) provides centralized State and Federal law require states to
HUMAN SERVICES
specimen management services for use federally-approved case processing
diagnostic, reference, and outbreak Administration for Children and forms. Section 311(b) of UIFSA 2008,
investigations; maintains a bank of Families which has been enacted by all 50 states,
biological specimens of epidemiological the District of Columbia, Guam, Puerto
significance to CDC’s research and Agency Recordkeeping/Reporting Rico and the Virgin Islands, requires
diagnostic activities; manages and tracks Requirements Under Emergency States to use forms mandated by Federal
systems of specimen collections; (8) Review by the Office of Management law. 45 CFR 303.7 also requires child
receives, triages, processes, stores and and Budget (OMB) support programs to use federally-
distributes specimens to CDC approved forms in intergovernmental
laboratories for reference diagnostic Title: Provision of Child Support IV–D cases unless a country has
testing, research studies, and reports Services in IV–D cases under the Hague provided alternative forms as a part of
diagnostic and surveillance test results Child Support Convention; Federally its chapter in a Caseworker’s Guide to
to submitting organizations; (9) serves as Approved Forms. Processing Cases with Foreign
central facility for acquisition and OMB No.: New Collection. Reciprocating Countries.
distribution of fresh human blood, Description: On January 1, 2017, the Respondents: State agencies
blood products, and serum in bulk; (10) 2007 Hague Convention on the administering a child support program
packages and ships infectious International Recovery of Child Support under title IV–D of the Social Security
substances and other materials, ensuring and Other Forms of Family Maintenance Act.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
Annex I: Transmittal form under Article 12(2) ................................................. 54 46 1 2,484
Annex II: Acknowledgment form under Article 12(3) ....................................... 54 93 .5 2,511
Annex A: Application for Recognition and Enforcement, including restricted
information on the applicant ......................................................................... 54 19 .5 513
Annex A: Abstract of Decision ......................................................................... 54 5 1 270
Annex A: Statement of Enforceability of Decision ........................................... 54 19 0.17 174
Annex A: Statement of Proper Notice ............................................................. 54 5 .5 135
Annex A: Status of Application Report ............................................................ 54 37 .33 659
Annex B: Application for Enforcement of a Decision Made or Recognized in
the Requested State, including restricted information on the applicant ...... 54 19 .5 513
Annex B: Status of Application Report, Article 12 ........................................... 54 37 .33 659
Annex C: Application for Establishment of a Decision, including restricted
information on the Applicant ........................................................................ 54 5 .5 135
Annex C: Status of Application Report—Article 12 ......................................... 54 9 .33 160
Annex D: Application for Modification of a Decision, including Restricted In-
formation on the Applicant ........................................................................... 54 5 .5 135
Annex D: Status of Application Report—Article 12 ......................................... 54 9 .33 160
Annex E: Financial Circumstances Form ........................................................ 54 46 2 4,968
mstockstill on DSK3G9T082PROD with NOTICES
Estimated Total Annual Burden of this information collection, with Comments and questions about the
Hours: 13,478. applicable supporting documentation, information collection described above
Additional Information: ACF is may be obtained by calling the should be directed to the Office of
requesting that OMB grant a 180 day Administration for Children and Information and Regulatory Affairs,
approval for this information collection Families, Reports Clearance Officer, Attn: OMB Desk Officer for ACF, Office
under procedures for emergency Robert Sargis at (202) 690–7275. of Management and Budget, Paperwork
processing by October 20, 2016. A copy Reduction Project, 725 17th Street NW.,
VerDate Sep<11>2014 20:13 Oct 11, 2016 Jkt 241001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\12OCN1.SGM 12OCN1](https://thefederalregister.org/doc/81_FR_70620/page/3.svg)
Document Created: 2016-10-12 00:55:41
Document Modified: 2016-10-12 00:55:41
| 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 | 81 FR 70423 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR