83_FR_7228 83 FR 7194 - Statement of Organization, Functions, and Delegations of Authority

83 FR 7194 - Statement of Organization, Functions, and Delegations of Authority

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 34 (February 20, 2018)

Page Range7194-7195
FR Document2018-03402

The Food and Drug Administration (FDA), Office of Global Regulatory Operations and Policy, Office of Regulatory Affairs (ORA), Office of Regulatory Science (ORS), and all ORA Laboratories have modified the structure. This new organizational structure was approved by the Secretary of Health and Human Services and effective on June 6, 2016.

Federal Register, Volume 83 Issue 34 (Tuesday, February 20, 2018) 
[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Notices]
[Pages 7194-7195]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03402]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-XXXX]


Statement of Organization, Functions, and Delegations of 
Authority

AGENCY: Office of Regulatory Affairs, Office of Global Regulatory 
Operations and Policy, Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA), Office of Global 
Regulatory Operations and Policy, Office of Regulatory Affairs (ORA), 
Office of Regulatory Science (ORS), and all ORA Laboratories have 
modified the structure. This new organizational structure was approved 
by the Secretary of Health and Human Services and effective on June 6, 
2016.

FOR FURTHER INFORMATION CONTACT: Paul Norris, DVM, MPA, Director, 
Office of Regulatory Science, Office of Regulatory Affairs, Office of 
Global Regulatory Operations and Policy, Food and Drug Administration, 
NCTR-50 Room 404, Jefferson, Arkansas 72079, Phone: 870-543-4099.

I. Summary

    Part D, Chapter D-B (Food and Drug Administration), the Statement 
of Organization, Functions, and Delegations of Authority for the 
Department of Health and Human Services 35 FR 3685, dated February 25, 
1970; 60 FR 56605, dated November 9, 1995; 64 FR 36361, dated July 6, 
1999; 72 FR 50112, dated August 30, 2007; 74 FR 41713, dated August 18, 
2009; and 76 FR 45270, dated July 28, 2011, is amended to reflect the 
reorganization of the Office of Regulatory Affairs and the Office of 
Regulatory Science (ORS), and all ORA Laboratories in this 
consolidation.
    This organization expands current activities in the Office of 
Regulatory Science and ORA's Laboratories in support of the Agency's 
Program Alignment Initiative. One of the key elements outlined in the 
initiative is to transition to distinct commodity-based and vertically 
integrated regulatory programs with well-defined leads, promoting 
coherent policy and strategic development. This transforms the 
regionally organized laboratory system into a true national resource 
with enhanced ability to meet its public health mission to provide 
diverse scientific expertise, leadership, and responsive quality 
analytical services to safeguard public health in a global environment 
and foster continued flexibility across its functions and programs. It 
also centralizes and streamlines laboratory operations, scientific 
research, and support functions into one Office of Regulatory Science. 
Operationally this facilitates a more efficient and strategic 
deployment of these resources during public health emergencies and food 
borne outbreaks. Centralizing the laboratory system greatly enhances 
command and control of laboratory functions.
    The Food and Drug Administration, Office of Global Regulatory 
Operations and Policy, Office of Regulatory Affairs (ORA), Office of 
Regulatory Science (ORS) has been restructured as follows:

    DLLRK. ORGANIZATION. The Office of Regulatory Science is headed 
by the Director, Office of Regulatory Science and includes the 
following organizational units:

Office of Regulatory Science (DLLRK)
Automated Laboratory Management Staff (DLLRK1)
Safety and Risk Management Staff (DLLRK2)
Office of Research Coordination and Evaluation (DLLRKA)
Scientific Research Staff (DLLRKA1)
Evaluation Staff (DLLRKA2)
Office of Medical Products, Tobacco, and Specialty Laboratory 
Operations (DLLRKB)
Medical Products and Tobacco Scientific Staff (DLLRKB1)
Forensic Chemistry Center (DLLRKBA)
Inorganic Branch (DLLRKBA1)
Organic Branch (DLLRKBA2)
Winchester Engineering and Analytical Center (DLLRKBB)
Analytical Branch (DLLRKBB1)
Engineering Branch (DLLRKBB2)
Detroit Laboratory (DLLRKBC)
Northeast Medical Products Laboratory (DLLRKBD)
Pacific Southwest Medical Products Laboratory (DLLRKBE)
Philadelphia Laboratory (DLLRKBF)
San Juan Laboratory (DLLRKBG)
Southeast Tobacco Laboratory (DLLRKBH)
Office of Food and Feed Laboratory Operations (DLLRKC)
Food and Feed Scientific Staff (DLLRKC1)
Arkansas Laboratory (DLLRKCA)
Chemistry Branch I (DLLRKCA1)
Chemistry Branch II (DLLRKCA2)
Microbiology Branch (DLLRKCA3)
Denver Laboratory (DLLRKCB)
Chemistry Branch (DLLRKCB1)
Microbiology Branch (DLLRKCB2)
Kansas City Laboratory (DLLRKCC)
Chemistry Branch I (DLLRKCC1)
Chemistry Branch II (DLLRKCC2)
Northeast Food and Feed Laboratory (DLLRKCD)
Chemistry Branch I (DLLRKCD1)
Chemistry Branch II (DLLRKCD2)
Microbiology Sciences Branch (DLLRKCD3)
Pacific Northwest Laboratory (DLLRKCE)
Chemistry Branch (DLLRKCE1)
Microbiology Branch (DLLRKCE2)
Applied Technology Branch (DLLRKCE3)
San Francisco Laboratory (DLLRKCF)
Chemistry Branch (DLLRKCF1)
Microbiology Branch (DLLRKCF2)
Southeast Food and Feed Laboratory (DLLRKCG)
Microbiology Branch (DLLRKCG1)
Nutrient Analysis Branch (DLLRKCG2)
Chemistry Branch (DLLRKCG3)
Pacific Southwest Food and Feed Laboratory (DLLRKCH)
Chemistry Branch (DLLRKCH1)
Microbiology Branch (DLLRKCH2)

[[Page 7195]]

II. Delegations of Authority

    Pending further delegation, directives, or orders by the 
Commissioner of Food and Drugs, all delegations and redelegations of 
authority made to officials and employees of affected organizational 
components will continue in them or their successors pending further 
redelegations, provided they are consistent with this reorganization.

III. Electronic Access

    Persons interested in seeing the complete Staff Manual Guide can 
find it on FDA's website at: http://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm.

    Dated: December 21, 2017.
Eric D. Hargan
Acting Secretary of Health and Human Services.
[FR Doc. 2018-03402 Filed 2-16-18; 8:45 am]
 BILLING CODE P

7194 Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices biologics license application (BLA) for and Policy, Food and Drug greatly enhances command and control DARZALEX (BLA 761,036) was initially Administration, HHS. of laboratory functions. submitted on July 9, 2015. ACTION: Notice. The Food and Drug Administration, 3. The date the application was Office of Global Regulatory Operations approved: November 16, 2015. FDA has SUMMARY: The Food and Drug Administration (FDA), Office of Global and Policy, Office of Regulatory Affairs verified the applicant’s claim that BLA (ORA), Office of Regulatory Science 761,036 was approved on November 16, Regulatory Operations and Policy, Office of Regulatory Affairs (ORA), (ORS) has been restructured as follows: 2015. This determination of the regulatory Office of Regulatory Science (ORS), and DLLRK. ORGANIZATION. The Office of review period establishes the maximum all ORA Laboratories have modified the Regulatory Science is headed by the Director, potential length of a patent extension. structure. This new organizational Office of Regulatory Science and includes the However, the USPTO applies several structure was approved by the Secretary following organizational units: statutory limitations in its calculations of Health and Human Services and Office of Regulatory Science (DLLRK) of the actual period for patent extension. effective on June 6, 2016. Automated Laboratory Management Staff In its application for patent extension, FOR FURTHER INFORMATION CONTACT: Paul (DLLRK1) this applicant seeks 1,000 days of patent Norris, DVM, MPA, Director, Office of Safety and Risk Management Staff (DLLRK2) Office of Research Coordination and term extension. Regulatory Science, Office of Regulatory Evaluation (DLLRKA) III. Petitions Affairs, Office of Global Regulatory Scientific Research Staff (DLLRKA1) Operations and Policy, Food and Drug Evaluation Staff (DLLRKA2) Anyone with knowledge that any of Administration, NCTR–50 Room 404, Office of Medical Products, Tobacco, and the dates as published are incorrect may Jefferson, Arkansas 72079, Phone: 870– Specialty Laboratory Operations (DLLRKB) submit either electronic or written 543–4099. Medical Products and Tobacco Scientific comments and, under 21 CFR 60.24, ask Staff (DLLRKB1) for a redetermination (see DATES). I. Summary Forensic Chemistry Center (DLLRKBA) Furthermore, as specified in § 60.30 (21 Part D, Chapter D–B (Food and Drug Inorganic Branch (DLLRKBA1) CFR 60.30), any interested person may Administration), the Statement of Organic Branch (DLLRKBA2) petition FDA for a determination Organization, Functions, and Winchester Engineering and Analytical regarding whether the applicant for Delegations of Authority for the Center (DLLRKBB) extension acted with due diligence Department of Health and Human Analytical Branch (DLLRKBB1) during the regulatory review period. To Services 35 FR 3685, dated February 25, Engineering Branch (DLLRKBB2) meet its burden, the petition must 1970; 60 FR 56605, dated November 9, Detroit Laboratory (DLLRKBC) comply with all the requirements of 1995; 64 FR 36361, dated July 6, 1999; Northeast Medical Products Laboratory § 60.30, including but not limited to: 72 FR 50112, dated August 30, 2007; 74 (DLLRKBD) must be timely (see DATES), must be FR 41713, dated August 18, 2009; and Pacific Southwest Medical Products filed in accordance with § 10.20, must Laboratory (DLLRKBE) 76 FR 45270, dated July 28, 2011, is Philadelphia Laboratory (DLLRKBF) contain sufficient facts to merit an FDA amended to reflect the reorganization of San Juan Laboratory (DLLRKBG) investigation, and must certify that a the Office of Regulatory Affairs and the Southeast Tobacco Laboratory (DLLRKBH) true and complete copy of the petition Office of Regulatory Science (ORS), and Office of Food and Feed Laboratory has been served upon the patent all ORA Laboratories in this Operations (DLLRKC) applicant. (See H. Rept. 857, part 1, 98th consolidation. Food and Feed Scientific Staff (DLLRKC1) Cong., 2d sess., pp. 41–42, 1984.) This organization expands current Arkansas Laboratory (DLLRKCA) Petitions should be in the format activities in the Office of Regulatory Chemistry Branch I (DLLRKCA1) specified in 21 CFR 10.30. Science and ORA’s Laboratories in Chemistry Branch II (DLLRKCA2) Submit petitions electronically to support of the Agency’s Program Microbiology Branch (DLLRKCA3) https://www.regulations.gov at Docket Alignment Initiative. One of the key Denver Laboratory (DLLRKCB) No. FDA–2013–S–0610. Submit written elements outlined in the initiative is to Chemistry Branch (DLLRKCB1) petitions (two copies are required) to the transition to distinct commodity-based Microbiology Branch (DLLRKCB2) Dockets Management Staff (HFA–305), and vertically integrated regulatory Kansas City Laboratory (DLLRKCC) Food and Drug Administration, 5630 programs with well-defined leads, Chemistry Branch I (DLLRKCC1) Fishers Lane, Rm. 1061, Rockville, MD promoting coherent policy and strategic Chemistry Branch II (DLLRKCC2) Northeast Food and Feed Laboratory 20852. development. This transforms the (DLLRKCD) Dated: February 13, 2018. regionally organized laboratory system Chemistry Branch I (DLLRKCD1) Leslie Kux, into a true national resource with Chemistry Branch II (DLLRKCD2) enhanced ability to meet its public Microbiology Sciences Branch (DLLRKCD3) Associate Commissioner for Policy. health mission to provide diverse Pacific Northwest Laboratory (DLLRKCE) [FR Doc. 2018–03342 Filed 2–16–18; 8:45 am] scientific expertise, leadership, and Chemistry Branch (DLLRKCE1) BILLING CODE 4164–01–P responsive quality analytical services to Microbiology Branch (DLLRKCE2) safeguard public health in a global Applied Technology Branch (DLLRKCE3) environment and foster continued San Francisco Laboratory (DLLRKCF) DEPARTMENT OF HEALTH AND Chemistry Branch (DLLRKCF1) flexibility across its functions and HUMAN SERVICES Microbiology Branch (DLLRKCF2) programs. It also centralizes and streamlines laboratory operations, Southeast Food and Feed Laboratory sradovich on DSK3GMQ082PROD with NOTICES Food and Drug Administration (DLLRKCG) scientific research, and support [Docket No. FDA–2017–N–XXXX] Microbiology Branch (DLLRKCG1) functions into one Office of Regulatory Nutrient Analysis Branch (DLLRKCG2) Science. Operationally this facilitates a Chemistry Branch (DLLRKCG3) Statement of Organization, Functions, more efficient and strategic deployment Pacific Southwest Food and Feed Laboratory and Delegations of Authority of these resources during public health (DLLRKCH) AGENCY: Office of Regulatory Affairs, emergencies and food borne outbreaks. Chemistry Branch (DLLRKCH1) Office of Global Regulatory Operations Centralizing the laboratory system Microbiology Branch (DLLRKCH2) VerDate Sep<11>2014 17:55 Feb 16, 2018 Jkt 244001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\20FEN1.SGM 20FEN1

Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices 7195 II. Delegations of Authority that a proposed collection of designed to ease restrictions on Pending further delegation, directives, information has been submitted to the exportation of unapproved or orders by the Commissioner of Food Office of Management and Budget pharmaceuticals, biologics, and devices and Drugs, all delegations and (OMB) for review and clearance under regulated by FDA. Section 801(e)(4) of redelegations of authority made to the Paperwork Reduction Act of 1995. FDAERA provides that persons officials and employees of affected DATES: Fax written comments on the exporting certain FDA-regulated organizational components will collection of information by March 22, products may request FDA to certify continue in them or their successors 2018. that the products meet the requirements pending further redelegations, provided ADDRESSES: To ensure that comments on of sections 801(e) and 802 or other they are consistent with this the information collection are received, requirements of the FD&C Act. This reorganization. OMB recommends that written section of the law requires FDA to issue comments be faxed to the Office of certification within 20 days of receipt of III. Electronic Access Information and Regulatory Affairs, the request and to charge firms up to Persons interested in seeing the OMB, Attn: FDA Desk Officer, Fax: 202– $175 for the certifications. In January complete Staff Manual Guide can find it 395–7285, or emailed to oira_ 2011, section 801(e)(4)(A) was amended on FDA’s website at: http:// submission@omb.eop.gov. All by the FDA Food Safety Modernization www.fda.gov/AboutFDA/Reports comments should be identified with the Act (Pub. L. 111–353) to provide ManualsForms/StaffManualGuides/ OMB control number 0910–0498. Also authorization for export certification default.htm. include the FDA docket number found fees for food and animal feed. Dated: December 21, 2017. in brackets in the heading of this document. This section of the FD&C Act Eric D. Hargan authorizes FDA to issue export Acting Secretary of Health and Human FOR FURTHER INFORMATION CONTACT: certificates for regulated food, animal Services. Amber Sanford, Office of Operations, feed, pharmaceuticals, biologics, and [FR Doc. 2018–03402 Filed 2–16–18; 8:45 am] Food and Drug Administration, Three devices that are legally marketed in the BILLING CODE P White Flint North, 10A–12M, 11601 United States, as well as for these same Landsdown St., North Bethesda, MD products that are not legally marketed 20852, 301–796–8867, PRAStaff@ but are acceptable to the importing DEPARTMENT OF HEALTH AND fda.hhs.gov. country, as specified in sections 801(e) HUMAN SERVICES SUPPLEMENTARY INFORMATION: In and 802 of the FD&C Act. FDA has compliance with 44 U.S.C. 3507, FDA developed various types of certificates Food and Drug Administration has submitted the following proposed that satisfy the requirements of section [Docket No. FDA–2010–N–0161] collection of information to OMB for 801(e)(4)(B) of the FD&C Act. Four of review and clearance. those certificates are discussed in this Agency Information Collection notice: (1) Certificates to Foreign Export of Food and Drug Activities; Submission for Office of Governments, (2) Certificates of Administration-Regulated Products: Management and Budget Review; Exportability, (3) Certificates of a Export Certificates Comment Request; Export of Food and Pharmaceutical Product, and (4) Non- Drug Administration-Regulated OMB Control Number 0910–0498— Clinical Research Use Only Certificates. Products: Export Certificates Extension FDA has updated the certificates as part AGENCY: Food and Drug Administration, In April 1996, the FDA Export, of the proposed collection of HHS. Reform, and Enhancement Act of 1996 information to account for the ACTION: Notice. (FDAERA) (Pub. L. 104–134) amended amendment authorizing export sections 801(e) and 802 of the Federal certification fees for food and animal SUMMARY: The Food and Drug Food, Drug, and Cosmetic Act (FD&C feed. Table 1 lists the different Administration (FDA) is announcing Act) (21 U.S.C. 381(e) and 382). It was certificates and details their uses: TABLE 1—CERTIFICATES AND USES Type of certificate Use ‘‘Supplementary Information Certificate to Foreign Government Re- For the export of products legally marketed in the United States. quests’’. ‘‘Exporter’s Certification Statement Certificate to Foreign Government’’ ‘‘Exporter’s Certification Statement Certificate to Foreign Government (For Human Tissue Intended for Transplantation)’’. ‘‘Supplementary Information Certificate of Exportability Requests’’ ........ For the export of products not approved for marketing in the United ‘‘Exporter’s Certification Statement Certificate of Exportability’’ States (unapproved products) that meet the requirements of sections 801(e) or 802 of the FD&C Act. ‘‘Supplementary Information Certificate of a Pharmaceutical Product’’ ... Conforms to the format established by the World Health Organization ‘‘Exporter’s Certification Statement Certificate of a Pharmaceutical and is intended for use by the importing country when the product in Product’’. question is under consideration for a product license that will author- sradovich on DSK3GMQ082PROD with NOTICES ize its importation and sale or for renewal, extension, amending, or reviewing a license. ‘‘Supplementary Information Non-Clinical Research Use Only Certifi- For the export of a non-clinical research use only product, material, or cate’’. component that is not intended for human use which may be mar- ‘‘Exporter’s Certification Statement (Non-Clinical Research Use Only)’’ keted in, and legally exported from the United States under the FD&C Act. VerDate Sep<11>2014 17:55 Feb 16, 2018 Jkt 244001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\20FEN1.SGM 20FEN1


Document Created: 2018-02-17 02:29:14
Document Modified: 2018-02-17 02:29:14
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactPaul Norris, DVM, MPA, Director, Office of Regulatory Science, Office of Regulatory Affairs, Office of Global Regulatory Operations and Policy, Food and Drug Administration, NCTR-50 Room 404, Jefferson, Arkansas 72079, Phone: 870-543-4099.
FR Citation83 FR 7194 
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