80 FR 18850 - Center for Devices and Radiological Health: Experiential Learning Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 67 (April 8, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 67 (April 8, 2015)
| Page Range | 18850-18852 | |
| FR Document | 2015-08017 |
[Federal Register Volume 80, Number 67 (Wednesday, April 8, 2015)] [Notices] [Pages 18850-18852] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-08017] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0986] Center for Devices and Radiological Health: Experiential Learning Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH or Center) is announcing the 2015 Experiential Learning Program (ELP). This training component is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle. The purpose of this document is to invite medical device industry, academia, and health care facilities to apply to participate in this formal training program for FDA's medical device review staff, or to contact CDRH for more information regarding the ELP. DATES: Submit either an electronic or written request for participation in the ELP by May 8, 2015. The proposal should include a description of your facility relative to focus areas described in tables 1or 2). Please include the Area of Interest (see tables 1or 2) that the site visit will demonstrate to CDRH staff, a contact person, site visit location(s), length of site visit, proposed dates, and maximum number of CDRH staff that can be accommodated during a site visit. Proposals submitted without this minimum information will not be considered. In addition, please include an agenda outlining the proposed training for the site visit. A sample request and agenda are available on the ELP Web site at http://www.fda.gov/downloads/ScienceResearch/ScienceCareerOpportunities/UCM392988.pdf and http://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm. ADDRESSES: Submit either electronic requests to http://www.regulations.gov or written requests to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify proposals with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Latonya Powell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5232, Silver Spring, MD 20993-0002, 301-796-6965, FAX: 301-827-3079, Latonya.powell@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background CDRH is responsible for ensuring the safety and effectiveness of medical devices marketed in the United States. Furthermore, CDRH assures that patients and providers have timely and continued access to high-quality, safe, and effective medical devices. In support of this mission, the Center launched various training and development initiatives to enhance performance of its staff involved in regulatory review and in the premarket review process. One of these initiatives, the ELP Pilot, was launched in 2012 and fully implemented on April 2, 2013 (78 FR 19711). CDRH is committed to advancing regulatory science; providing industry with predictable, consistent, transparent, and efficient regulatory pathways; and helping to ensure consumer confidence in medical devices marketed in the United States and throughout the world. The ELP is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle. This is a collaborative effort to enhance communication and facilitate the premarket review process. Furthermore, CDRH is committed to understanding current industry practices, innovative technologies, regulatory impacts, and regulatory needs. These formal training visits are not intended for FDA to inspect, assess, judge, or perform a regulatory function (e.g., compliance inspection), but rather, they are an opportunity to provide CDRH review staff a better understanding of the products they review. Through this notice, CDRH is formally requesting participation from companies, academia, and clinical facilities, including those that have previously participated in the ELP or other FDA site visit programs. II. ELP A. ELP Training Component In this training program, groups of CDRH staff will observe operations at research, manufacturing, academia, and health care facilities. The focus areas and specific areas of interest for visits may include the following: Table 1--Areas of Interest--Medical Devices/Technology ------------------------------------------------------------------------ Focus area Specific areas of interest ------------------------------------------------------------------------ Failure analysis of orthopedic Methods for retrieval and devices. preservation of failed implants for analysis; understanding how retrieved implants may be analyzed; methods for identifying failure modes; understanding how analysis of failed implants influences device design modifications. Radiologic analysis of orthopedic Methods of radiologic analysis and devices. associated data analyses; radiologic imaging core laboratories. Automated external defibrillators Manufacturing process; incoming (AEDs). component inspection; design verification testing; human factors testing; returned product testing (as available). Diagnostic imaging catheters for Manufacturing process; design cardiovascular diseases. verification testing; returned product testing (as available); ultrasound, optical coherence tomography (OCT), and near infrared spectroscopy (NIS) catheters. Endovascular grafts for treatment Physician-sponsored clinical of aortic aneurysms. studies; observation of endovascular grafting surgical procedure; surgical planning process; factors that influence device modifications (e.g., patient anatomy, patient pathology). Animal models for evaluation of Models of traumatic injury and hemostatic devices. severe hemorrhage; limitations of the model; understanding the relevance of the data generated from these models in evaluating hemostatic devices. Hyaluronic acid in dermal tissue Manufacturing process; source fillers. materials; performance testing (e.g., material characterization, biocompatibility, residence time). Minimally invasive glaucoma Observation of a MIGS procedure; surgery (MIGS) devices. surgical planning; surgical challenges. [[Page 18851]] Neurointerventional devices....... Stents, flow-diverters, mesh balls, coils, and other related devices; observation of surgical procedures; understanding of clinical decision making for relevant patient populations; manufacturing; performance testing. Implantable functional electrical Observation of implantation stimulation devices. procedure; surgical challenges. Male condoms...................... Manufacturing process; lot release testing (e.g., airburst, water leak, dimensional analysis). Solid organ preservation devices.. Observation of organ preservation procedures; pulsatile perfusion (for either cold storage or normothermia). Infusion pumps.................... Manufacturing process; device design considerations; patch pumps; insulin pumps; implantable infusion pumps; implantable ports. Bone grafting materials for dental Manufacturing process; sourcing applications. process; viral inactivation testing; animal testing. ------------------------------------------------------------------------ Table 2--Areas of Interest--In Vitro Diagnostic and Radiological Devices/ Technology ------------------------------------------------------------------------ Focus area Specific areas of interest ------------------------------------------------------------------------ Manufacturing of glucose test Observation of the manufacturing and strips and meters. in-process and finished device testing of glucose monitoring devices. Manufacturing of continuous Observation of the manufacturing and glucose monitoring systems and in-process and finished device insulin pumps. testing of glucose monitors and insulin pumps. Manufacturing of chemistry devices Observation of the manufacturing and in-process and finished device testing of point of care chemistry cassettes/cartridges/strips for smaller chemistry analyzers used in clinical and point of care settings. Manufacturing of chemistry Observation of the manufacturing and reagent, controls and calibrators. in-process and finished device testing of chemistry reagents, calibrators, and controls for common chemistry analytes used in a clinical laboratory setting. Manufacturing of urine test strips Manufacturing and observation of in and readers. process or finished device testing for urine test strips and meters in clinical laboratory and point of care testing settings. Manufacturing and development of Observation of manufacturing, in- IHC (immunohistochemistry) process testing, and/or finished devices. device testing of IHC devices (used in the diagnostic evaluation of cancer, classification of tumors, or companion diagnostic testing). Manufacturing and development of Observation of the manufacturing, in- ISH (in situ hybridization) process testing, or finished device devices. testing of colorimetric in situ hybridization (CISH) and/or fluorescent in situ hybridization (FISH) assays used in identifying specific nucleic acid sequences within tissue sections (for diagnostic and/or treatment decisions). Manufacturing and development of Observation of NGS sequencing NGS (next gen sequencing) platforms, bioinformatic analysis platforms and devices. of the resulting sequence information, and types of interpretative software for potential clinical purposes. Manufacturing, development and Observation of the manufacturing, in- observation of CTC (circulating process testing, or finished device tumor cells) devices. testing of CTC devices that assess the prognosis of patients with metastatic breast, colorectal, or prostate cancer (manufacturing site or research site or clinical setting). Manufacturing, development and/or Observe the manufacturing, observation of clinical mass development and/or demonstration of spectrometers and high clinical mass spectrometers and performance liquid chromatography HPLC as part of laboratory workflow (HPLC) devices. including sample preparation, equipment usage, and data analysis. Manufacturing, development and Manufacturing, research, and research of flow cytometry development of in-process testing, devices and components. or finished device testing of cytometry analyzers and accompanying components. Manufacturing of immunoassays for Manufacturing and development of in- autoimmune diseases. process testing, or finished device testing, for diagnostic evaluation and research. Manufacturing and development of Manufacturing and development of in- coagulation--point of care process or finished device testing devices. for point of care devices such as Prothrombin Time and International Normalized Ratio (PT/INR) meters. Manufacturing and product Manufacturing of global hemostasis development of global hemostasis testing for anti-coagulants and testing devices. anti-platelet drugs for new molecular targets to assess the level of drug-induced inhibition for qualitative and quantitative evaluation. Manufacturing and product Manufacturing and development of development of direct assays, controls, and calibrators anticoagulants assays/controls/ for the detection of direct calibrators. anticoagulants. Observation of testing of Visit a sequencing center where sequencing technologies in large various sequencing methods are used sequencing centers. for different applications other than in vitro diagnostic devices (IVD) manufacturing. Manufacturing, and product Visit a manufacturer of IVD designed evaluation of IVDs using next for sequencing of microorganisms generation sequencing (NGS) for identification purposes. technology. Clinical applications-NGS in Visit a clinical laboratory that practice. uses NGS as a diagnostic/screening tool. Antimicrobial susceptibility Visit to a manufacturer of testing (AST). antimicrobial susceptibility test platforms intended for use in clinical laboratory settings. [[Page 18852]] Antimicrobial susceptibility Visit to a clinical laboratory that testing (AST). employs various AST methodologies for identification of antibiotic resistance. ------------------------------------------------------------------------ B. Site Selection CDRH will be responsible for CDRH staff travel expenses associated with the site visits. CDRH will not provide funds to support the training provided by the site to this ELP. Selection of potential facilities will be based on CDRH's priorities for staff training and resources available to fund this program. In addition to logistical and other resource factors, all sites must have a successful compliance record with FDA or another Agency with which FDA has a memorandum of understanding. If a site visit involves a visit to a separate physical location of another firm under contract with the site, that firm must agree to participate in the ELP and must also have a satisfactory compliance history. III. Request for Participation Submit proposals for participation with the docket number found in the brackets in the heading of this document. Received requests may be seen in the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. Dated: April 2, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-08017 Filed 4-7-15; 8:45 am] BILLING CODE 4164-01-P
![18850 Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices
Leroy A. Richardson, contact person, site visit location(s), performance of its staff involved in
Chief, Information Collection Review Office, length of site visit, proposed dates, and regulatory review and in the premarket
Office of Scientific Integrity, Office of the maximum number of CDRH staff that review process. One of these initiatives,
Associate Director for Science, Office of the can be accommodated during a site the ELP Pilot, was launched in 2012 and
Director, Centers for Disease Control and visit. Proposals submitted without this fully implemented on April 2, 2013 (78
Prevention.
minimum information will not be FR 19711). CDRH is committed to
[FR Doc. 2015–08028 Filed 4–7–15; 8:45 am]
considered. In addition, please include advancing regulatory science; providing
BILLING CODE 4163–18–P an agenda outlining the proposed industry with predictable, consistent,
training for the site visit. A sample transparent, and efficient regulatory
request and agenda are available on the pathways; and helping to ensure
DEPARTMENT OF HEALTH AND
ELP Web site at http://www.fda.gov/ consumer confidence in medical
HUMAN SERVICES
downloads/ScienceResearch/ devices marketed in the United States
Food and Drug Administration ScienceCareerOpportunities/ and throughout the world. The ELP is
UCM392988.pdf and http:// intended to provide CDRH staff with an
[Docket No. FDA–2015–N–0986] www.fda.gov/scienceresearch/ opportunity to understand the policies,
sciencecareeropportunities/ laboratory practices, and challenges
Center for Devices and Radiological
ucm380676.htm. faced in broader disciplines that impact
Health: Experiential Learning Program
ADDRESSES: Submit either electronic the device development life cycle. This
AGENCY: Food and Drug Administration, requests to http://www.regulations.gov is a collaborative effort to enhance
HHS. or written requests to the Division of communication and facilitate the
ACTION: Notice. Dockets Management (HFA–305), Food premarket review process. Furthermore,
and Drug Administration, 5630 Fishers CDRH is committed to understanding
SUMMARY: The Food and Drug current industry practices, innovative
Administration (FDA), Center for Lane, Rm. 1061, Rockville, MD 20852.
Identify proposals with the docket technologies, regulatory impacts, and
Devices and Radiological Health (CDRH regulatory needs.
or Center) is announcing the 2015 number found in brackets in the
heading of this document. These formal training visits are not
Experiential Learning Program (ELP).
FOR FURTHER INFORMATION CONTACT: intended for FDA to inspect, assess,
This training component is intended to
Latonya Powell, Center for Devices and judge, or perform a regulatory function
provide CDRH staff with an opportunity
Radiological Health, Food and Drug (e.g., compliance inspection), but rather,
to understand the policies, laboratory
Administration, 10903 New Hampshire they are an opportunity to provide
practices, and challenges faced in
Ave., Bldg. 32, Rm. 5232, Silver Spring, CDRH review staff a better
broader disciplines that impact the
MD 20993–0002, 301–796–6965, FAX: understanding of the products they
device development life cycle. The
301–827–3079, Latonya.powell@ review. Through this notice, CDRH is
purpose of this document is to invite
fda.hhs.gov. formally requesting participation from
medical device industry, academia, and
companies, academia, and clinical
health care facilities to apply to SUPPLEMENTARY INFORMATION: facilities, including those that have
participate in this formal training
I. Background previously participated in the ELP or
program for FDA’s medical device
other FDA site visit programs.
review staff, or to contact CDRH for CDRH is responsible for ensuring the
more information regarding the ELP. safety and effectiveness of medical II. ELP
DATES: Submit either an electronic or devices marketed in the United States. A. ELP Training Component
written request for participation in the Furthermore, CDRH assures that
ELP by May 8, 2015. The proposal patients and providers have timely and In this training program, groups of
should include a description of your continued access to high-quality, safe, CDRH staff will observe operations at
facility relative to focus areas described and effective medical devices. In research, manufacturing, academia, and
in tables 1or 2). Please include the Area support of this mission, the Center health care facilities. The focus areas
of Interest (see tables 1or 2) that the site launched various training and and specific areas of interest for visits
visit will demonstrate to CDRH staff, a development initiatives to enhance may include the following:
TABLE 1—AREAS OF INTEREST—MEDICAL DEVICES/TECHNOLOGY
Focus area Specific areas of interest
Failure analysis of orthopedic de- Methods for retrieval and preservation of failed implants for analysis; understanding how retrieved implants
vices. may be analyzed; methods for identifying failure modes; understanding how analysis of failed implants
influences device design modifications.
Radiologic analysis of orthopedic Methods of radiologic analysis and associated data analyses; radiologic imaging core laboratories.
devices.
Automated external defibrillators Manufacturing process; incoming component inspection; design verification testing; human factors testing;
(AEDs). returned product testing (as available).
Diagnostic imaging catheters for Manufacturing process; design verification testing; returned product testing (as available); ultrasound, opti-
asabaliauskas on DSK5VPTVN1PROD with NOTICES
cardiovascular diseases. cal coherence tomography (OCT), and near infrared spectroscopy (NIS) catheters.
Endovascular grafts for treatment of Physician-sponsored clinical studies; observation of endovascular grafting surgical procedure; surgical
aortic aneurysms. planning process; factors that influence device modifications (e.g., patient anatomy, patient pathology).
Animal models for evaluation of he- Models of traumatic injury and severe hemorrhage; limitations of the model; understanding the relevance
mostatic devices. of the data generated from these models in evaluating hemostatic devices.
Hyaluronic acid in dermal tissue Manufacturing process; source materials; performance testing (e.g., material characterization, biocompat-
fillers. ibility, residence time).
Minimally invasive glaucoma sur- Observation of a MIGS procedure; surgical planning; surgical challenges.
gery (MIGS) devices.
VerDate Sep<11>2014 17:55 Apr 07, 2015 Jkt 235001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\08APN1.SGM 08APN1](https://thefederalregister.org/doc/80_FR_18917/page/1.svg)
![18852 Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices
TABLE 2—AREAS OF INTEREST—IN VITRO DIAGNOSTIC AND RADIOLOGICAL DEVICES/TECHNOLOGY—Continued
Focus area Specific areas of interest
Antimicrobial susceptibility testing Visit to a clinical laboratory that employs various AST methodologies for identification of antibiotic resist-
(AST). ance.
B. Site Selection Scientific Report of the 2015 Dietary Dated: March 24, 2015.
CDRH will be responsible for CDRH Guidelines Advisory Committee Don Wright,
staff travel expenses associated with the (Advisory Report) and to solicit written Deputy Assistant Secretary for Health, Office
site visits. CDRH will not provide funds comments on the Advisory Report of Disease Prevention and Health Promotion,
(among other things). In the notice dated Office of the Assistant Secretary for Health,
to support the training provided by the
U.S. Department of Health and Human
site to this ELP. Selection of potential February 23, 2015, it was announced
Services.
facilities will be based on CDRH’s that the due date for providing
Dated: March 24, 2015.
priorities for staff training and resources comments was April 8, 2015. This
available to fund this program. In Angela Tagtow,
notice is to announce the extension of
addition to logistical and other resource Executive Director, Center for Nutrition Policy
the solicitation period to allow for
factors, all sites must have a successful and Promotion, U.S. Department of
additional time for written comments to Agriculture.
compliance record with FDA or another be submitted for consideration.
Agency with which FDA has a Dated: March 23, 2015.
memorandum of understanding. If a site DATES: The comment period is extended Steven R. Shafer,
visit involves a visit to a separate and thus will end at 11:59 p.m., E.D.T. Associate Administrator, Agricultural
physical location of another firm under on May 8, 2015. Research Service, U.S. Department of
Agriculture.
contract with the site, that firm must ADDRESSES: The Advisory Report is
agree to participate in the ELP and must [FR Doc. 2015–08049 Filed 4–7–15; 8:45 am]
available on the Internet at
also have a satisfactory compliance www.DietaryGuidelines.gov. Written
BILLING CODE 4150–32–P
history.
public comments on the Advisory
III. Request for Participation Report can be submitted and/or viewed DEPARTMENT OF HEALTH AND
Submit proposals for participation at www.DietaryGuidelines.gov using the HUMAN SERVICES
with the docket number found in the ‘‘Submit Comments’’ and ‘‘Read
brackets in the heading of this Comments’’ links, respectively. National Institutes of Health
document. Received requests may be FOR FURTHER INFORMATION CONTACT: Office of the Director, Office of Science
seen in the Division of Dockets Designated Federal Officer (DFO), 2015 Policy, Office of Biotechnology
Management (see ADDRESSES) between 9 DGAC, Richard D. Olson, M.D., M.P.H.; Activities; Notice of Meeting
a.m. and 4 p.m., Monday through
Office of Disease Prevention and Health Pursuant to section 10(a) of the
Friday.
Promotion, OASH/HHS; 1101 Wootton Federal Advisory Committee Act, as
Dated: April 2, 2015. Parkway, Suite LL100 Tower Building; amended (5 U.S.C. App.), notice is
Leslie Kux, Rockville, MD 20852: Telephone: (240) hereby given of the meeting of the
Associate Commissioner for Policy. 453–8280; Fax: (240) 453–8281; National Science Advisory Board for
[FR Doc. 2015–08017 Filed 4–7–15; 8:45 am] Alternate DFO, 2015 DGAC, Kellie Biosecurity (NSABB).
BILLING CODE 4164–01–P (O’Connell) Casavale, Ph.D., R.D.,
Name of Committee: National Science
Nutrition Advisor; Office of Disease Advisory Board for Biosecurity.
Prevention and Health Promotion, Date: May 5, 2015.
DEPARTMENT OF HEALTH AND OASH/HHS; 1101 Wootton Parkway, Time: 8:30 a.m.—3:30 p.m. Eastern.
HUMAN SERVICES Suite LL100 Tower Building; Rockville, Agenda: Presentations and discussions
MD 20852: Telephone: (240) 453–8280; regarding: (1) NSABB’s proposed framework
DEPARTMENT OF AGRICULTURE for guiding risk and benefit assessments of
Fax: (240) 453–8281; Lead USDA Co-
gain-of-function (GOF) studies involving
Solicitation of Written Comments on Executive Secretary, Colette I. Rihane, pathogens with pandemic potential; (2)
the Scientific Report of the 2015 M.S., R.D., Director, Office of Nutrition overview of conducting the risk and benefit
Dietary Guidelines Advisory Guidance and Analysis, Center for assessments; (3) planning for future NSABB
Committee; Extension of Comment Nutrition Policy and Promotion, USDA; deliberations on the GOF issue; and (4) other
Period 3101 Park Center Drive, Room 1034; business of the Board.
Place: National Institutes of Health, 9000
AGENCY: Office of the Assistant Alexandria, VA 22302; Telephone: (703)
Rockville Pike, Building 31, 6th Floor
Secretary for Health, Office of the 305–7600; Fax: (703) 305–3300; and/or Conference 10, Bethesda, Maryland 20892.
Secretary, Department of Health and USDA Co-Executive Secretary, Shanthy Contact Person: Carolyn Mosby, NSABB
Human Services; and Food, Nutrition A. Bowman, Ph.D., Nutritionist, Food Program Assistant, NIH Office of
Biotechnology Activities, 6705 Rockledge
asabaliauskas on DSK5VPTVN1PROD with NOTICES
and Consumer Services and Research, Surveys Research Group, Beltsville
Human Nutrition Research Center, Drive, Suite 750, Bethesda, Maryland 20892,
Education, and Economics. U.S.
(301) 435–5504, carolyn.mosby@nih.gov.
Department of Agriculture. Agricultural Research Service, USDA;
Under authority 42 U.S.C. 217a, Section
ACTION: Notice. 10300 Baltimore Avenue, BARC-West 222 of the Public Health Service Act, as
Bldg. 005, Room 125; Beltsville, MD amended, the Department of Health and
SUMMARY: A notice was published in the 20705–2350; Telephone: (301) 504– Human Services established the National
Federal Register on Monday, February 0619. Science Advisory Board for Biosecurity
23, 2015, Vol. 80, No. 35, pages 9465– (NSABB) to provide advice regarding federal
9466 to announce the availability of the oversight of dual use research, defined as
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Document Created: 2018-02-21 10:06:40
Document Modified: 2018-02-21 10:06:40
| 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 | |
| Action | Notice. | |
| Dates | Submit either an electronic or written request for participation in the ELP by May 8, 2015. The proposal should include a description of your facility relative to focus areas described in tables 1or 2). Please include the Area of Interest (see tables 1or 2) that the site visit will demonstrate to CDRH staff, a contact person, site visit location(s), length of site visit, proposed dates, and maximum number of CDRH staff that can be accommodated during a site visit. Proposals submitted without this minimum information will not be considered. In addition, please include an agenda outlining the proposed training for the site visit. A sample request and agenda are available on the ELP Web site at http://www.fda.gov/downloads/ScienceResearch/ ScienceCareerOpportunities/UCM392988.pdf and http://www.fda.gov/ scienceresearch/sciencecareeropportunities/ucm380676.htm. | |
| Contact | Latonya Powell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5232, Silver Spring, MD 20993-0002, 301-796-6965, FAX: 301-827-3079, [email protected] | |
| FR Citation | 80 FR 18850 |
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