80 FR 26059 - Withdrawal of Draft Guidance Documents Published Before December 31, 2013
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 87 (May 6, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 87 (May 6, 2015)
| Page Range | 26059-26061 | |
| FR Document | 2015-10477 |
[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)] [Notices] [Pages 26059-26061] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-10477] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-1419] Withdrawal of Draft Guidance Documents Published Before December 31, 2013 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the withdrawal of 47 draft guidance documents that published before December 31, 2013, and have never been finalized. FDA is taking this action to improve the efficiency and transparency of the guidance development process. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), if you wish to submit comments on a specific withdrawal action in this notice, submit either electronic or written comments by June 5, 2015. ADDRESSES: You may submit comments by any of the following methods: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Written Submissions Submit written submissions in the following ways: Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Docket No. FDA-2015-N-1419 for this action. All comments received may be posted without change to http://www.regulations.gov, including any personal information provided. Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number(s), found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Lisa M. Helmanis, Regulations Policy and Management Staff, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3326, Silver Spring, MD 20993-0002, 301-796-9135, email: Lisa.Helmanis.@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In September 2000, FDA codified its good guidance practices (GGPs). GGPs are FDA's policies and procedures for the development, issuance, and use of guidance documents. Level I guidance documents set forth initial interpretations of statutory or regulatory requirements, explain changes in interpretation of policies, or discuss complex scientific issues or highly controversial issues. The GGPs, generally, require that such guidances be issued in draft for public comment before they are finalized. FDA's guidance documents do not create [[Page 26060]] legally enforceable rights or responsibilities and do not legally bind the public or FDA. A key component of the GGPs is ensuring transparency during guidance development and issuance. In 2011, as part of the Agency's Transparency Initiative, FDA reviewed and set forth best practices for facilitating early stakeholder input, efficiency, and transparency in the Agency's processes, including GGPs. In recent years, FDA's guidance workload has increased due to requests from the public for guidance to clarify specific issues and statutorily mandated guidances. Many of these draft guidances were not finalized most often because of higher priorities and resource issues. However, over the years, because of new information, scientific developments, and emerging technologies, a number of draft guidances have become outdated and therefore, should be withdrawn. II. Withdrawal of Guidances FDA is withdrawing the following 47 guidance documents. ---------------------------------------------------------------------------------------------------------------- Draft guidance Docket No. Publication date ---------------------------------------------------------------------------------------------------------------- 1. Draft Guidance for Industry: Platelet FDA-1998-D-0680 5/20/1999 Testing and Evaluation of Platelet Substitute Products. 2. Draft Guidance for Industry: Precautionary FDA-1999-D-0045 2/11/2002 Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts. 3. Draft Guidance for Industry: Criteria for FDA-2004-D-0420 10/28/2004 Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes. 4. Draft Guidance for Industry: Validation of FDA-2008-D-0055 2/11/2008 Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products. 5. Draft Guidance for Industry: Use of FDA-2009-D-0137 3/26/2009 Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). 6. Accelerated Approval Products--Submission FDA-1999-D-0752 3/26/1999 of Promotional Materials. 7. Providing Regulatory Submissions in FDA-2001-D-0169 1/1/2001 Electronic Format--Prescription Drug Advertising and Promotional Labeling. 8. Comparability Protocols--Protein Drug FDA-2003-D-0355 9/5/2003 Products and Biological Products--Chemistry, Manufacturing, and Controls Information. 9. Providing Regulatory Submissions in FDA-2003-D-0429 10/1/2003 Electronic Format--General Considerations. 10. ``Help-Seeking'' and Other Disease FDA-2004-D-0500 1/26/2004 Awareness Communications by or on Behalf of Drug and Device Firms. 11. Notification to FDA of Issues that May FDA-2012-D-0140 2/21/2012 Result in a Prescription Drug or Biological Product Shortage. 12. Assessing the Safety and Effectiveness of FDA-1998-N-0050 10/5/1988 Home-Use In Vitro Diagnostic Devices: Draft Points to Consider Regarding Labeling and Premarket Submissions. 13. 510(k) Submission of Lymphocyte FDA-1998-N-0050 9/26/1991 Immunophenotyping IVDs Using Monoclonal FDA-2013-N-0046 Antibodies. 14. 510(k) Submission of Immunoglobulins A, G, FDA-1998-N-0050 9/1/1992 M, D, and E Immunoglobulin System In Vitro Devices. 15. Draft Guidance for Preparation of PMA FDA-1998-N-0050 3/16/1993 Applications for Testicular Prostheses. 16. Emergency Resuscitator Guidance........... FDA-1998-N-0050 4/14/1993 17. 510(k) Submission Requirements for Peak FDA-1998-N-0050 1/3/1994 Flow Meters. 18. Reviewer Guidance on Face Masks and Shield FDA-1998-N-0050 3/16/1994 for CPR. 19. Reviewer Guidance for Ventilators......... FDA-1998-N-0050 7/1/1995 20. Testing MR Interaction with Aneurysm Clips FDA-1998-N-0050 5/22/1996 21. A Primer on Medical Device Interactions FDA-1997-D-0423 2/7/1997 with Magnetic Resonance Imaging Systems. 22. Review Criteria Assessment of Portable FDA-2006-P-0022-0003 2/28/1997 Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology. 23. Distribution and Public Availability of FDA-1998-N-0050-0002 10/10/1997 Premarket Approval Application Summary of Safety and Effectiveness Data Packages (P97- 1). 24. Premarket Submissions and Labeling FDA-2003-D-0373 12/2/2003 Recommendations for Drugs of Abuse Screening Tests. 25. Class II Special Controls Guidance FDA-2005-D-0085 11/8/2005 Document: Tinnitus Masker Devices. 26. Class II Special Controls Guidance FDA-2006-D-0356 10/31/2006 Document: Absorbable Hemostatic Device. 27. Class II Special Controls Guidance FDA-2008-D-0603 12/22/2008 Document: Tissue Expander. 28. Heart Valves: Investigational Device FDA-2009-D-0559 1/20/2010 Exemption and Premarket Approval Applications. 29. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010 Document: Electroconductive Media. 30. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010 Document: Cutaneous Electrode. 31. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010 Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief. 32. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010 Document: Transcutaneous Electrical Nerve Stimulator with Limited Output for Pain Relief. 33. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010 Document: Transcutaneous Electrical Stimulator for Aesthetic Purposes. 34. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010 Document: Transcutaneous Electrical Stimulator with Limited Output for Aesthetic Purposes. 35. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010 Document: Powered Muscle Stimulator for Rehabilitation. 36. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010 Document: Powered Muscle Stimulator with Limited Output for Rehabilitation. 37. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010 Document: Powered Muscle Stimulator for Muscle Conditioning. 38. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010 Document: Powered Muscle Stimulator with Limited Output for Muscle Conditioning. 39. Class II Special Controls Guidance FDA-2009-D-0495 4/5/2010 Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use. [[Page 26061]] 40. Recommended Warning for Surgeon's Gloves FDA-2011-D-0030 2/7/2011 and Patient Examination Gloves. 41. Class II Special Controls Guidance FDA-2011-D-0102 5/18/2011 Document: In Vitro Diagnostic Devices for Bacillus spp. Detection. 42. Use of Antibiotic Resistance Marker Genes FDA-1998-N-0050 9/4/1998 in Transgenic Plants. 43. Drugs, Biologics, and Medical Devices FDA-2002-D-0135 9/11/2002 Derived from Bioengineered Plants for Use in Humans and Animals. 44. Preliminary Timetable for the Review of FDA-2009-D-0563 11/27/2009 Applications for Modified Risk Tobacco Products under the Federal Food, Drug, and Cosmetic Act. 45. Guidance for Industry: Regulatory FDA-1998-N-0050 11/5/2002 Procedures Manual--Chapter 9, Subchapter: Guidance Concerning Recommending Customs' Seizure and Destruction of Imported Human and Animal Food That has Not Been Reconditioned; Draft Guidance. 46. Submission of Laboratory Packages By FDA-2008-D-0510 1/2009 Accredited Laboratories. 47. Guidance for the Public and FDA Staff on FDA-2008-D-0417 8/1/2008 Convening Advisory Committee Meetings. ---------------------------------------------------------------------------------------------------------------- Dated: April 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-10477 Filed 5-5-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Notices 26059
Submit electronic comments on the requirements of the applicable statutes DATES: Although you can comment on
draft guidance to http:// and regulations. any guidance at any time (see 21 CFR
www.regulations.gov. Submit written 10.115(g)(5)), if you wish to submit
II. Comments
comments to the Division of Dockets comments on a specific withdrawal
Management (HFA–305), Food and Drug Interested persons may submit either action in this notice, submit either
Administration, 5630 Fishers Lane, Rm. electronic comments regarding this electronic or written comments by June
1061, Rockville, MD 20852. document to http://www.regulations.gov 5, 2015.
FOR FURTHER INFORMATION CONTACT: or written comments to the Division of ADDRESSES: You may submit comments
Mehul Mehta, Center for Drug Dockets Management (see ADDRESSES). It by any of the following methods:
Evaluation and Research, Food and is only necessary to send one set of
comments. Identify comments with the Electronic Submissions
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD docket number found in brackets in the Submit electronic comments in the
20993, 301–796–1573. heading of this document. Received following way:
SUPPLEMENTARY INFORMATION:
comments may be seen in the Division • Federal eRulemaking Portal: http://
of Dockets Management between 9 a.m. www.regulations.gov. Follow the
I. Background and 4 p.m., Monday through Friday, and instructions for submitting comments.
FDA is announcing the availability of will be posted to the docket at http://
www.regulations.gov. Written Submissions
a draft guidance for industry entitled
‘‘Waiver of In Vivo Bioavailability and III. Paperwork Reduction Act of 1995 Submit written submissions in the
Bioequivalence Studies for Immediate- following ways:
Release Solid Oral Dosage Forms Based This guidance refers to previously • Mail/Hand delivery/Courier (for
on a Biopharmaceutics Classification approved collections of information that paper submissions): Division of Dockets
System.’’ This guidance provides are subject to review by the Office of Management (HFA–305), Food and Drug
recommendations for sponsors and Management and Budget (OMB) under Administration, 5630 Fishers Lane, Rm.
applicants who wish to request a waiver the Paperwork Reduction Act of 1995 1061, Rockville, MD 20852.
of in vivo BA and/or BE studies for IR (44 U.S.C. 3501–3520). The collections Instructions: All submissions received
solid oral dosage forms. These waivers of information in 21 CFR part 314, must include the Docket No. FDA–
are intended to apply to: (1) Subsequent including §§ 314.50 and 314.94, have 2015–N–1419 for this action. All
in vivo BA or BE studies of formulations been approved under OMB control comments received may be posted
after the initial establishment of the in number 0910–0001. without change to http://
vivo BA of IR dosage forms during the IV. Electronic Access www.regulations.gov, including any
IND period and (2) in vivo BE studies personal information provided.
Persons with access to the Internet Docket: For access to the docket to
of IR dosage forms in ANDAs.
may obtain the document at either read background documents or
Regulations at 21 CFR part 320
http://www.fda.gov/Drugs/Guidance comments received, go to http://
address the requirements for BA and BE
ComplianceRegulatoryInformation/ www.regulations.gov and insert the
data for approval of drug applications
Guidances/default.htm or http:// docket number(s), found in brackets in
and supplemental applications.
www.regulations.gov. the heading of this document, into the
Provision for waivers of in vivo BA/BE
studies (biowaivers) under certain Dated: April 29, 2015. ‘‘Search’’ box and follow the prompts
conditions is provided at § 320.22. This Leslie Kux, and/or go to the Division of Dockets
guidance updates the guidance for Associate Commissioner for Policy. Management, 5630 Fishers Lane, Rm.
industry on ‘‘Waiver of In Vivo [FR Doc. 2015–10479 Filed 5–5–15; 8:45 am]
1061, Rockville, MD 20852.
Bioavailability and Bioequivalence BILLING CODE 4164–01–P FOR FURTHER INFORMATION CONTACT: Lisa
Studies for Immediate-Release Solid M. Helmanis, Regulations Policy and
Oral Dosage Forms Based on a Management Staff, Office of the
Biopharmaceutics Classification DEPARTMENT OF HEALTH AND Commissioner, Food and Drug
System,’’ published in August 2000, and HUMAN SERVICES Administration, 10903 New Hampshire
explains when biowaivers can be Ave., Bldg. 32, Rm. 3326, Silver Spring,
requested for IR solid oral dosage forms Food and Drug Administration MD 20993–0002, 301–796–9135, email:
based on an approach termed the Lisa.Helmanis.@fda.hhs.gov.
Biopharmaceutics Classification System [Docket No. FDA–2015–N–1419]
SUPPLEMENTARY INFORMATION:
(BCS). This guidance includes
Withdrawal of Draft Guidance I. Background
biowaiver extension to BCS class 3 drug
Documents Published Before
products and additional modifications, In September 2000, FDA codified its
December 31, 2013
such as criteria for high permeability good guidance practices (GGPs). GGPs
and high solubility. AGENCY: Food and Drug Administration, are FDA’s policies and procedures for
This draft guidance is being issued HHS. the development, issuance, and use of
consistent with FDA’s good guidance ACTION: Notice. guidance documents. Level I guidance
practices regulation (21 CFR 10.115). documents set forth initial
The draft guidance, when finalized, will SUMMARY: The Food and Drug interpretations of statutory or regulatory
represent FDA’s current thinking on Administration (FDA) is announcing the requirements, explain changes in
tkelley on DSK3SPTVN1PROD with NOTICES
waiver of in vivo bioavailability and withdrawal of 47 draft guidance interpretation of policies, or discuss
bioequivalence studies for immediate- documents that published before complex scientific issues or highly
release solid oral dosage forms based on December 31, 2013, and have never controversial issues. The GGPs,
a BCS. It does not establish any rights been finalized. FDA is taking this action generally, require that such guidances
for any person and is not binding on to improve the efficiency and be issued in draft for public comment
FDA or the public. You can use an transparency of the guidance before they are finalized. FDA’s
alternative approach if it satisfies the development process. guidance documents do not create
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![Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Notices 26061
Draft guidance Docket No. Publication date
40. Recommended Warning for Surgeon’s Gloves and Patient Examination Gloves ........................ FDA–2011–D–0030 2/7/2011
41. Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. FDA–2011–D–0102 5/18/2011
Detection.
42. Use of Antibiotic Resistance Marker Genes in Transgenic Plants ............................................... FDA–1998–N–0050 9/4/1998
43. Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans FDA–2002–D–0135 9/11/2002
and Animals.
44. Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products FDA–2009–D–0563 11/27/2009
under the Federal Food, Drug, and Cosmetic Act.
45. Guidance for Industry: Regulatory Procedures Manual—Chapter 9, Subchapter: Guidance FDA–1998–N–0050 11/5/2002
Concerning Recommending Customs’ Seizure and Destruction of Imported Human and Animal
Food That has Not Been Reconditioned; Draft Guidance.
46. Submission of Laboratory Packages By Accredited Laboratories ................................................ FDA–2008–D–0510 1/2009
47. Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings ................ FDA–2008–D–0417 8/1/2008
Dated: April 30, 2015. guidance before it begins work on the treatment (i.e., from birth through the
Leslie Kux, final version of the guidance, submit 21st year of life, up to but not including
Associate Commissioner for Policy. either electronic or written comments the 22d birthday). Pediatric
[FR Doc. 2015–10477 Filed 5–5–15; 8:45 am] on the draft guidance by August 4, 2015. subpopulations are defined in section
BILLING CODE 4164–01–P ADDRESSES: An electronic copy of the 520(m)(6)(E)(ii) (and adopted by
guidance document is available for reference in section 515A(c) of the
download from the Internet. See the FD&C Act (21 U.S.C. 360e)) to be
DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION section for neonates, infants, children, and
HUMAN SERVICES information on electronic access to the adolescents.
guidance. Submit written requests for a In an attempt to promote pediatric
Food and Drug Administration single hard copy of the draft guidance medical device development, CDRH
[Docket No. FDA–2015–D–1376] document entitled ‘‘Leveraging Existing published a final guidance document in
Clinical Data for Extrapolation to 2004 entitled ‘‘Premarket Assessment of
Leveraging Existing Clinical Data for Pediatric Uses of Medical Devices’’ to Pediatric Medical Devices’’ (Ref. 1). This
Extrapolation to Pediatric Uses of the Office of the Center Director, 2004 document indicates that data can
Medical Devices; Draft Guidance for Guidance and Policy Development, be extrapolated to support effectiveness
Industry and Food and Drug Center for Devices and Radiological and, on a limited basis, safety for
Administration Staff; Availability Health (CDRH), Food and Drug premarket approval applications (PMAs)
AGENCY: Food and Drug Administration, Administration, 10903 New Hampshire when consistent with scientific
HHS. Ave., Bldg. 66, Rm. 5431, Silver Spring, principles. Congress was aware of this
MD 20993–0002. Send one self- 2004 document when it passed the Food
ACTION: Notice.
addressed adhesive label to assist that and Drug Administration Amendments
SUMMARY: The Food and Drug office in processing your request. Act of 2007 (FDAAA). Title III of
Administration (FDA) is announcing the Submit electronic comments on the FDAAA is the Pediatric Medical Device
availability of the draft guidance draft guidance to http:// Safety and Improvement Act (PMDSIA).
entitled ‘‘Leveraging Existing Clinical www.regulations.gov. Submit written The FDAAA specifically authorized the
Data for Extrapolation to Pediatric Uses comments to the Division of Dockets use of adult data to demonstrate
of Medical Devices.’’ This draft Management (HFA–305), Food and Drug pediatric effectiveness. While safety
guidance is being issued to explain the Administration, 5630 Fishers Lane, Rm. exploration is not discussed in PMDSIA,
circumstances in which it may be 1061, Rockville, MD 20852. Identify FDA believes that there are specific
appropriate to leverage existing clinical comments with the docket number cases where it will be appropriate to
data to support pediatric device found in brackets in the heading of this consider extrapolation of existing
indications in premarket approval document. clinical safety data to support or
applications (PMAs) and humanitarian FOR FURTHER INFORMATION CONTACT: enhance evidence for pediatric
device exemptions (HDEs). The draft Jacqueline Francis, Center for Devices indications. FDA seeks comment on the
guidance also describes the approach and Radiological Health, Food and Drug appropriateness of extrapolating from
that FDA would use to determine Administration, 10903 New Hampshire adult clinical data to support medical
whether extrapolation is appropriate in Ave., Bldg. 66, Silver Spring, MD device safety in pediatric patients.
medical devices, and the factors that 20993–0002, 301–796–6405; or Stephen FDA aims to increase the availability
would be considered within a statistical Ripley, Center for Biologics Evaluation of safe and effective pediatric devices
model for extrapolation. Extrapolation and Research (CBER), Food and Drug while ensuring that the approval of
may be appropriate when the course of Administration, 10903 New Hampshire these devices is based on valid scientific
the disease or condition and the effects Ave., Bldg. 71, Rm. 7301, Silver Spring, evidence. Extrapolation of adult data for
of the device are sufficiently similar in MD 20993–0002, 240–402–7911. pediatric use may benefit pediatric
adults and pediatric patients and the SUPPLEMENTARY INFORMATION: patients by making it possible for
tkelley on DSK3SPTVN1PROD with NOTICES
adult data are of high quality for devices to be approved for pediatric-
borrowing. This draft guidance is not I. Background specific indications and labeling, even
final nor is it in effect at this time. Section 520(m)(6)(E)(i) of the Federal when there is little or no existing
DATES: Although you can comment on Food, Drug, and Cosmetic Act (FD&C pediatric data. Extrapolation facilitates
any guidance at any time (see 21 CFR Act) (21 U.S.C. 360j) defines pediatric the use of available relevant data by
10.115(g)(5)), to ensure that the Agency device patients as persons aged 21 or making optimal use of what is already
considers your comment of this draft younger at the time of their diagnosis or known about device effects in other
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Document Created: 2015-12-16 07:40:46
Document Modified: 2015-12-16 07:40:46
| 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 | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), if you wish to submit comments on a specific withdrawal action in this notice, submit either electronic or written comments by June 5, 2015. | |
| Contact | Lisa M. Helmanis, Regulations Policy and Management Staff, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3326, Silver Spring, MD 20993-0002, 301-796-9135, email: [email protected] | |
| FR Citation | 80 FR 26059 |
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