80 FR 66907 - Investigational New Drug Applications-Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards; Partial Stay and Republication of Guidance
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 210 (October 30, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 210 (October 30, 2015)
| Page Range | 66907-66909 | |
| FR Document | 2015-27729 |
[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)] [Notices] [Pages 66907-66909] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27729] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0503] Investigational New Drug Applications--Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards; Partial Stay and Republication of Guidance AGENCY: Food and Drug Administration, HHS. ACTION: Notice of administrative stay of action. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing a stay of portions of the final guidance for clinical investigators, sponsors, and institutional review boards (IRBs) entitled ``Investigational New Drug Applications--Determining Whether Human Research Studies Can Be Conducted Without an IND.'' We are republishing the guidance with the portions that are being stayed clearly identified so readers can distinguish parts of the guidance that remain in effect from parts that are subject to this stay. DATES: This stay is effective October 30, 2015 Submit either electronic or written comments on FDA guidances at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2010-D-0503 for ``Investigational New Drug Applications-- Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards; Partial Stay and Republication of Guidance.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential [[Page 66908]] information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, 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: Philip L. Chao, Center for Food Safety and Applied Nutrition (HFS-024), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2112, email: [email protected]; or Ebla Ali-Ibrahim, Center for Drug Evaluation and Research (HFD-160), Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3691; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of October 14, 2010 (75 FR 63189), we announced the availability of a draft guidance entitled ``Guidance for Industry: Investigational New Drug Applications (INDs)--Determining Whether Human Research Studies can be Conducted without an IND'' (``the draft guidance''). In the Federal Register of September 10, 2013 (78 FR 55262), we published a document announcing the availability of the final version of the guidance, now entitled ``Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards (IRBs) on Investigational New Drug Applications--Determining Whether Human Research Studies Can Be Conducted Without an IND'' (``the final guidance''). We received multiple comments asking for a further opportunity to comment on subsections VI.C and VI.D of the final guidance, which discuss when an IND is needed for studies involving products marketed as cosmetics or foods, respectively. Accordingly, on February 6, 2014, we issued a document reopening the comment period on only those subsections of the final guidance that address the applicability of the IND regulations to clinical research studies involving products marketed as cosmetics or foods (including dietary supplements) (79 FR 7204) (``notice to reopen''). The comment period closed on April 7, 2014. We received comments from trade organizations, individual companies, scientific associations, public interest organizations, and individuals in response to our notice to reopen. These comments raised questions about application of the IND requirement to certain clinical studies of conventional foods, dietary supplements, and cosmetics being investigated for uses covered by the drug definition in section 201(g)(1)(B) or (C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(g)(1)(B) or (C)). II. The Stay FDA is staying part of the final guidance to allow for further consideration of issues raised by the comments submitted in response to the notice to reopen. Specifically, we are staying portions of subsection VI.D.2, ``Conventional Food,'' and all of subsection VI.D.3, ``Studies Intended to Support a Health Claim,'' except as to studies intended to evaluate whether a food substance reduces the risk of a disease in individuals less than 12 months old, those with altered immune systems, and those with serious or life-threatening medical conditions. Subsections VI.D.2 and VI.D.3 discuss, respectively, conventional food studies generally and studies intended to support a health claim for a conventional food or dietary supplement. The portions of subsection VI.D.2 that are being stayed are the third paragraph (which pertains to clinical studies intended to evaluate a food's effect on the structure or function of the body) and a sentence in the fourth paragraph concerning clinical studies intended to evaluate a non-nutritional effect on the structure or function of the body. In subsection VI.D.3, a text box inserted below the subsection heading explains that clinical investigations intended to evaluate whether a food substance may reduce the risk of a disease in three categories of medically vulnerable subjects (individuals less than 12 months old, those with altered immune systems, and those with serious or life-threatening medical conditions) are excluded from the stay, and that subsection VI.D.3 is in effect for such investigations. The stay of portions of subsection VI.D.2 and all of subsection VI.D.3 (subject to the exclusion for studies in the medically vulnerable populations described in this document) of the final guidance is effective immediately. All other parts of the final guidance remain in effect. We are republishing the guidance with the stayed material clearly identified so readers can distinguish parts of the guidance that remain in effect from parts that are subject to the stay. FDA generally does not intend to seek INDs for studies in the stayed categories while the stay is in effect. This stay does not, however, preclude enforcement of any provision of the FD&C Act or other relevant Federal statutes or regulations other than IND requirements (e.g., human subject protection laws and regulations). This stay does not affect investigations of conventional foods or dietary supplements studied for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Products intended for such uses meet the definition of a ``drug'' at section 201(g)(1)(B) of the FD&C Act; such investigations will continue to be subject to IND requirements. For example, dietary supplements containing bacteria have been given to infants born prematurely for prevention of necrotizing enterocolitis. The investigation of such use, and similar uses of conventional foods or dietary supplements to diagnose, cure, mitigate, treat, or prevent a disease, continues to require an IND. In summary, while the partial stay of the final guidance is in effect, FDA does not consider clinical investigators or study sponsors to be under any [[Page 66909]] obligation to obtain an IND for the following types of studies evaluating the effects of a product marketed as a conventional food or dietary supplement: For conventional foods: Clinical studies designed to evaluate whether a conventional food may reduce the risk of a disease, intended to support a new or expanded health claim, and conducted in a population that does not include individuals less than 12 months old, those with altered immune systems, or those with serious or life-threatening medical conditions; Clinical studies designed to evaluate a non-nutritional effect of a conventional food on the structure or function of the body. For dietary supplements: Clinical studies designed to evaluate whether a dietary supplement may reduce the risk of a disease, intended to support a new or expanded health claim, and conducted in a population that does not include individuals less than 12 months old, those with altered immune systems, or those with serious or life-threatening medical conditions. Further, as noted in the final guidance itself, no IND is required for clinical studies designed to evaluate the nutritional effects of a conventional food, clinical studies designed to evaluate a dietary supplement's effects on the structure or function of the body, or clinical studies designed to evaluate the relationship between a conventional food or dietary supplement and reduced risk of a disease, if there is already an authorized health claim for the substance- disease relationship. The following types of studies do continue to require an IND for the reasons explained in the final guidance: For conventional foods: Clinical studies designed to evaluate a conventional food's ability to diagnose, cure, mitigate, treat, or prevent a disease, except for studies designed to evaluate whether a conventional food reduces the risk of a disease, intended to support a health claim, and conducted in a population that does not include individuals less than 12 months old, those with altered immune systems, or those with serious or life-threatening medical conditions; Clinical studies designed to evaluate whether a food substance reduces the risk of a disease, intended to support a new or expanded health claim, and conducted in a population that includes individuals less than 12 months old, those with altered immune systems, or those with serious or life-threatening medical conditions. For dietary supplements: Clinical studies designed to evaluate a dietary supplement's ability to diagnose, cure, mitigate, treat, or prevent a disease, except for studies designed to evaluate whether a dietary supplement reduces the risk of a disease, intended to support a health claim, and conducted in a population that does not include individuals less than 12 months old, those with altered immune systems, or those with serious or life-threatening medical conditions; Clinical studies designed to evaluate whether a dietary supplement reduces the risk of a disease, intended to support a new or expanded health claim, and conducted in a population that includes individuals less than 12 months old, those with altered immune systems, or those with serious or life-threatening medical conditions. For cosmetics: Clinical studies designed to evaluate a cosmetic's effect on the structure or function of the body or its ability to diagnose, cure, mitigate, treat, or prevent a disease. Dated: October 26, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-27729 Filed 10-29-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Notices 66907
label to assist that office in processing II. The Paperwork Reduction Act of Electronic Submissions
your requests. See the SUPPLEMENTARY 1995 Submit electronic comments in the
INFORMATION section for electronic
This revised draft guidance refers to following way:
access to the draft guidance document. previously approved collections of • Federal eRulemaking Portal: http://
FOR FURTHER INFORMATION CONTACT: information that are subject to review by www.regulations.gov. Follow the
Richard T. Lostritto, Center for Drug the Office of Management and Budget instructions for submitting comments.
Evaluation and Research, Food and (OMB) under the Paperwork Reduction Comments submitted electronically,
Drug Administration, 10903 New Act of 1995 (44 U.S.C. 3501–3520). The including attachments, to http://
Hampshire Ave., Bldg. 51, Rm. 4148, collections of information in 21 CFR www.regulations.gov will be posted to
Silver Spring, MD 20993–0002, 301– part 314 have been approved under the docket unchanged. Because your
796–1697. OMB control number 0910–0001. comment will be made public, you are
SUPPLEMENTARY INFORMATION: solely responsible for ensuring that your
III. Electronic Access
comment does not include any
I. Background Persons with access to the Internet confidential information that you or a
may obtain the revised draft guidance at third party may not wish to be posted,
The FDA is announcing the
either http://www.fda.gov/Drugs/ such as medical information, your or
availability of a revised draft guidance
GuidanceComplianceRegulatory anyone else’s Social Security number, or
for industry entitled ‘‘Liposome Drug
Information/Guidances/default.htm or confidential business information, such
Products: Chemistry, Manufacturing,
http://www.regulations.gov. as a manufacturing process. Please note
and Controls; Human Pharmacokinetics
and Bioavailability; and Labeling Dated: October 26, 2015. that if you include your name, contact
Documentation.’’ This revised draft Leslie Kux, information, or other information that
guidance provides recommendations to Associate Commissioner for Policy.
identifies you in the body of your
applicants on the CMC, human comments, that information will be
[FR Doc. 2015–27744 Filed 10–29–15; 8:45 am]
pharmacokinetics and bioavailability, posted on http://www.regulations.gov.
and labeling documentation for
BILLING CODE 4164–01–P
• If you want to submit a comment
liposome drug products submitted in with confidential information that you
NDAs, ANDAs, and BLAs reviewed by do not wish to be made available to the
DEPARTMENT OF HEALTH AND
CDER. This revision adds BLAs and public, submit the comment as a
HUMAN SERVICES
ANDAs. It also updates the discussions written/paper submission and in the
on liposome technology. Food and Drug Administration manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
In the Federal Register of August 21, [Docket No. FDA–2010–D–0503]
2002 (67 FR 54220), FDA announced the Written/Paper Submissions
availability of a draft version of this Investigational New Drug Submit written/paper submissions as
guidance. FDA received comments in Applications—Determining Whether follows:
response to the draft guidance, and this Human Research Studies Can Be • Mail/Hand delivery/Courier (for
revised guidance reflects FDA’s careful Conducted Without an Investigational written/paper submissions): Division of
consideration of these comments. Most New Drug Application; Guidance for Dockets Management (HFA–305), Food
of the changes to the revised draft Clinical Investigators, Sponsors, and and Drug Administration, 5630 Fishers
guidance were made to clarify Institutional Review Boards; Partial Lane, Rm. 1061, Rockville, MD 20852.
statements in the 2002 draft guidance. Stay and Republication of Guidance • For written/paper comments
In addition, FDA decided to publish a submitted to the Division of Dockets
revised draft guidance because of AGENCY: Food and Drug Administration,
Management, FDA will post your
changes in technology since the draft HHS.
comment, as well as any attachments,
was first published in 2002, the addition ACTION: Notice of administrative stay of except for information submitted,
of BLAs reviewed by CDER as a result action. marked and identified, as confidential,
of a CDER and Center for Biologics if submitted as detailed in
Evaluation and Research reorganization SUMMARY: The Food and Drug
Administration (FDA or we) is ‘‘Instructions.’’
in 2003, and the addition of ANDAs. Instructions: All submissions received
The revised draft guidance does not announcing a stay of portions of the
final guidance for clinical investigators, must include the Docket No. FDA–
provide recommendations on clinical 2010–D–0503 for ‘‘Investigational New
efficacy and safety studies, nonclinical sponsors, and institutional review
boards (IRBs) entitled ‘‘Investigational Drug Applications—Determining
pharmacology and/or toxicology Whether Human Research Studies Can
studies, liposome formulations of New Drug Applications—Determining
Whether Human Research Studies Can Be Conducted Without an
vaccine adjuvants or biologics, or drug- Investigational New Drug Application;
lipid complexes. Be Conducted Without an IND.’’ We are
republishing the guidance with the Guidance for Clinical Investigators,
This revised draft guidance is being portions that are being stayed clearly Sponsors, and Institutional Review
issued consistent with FDA’s good identified so readers can distinguish Boards; Partial Stay and Republication
guidance practices regulation (21 CFR parts of the guidance that remain in of Guidance.’’ Received comments will
10.115). This revised draft guidance, effect from parts that are subject to this be placed in the docket and, except for
when finalized, will represent the stay. those submitted as ‘‘Confidential
tkelley on DSK3SPTVN1PROD with NOTICES
Agency’s current thinking on liposome Submissions,’’ publicly viewable at
DATES: This stay is effective October 30,
drug products. It does not establish any http://www.regulations.gov or at the
rights for any person and is not binding 2015 Submit either electronic or written Division of Dockets Management
on FDA or the public. You can use an comments on FDA guidances at any between 9 a.m. and 4 p.m., Monday
alternative approach if it satisfies the time. through Friday.
requirements of the applicable statutes ADDRESSES: You may submit comments • Confidential Submissions—To
and regulations. as follows: submit a comment with confidential
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![Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Notices 66909
obligation to obtain an IND for the For dietary supplements: Conference Center, the Great Room (Rm.
following types of studies evaluating the • Clinical studies designed to 1503), Silver Spring, MD 20993–0002.
effects of a product marketed as a evaluate a dietary supplement’s ability Entrance for the public meeting
conventional food or dietary to diagnose, cure, mitigate, treat, or participants (non-FDA employees) is
supplement: prevent a disease, except for studies through Building 1 where routine
For conventional foods: designed to evaluate whether a dietary security check procedures will be
• Clinical studies designed to supplement reduces the risk of a performed. For parking and security
evaluate whether a conventional food disease, intended to support a health information, please refer to http://
may reduce the risk of a disease, claim, and conducted in a population www.fda.gov/AboutFDA/
intended to support a new or expanded that does not include individuals less WorkingatFDA/BuildingsandFacilities/
health claim, and conducted in a than 12 months old, those with altered WhiteOakCampusInformation/
population that does not include immune systems, or those with serious ucm241740.htm.
individuals less than 12 months old, or life-threatening medical conditions; You may submit comments as
those with altered immune systems, or • Clinical studies designed to follows:
those with serious or life-threatening evaluate whether a dietary supplement
medical conditions; Electronic Submissions
reduces the risk of a disease, intended
• Clinical studies designed to to support a new or expanded health Submit electronic comments in the
evaluate a non-nutritional effect of a claim, and conducted in a population following way:
conventional food on the structure or that includes individuals less than 12 • Federal eRulemaking Portal: http://
function of the body. months old, those with altered immune www.regulations.gov. Follow the
For dietary supplements: systems, or those with serious or life- instructions for submitting comments.
• Clinical studies designed to threatening medical conditions. Comments submitted electronically,
evaluate whether a dietary supplement For cosmetics: including attachments, to http://
may reduce the risk of a disease, • Clinical studies designed to www.regulations.gov will be posted to
intended to support a new or expanded evaluate a cosmetic’s effect on the the docket unchanged. Because your
health claim, and conducted in a structure or function of the body or its comment will be made public, you are
population that does not include ability to diagnose, cure, mitigate, treat, solely responsible for ensuring that your
individuals less than 12 months old, or prevent a disease. comment does not include any
those with altered immune systems, or confidential information that you or a
Dated: October 26, 2015.
those with serious or life-threatening third party may not wish to be posted,
Leslie Kux,
medical conditions. such as medical information, your or
Further, as noted in the final guidance Associate Commissioner for Policy. anyone else’s Social Security number, or
itself, no IND is required for clinical [FR Doc. 2015–27729 Filed 10–29–15; 8:45 am] confidential business information, such
studies designed to evaluate the BILLING CODE 4164–01–P as a manufacturing process. Please note
nutritional effects of a conventional that if you include your name, contact
food, clinical studies designed to information, or other information that
evaluate a dietary supplement’s effects DEPARTMENT OF HEALTH AND identifies you in the body of your
on the structure or function of the body, HUMAN SERVICES comments, that information will be
or clinical studies designed to evaluate posted on http://www.regulations.gov.
Food and Drug Administration
the relationship between a conventional • If you want to submit a comment
food or dietary supplement and reduced [Docket No. FDA–2015–N–3805] with confidential information that you
risk of a disease, if there is already an do not wish to be made available to the
authorized health claim for the Clinical Trials—Assessing Safety and public, submit the comment as a
substance-disease relationship. Efficacy for Diverse Populations; written/paper submission and in the
The following types of studies do Public Meeting; Request for Comments manner detailed (see ‘‘Written/Paper
continue to require an IND for the AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’).
reasons explained in the final guidance: HHS.
For conventional foods: Written/Paper Submissions
• Clinical studies designed to Notice of meeting; request for
ACTION:
Submit written/paper submissions as
evaluate a conventional food’s ability to comments. follows:
diagnose, cure, mitigate, treat, or SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for
prevent a disease, except for studies Administration (FDA), in collaboration written/paper submissions): Division of
designed to evaluate whether a with the Johns Hopkins Center of Dockets Management (HFA–305), Food
conventional food reduces the risk of a Excellence in Regulatory Science and and Drug Administration, 5630 Fishers
disease, intended to support a health Innovation, is announcing a public Lane, Rm. 1061, Rockville, MD 20852.
claim, and conducted in a population workshop entitled ‘‘Clinical Trials— • For written/paper comments
that does not include individuals less Assessing Safety and Efficacy in Diverse submitted to the Division of Dockets
than 12 months old, those with altered Populations.’’ The purpose of the Management, FDA will post your
immune systems, or those with serious meeting is to discuss approaches in comment, as well as any attachments,
or life-threatening medical conditions; clinical trial design and subgroup except for information submitted,
• Clinical studies designed to marked and identified, as confidential,
analyses for therapeutic product
evaluate whether a food substance if submitted as detailed in
development and life-cycle
tkelley on DSK3SPTVN1PROD with NOTICES
reduces the risk of a disease, intended ‘‘Instructions.’’
management.
to support a new or expanded health Instructions: All submissions received
claim, and conducted in a population DATES:The meeting will be held on must include the Docket No. FDA–
that includes individuals less than 12 December 2, 2015, from 9 a.m. to 5 p.m. 2015–N–3805 for Clinical Trials—
months old, those with altered immune ADDRESSES: The meeting will be held at Assessing Safety and Efficacy for
systems, or those with serious or life- the FDA White Oak Campus, 10903 Diverse Populations; Public Meeting;
threatening medical conditions. New Hampshire Ave., Bldg. 31 Request for Comments. Received
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Document Created: 2015-12-14 15:29:16
Document Modified: 2015-12-14 15:29:16
| 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 of administrative stay of action. | |
| Dates | This stay is effective October 30, 2015 Submit either electronic or written comments on FDA guidances at any time. | |
| Contact | Philip L. Chao, Center for Food Safety and Applied Nutrition (HFS-024), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2112, email: [email protected]; or Ebla Ali-Ibrahim, Center for Drug Evaluation and Research (HFD-160), Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3691; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911. | |
| FR Citation | 80 FR 66907 |
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