80 FR 17050 - Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 61 (March 31, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 61 (March 31, 2015)
| Page Range | 17050-17051 | |
| FR Document | 2015-07273 |
[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)] [Notices] [Pages 17050-17051] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-07273] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0500] Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; requests for comments. ----------------------------------------------------------------------- [[Page 17051]] SUMMARY: The Food and Drug Administration (FDA) is announcing a request for additional comments on the chemistry, manufacturing, and control (CMC) information that a sponsor of an investigational new drug application (IND) should provide in its IND in order to meet regulatory requirements when commercially available foods or dietary supplements containing live biotherapeutic products (LBPs) are used as investigational new drugs in early phase clinical trials. The request for additional comments on the CMC information is related to the guidance entitled, ``Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry,'' dated February 2012 (February 2012 guidance). DATES: Submit either electronic or written comments on the requested CMC information by May 29, 2015. ADDRESSES: Submit written requests for single copies of the February 2012 guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-7800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the requested CMC information to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Jessica T. Walker, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing a request for additional comments on the CMC information that a sponsor of an IND should provide in its IND in order to meet the requirements under Sec. 312.23 (21 CFR 312.23), when commercially available foods or dietary supplements containing LBPs are subject to study as investigational new drugs in early phase clinical trials. In the Federal Register of February 21, 2012 (77 FR 9947), FDA announced the publication of a final guidance entitled ``Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry,'' dated February 2012. The guidance provides IND sponsors with recommendations regarding CMC information that should be included in IND submissions for early clinical trials with LBPs, including LBPs lawfully marketed as foods or dietary supplements in the United States and proposed for clinical uses regulated under section 351 of the Public Health Service Act (42 U.S.C. 262). The guidance also outlines the Drug Substance and Drug Product information that should be provided in the CMC section of an IND to meet the requirements under Sec. 312.23 and to support proceeding to clinical evaluation of an LBP in human subjects. II. CMC Information FDA is considering modifying the February 2012 guidance to address the CMC information that should be provided in an IND, under certain conditions. Specifically, FDA is considering whether to revise the guidance to address when the label on the commercially available product(s) would be considered adequate to satisfy the requirement for CMC information under Sec. 312.23. For example, we are considering whether the label would be adequate to satisfy the CMC information when the following conditions are met: (1) The LBP product that is proposed for investigational use is a commercially available food or dietary supplement; (2) the investigation does not involve a route of administration, dose, patient population, or other factor that significantly increases the risk (or decreases the acceptability of risk) associated with the use of the food or dietary supplement; (3) the investigation is not intended to support a marketing application for a drug claim for the food or dietary supplement; and (4) the investigation is conducted in compliance with the requirements for INDs (part 312), the requirements for review by an institutional review board (21 CFR part 56), and with the requirements for informed consent (21 CFR part 50). FDA is seeking public comment on this issue. III. Comments Interested persons may submit either electronic comments regarding the requested CMC information to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the February 2012 guidance at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: March 25, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-07273 Filed 3-30-15; 8:45 am] BILLING CODE 4164-01-P
![17050 Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices
registered nurse in the home health considered the conduct that forms the capacity to a person with an approved
field, it was Ms. Fernandez’s duty to basis of her conviction and the fact that or pending drug product application
provide skilled nursing services to this conduct occurred in the course of under sections 505, 512, or 802 of the
patients and maintain proper her profession and showed a disregard FD&C Act (21 U.S.C. 355, 360b, or 382),
documentation of all treatments for the obligations of her profession and or under section 351 of the Public
provided to patients. the law, FDA found that Ms. Fernandez Health Service Act (42 U.S.C. 262),
From on or about August 17, 2007, has demonstrated a pattern of conduct effective (see DATES)(see sections
through on or about March 19, 2009, sufficient to find that there is reason to 201(dd), 306(c)(1)(B), and
Ms. Fernandez conspired with others to believe that, if she were to provide 306(c)(2)(A)(ii) of the FD&C Act, (21
defraud Medicare. services to a person that has an U.S.C. 321(dd), 335a(c)(1)(B), and
Ms. Fernandez and her coconspirators approved or pending drug application, 335a(c)(2)(A)(ii)). Any person with an
submitted, and caused the submission she may violate requirements under the approved or pending drug product
of, false and fraudulent claims to FD&C Act relating to drug products. The application who knowingly employs or
Medicare, and concealed the submission proposal offered Ms. Fernandez an retains as a consultant or contractor, or
of these false and fraudulent claims. opportunity to request a hearing, otherwise uses the services of Ms.
Ms. Fernandez and her coconspirators providing her with 30 days from the Fernandez in any capacity during her
falsified and caused Medicare date of receipt of the letter in which to debarment, will be subject to civil
beneficiaries to falsify weekly visit/time file the request, and advised her that money penalties (section 307(a)(6) of the
record sheets, and falsified skilled failure to request a hearing constituted FD&C Act (21 U.S.C. 335b(a)(6))). If Ms.
nursing progress notes representing that a waiver of the opportunity for a hearing Fernandez provides services in any
she had administered insulin injections and of any contentions concerning this capacity to a person with an approved
and provided other medical services to action. The proposal was received on or pending drug product application
Medicare beneficiaries. She caused Ideal September 12, 2014. Ms. Fernandez during her period of debarment she will
to submit false and fraudulent claims to failed to respond within the timeframe be subject to civil money penalties
Medicare for home health benefits by prescribed by regulation and has, (section 307(a)(7) of the FD&C Act). In
falsely representing that she had therefore, waived her opportunity for a addition, FDA will not accept or review
provided these health services. As a hearing and has waived any contentions any abbreviated new drug applications
result of these fraudulent claims, she concerning her debarment (21 CFR part submitted by or with the assistance of
caused Medicare to make payments to 12). Odalys Fernandez during her period of
Ideal of approximately $82,040. Ms.
II. Findings and Order debarment (section 306(c)(1)(A) of the
Fernandez engaged in this criminal
FD&C Act).
conduct repeatedly over a period of Therefore, the Director, Office of
Any application by Ms. Fernandez for
approximately 19 months. Enforcement and Import Operations,
As a result of her convictions, on termination of debarment under section
Office of Regulatory Affairs, under
September 8, 2014, FDA sent Ms. 306(d)(4) of the FD&C Act should be
section 306(b)(2)(B)(ii)(I) of the FD&C
Fernandez a notice by certified mail identified with Docket No. FDA–2014–
Act, under authority delegated to the
proposing to debar her for 6 years from N–0563 and sent to the Division of
Director (Staff Manual Guide 1410.35),
providing services in any capacity to a Dockets Management (see ADDRESSES).
finds that Odalys Fernandez has been
person that has an approved or pending convicted of five counts of a felony and All such submissions are to be filed in
drug product application. The proposal one count of conspiracy to commit a four copies. The public availability of
was based on the finding, under section felony under Federal law for conduct information in these submissions is
306(b)(2)(B)(ii)(I) of the FD&C Act, that involving health care fraud and, on the governed by 21 CFR 10.20.
Ms. Fernandez was convicted of felonies basis of the conviction and other Publicly available submissions may
under Federal law for conduct involving information, finds that Ms. Fernandez be seen in the Division of Dockets
health care fraud and conspiracy to has demonstrated a pattern of conduct Management between 9 a.m. and 4 p.m.,
commit health care fraud, and the sufficient to find that there is reason to Monday through Friday.
Agency found, on the basis of the believe she may violate requirements Dated: March 24, 2015.
conviction and other information, that under the FD&C Act relating to drug Leslie Kux,
Ms. Fernandez had demonstrated a products. Associate Commissioner for Policy.
pattern of conduct sufficient to find that Based on the factors under section [FR Doc. 2015–07267 Filed 3–30–15; 8:45 am]
there is reason to believe she may 306(c)(2)(A)(iii) of the FD&C Act, FDA BILLING CODE 4164–01–P
violate requirements under the FD&C finds that each offense be accorded a
Act relating to drug products. This debarment period of 3 years. In the case
conclusion was based on the fact that of a person debarred for multiple DEPARTMENT OF HEALTH AND
Ms. Fernandez had legal and offenses, FDA shall determine whether HUMAN SERVICES
professional obligations to ensure that the periods of debarment shall run
she submitted accurate medical claims concurrently or consecutively (section Food and Drug Administration
for services she provided. Instead, Ms. 306(c)(2)(A)). FDA has concluded that
Fernandez submitted, and caused the the 3-year periods of debarment for the [Docket No. FDA–2010–D–0500]
submission of, false weekly visit/time five counts of health care fraud shall run
records and false daily blood sugar/ concurrently. The 3-year period of Early Clinical Trials With Live
asabaliauskas on DSK5VPTVN1PROD with NOTICES
insulin log sheets. She engaged in this debarment for the conspiracy conviction Biotherapeutic Products: Chemistry,
conduct repeatedly over a period of shall run consecutively to the periods of Manufacturing, and Control
almost 2 years. Her convictions indicate debarment for health care fraud Information; Guidance for Industry;
that she knowingly and willfully convictions, resulting in a total Request for Comments
disregarded her legal and professional debarment period of 6 years. AGENCY: Food and Drug Administration,
obligations to keep accurate medical As a result of the foregoing findings, HHS.
records and to submit accurate claims Odalys Fernandez is debarred for 6
ACTION: Notice; requests for comments.
for the services she provided. Having years from providing services in any
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![Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 17051
SUMMARY: The Food and Drug In the Federal Register of February Management (see ADDRESSES). It is only
Administration (FDA) is announcing a 21, 2012 (77 FR 9947), FDA announced necessary to send one set of comments.
request for additional comments on the the publication of a final guidance Identify comments with the docket
chemistry, manufacturing, and control entitled ‘‘Early Clinical Trials with Live number found in brackets in the
(CMC) information that a sponsor of an Biotherapeutic Products: Chemistry, heading of this document. Received
investigational new drug application Manufacturing, and Control comments may be seen in the Division
(IND) should provide in its IND in order Information; Guidance for Industry,’’ of Dockets Management between 9 a.m.
to meet regulatory requirements when dated February 2012. The guidance and 4 p.m., Monday through Friday, and
commercially available foods or dietary provides IND sponsors with will be posted to the docket at http://
supplements containing live recommendations regarding CMC www.regulations.gov.
biotherapeutic products (LBPs) are used information that should be included in
as investigational new drugs in early IND submissions for early clinical trials IV. Electronic Access
phase clinical trials. The request for with LBPs, including LBPs lawfully Persons with access to the Internet
additional comments on the CMC marketed as foods or dietary may obtain the February 2012 guidance
information is related to the guidance supplements in the United States and at either http://www.fda.gov/Biologics
entitled, ‘‘Early Clinical Trials with Live proposed for clinical uses regulated BloodVaccines/GuidanceCompliance
Biotherapeutic Products: Chemistry, under section 351 of the Public Health RegulatoryInformation/Guidances/
Manufacturing, and Control Service Act (42 U.S.C. 262). The default.htm or http://www.regulations.
Information; Guidance for Industry,’’ guidance also outlines the Drug gov.
dated February 2012 (February 2012 Substance and Drug Product Dated: March 25, 2015.
guidance). information that should be provided in
Leslie Kux,
DATES: Submit either electronic or the CMC section of an IND to meet the
Associate Commissioner for Policy.
written comments on the requested requirements under § 312.23 and to
support proceeding to clinical [FR Doc. 2015–07273 Filed 3–30–15; 8:45 am]
CMC information by May 29, 2015.
evaluation of an LBP in human subjects. BILLING CODE 4164–01–P
ADDRESSES: Submit written requests for
single copies of the February 2012 II. CMC Information
guidance to the Office of FDA is considering modifying the DEPARTMENT OF HEALTH AND
Communication, Outreach and February 2012 guidance to address the HUMAN SERVICES
Development, Center for Biologics CMC information that should be
Evaluation and Research (CBER), Food provided in an IND, under certain Food and Drug Administration
and Drug Administration, 10903 New conditions. Specifically, FDA is [Docket No. FDA–2014–D–1439]
Hampshire Ave., Bldg. 71, rm. 3128, considering whether to revise the
Silver Spring, MD 20993–0002. Send guidance to address when the label on Critical Path Innovation Meetings;
one self-addressed adhesive label to the commercially available product(s) Guidance for Industry; Availability
assist the office in processing your would be considered adequate to satisfy
requests. The guidance may also be AGENCY: Food and Drug Administration,
the requirement for CMC information
obtained by mail by calling CBER at 1– HHS.
under § 312.23. For example, we are
800–835–4709 or 240–402–7800. See considering whether the label would be ACTION: Notice.
the SUPPLEMENTARY INFORMATION section adequate to satisfy the CMC information
for electronic access to the guidance SUMMARY: The Food and Drug
when the following conditions are met: Administration (FDA) is announcing the
document. (1) The LBP product that is proposed for
Submit electronic comments on the availability of a guidance for industry
investigational use is a commercially
requested CMC information to http:// entitled ‘‘Critical Path Innovation
available food or dietary supplement; (2)
www.regulations.gov. Submit written Meetings.’’ This guidance describes a
the investigation does not involve a
comments to the Division of Dockets Critical Path Innovation Meeting
route of administration, dose, patient
Management (HFA–305), Food and Drug (CPIM), a means by which FDA’s Center
population, or other factor that
Administration, 5630 Fishers Lane, Rm. for Drug Evaluation and Research
significantly increases the risk (or
1061, Rockville, MD 20852. (CDER) and investigators from industry,
decreases the acceptability of risk)
FOR FURTHER INFORMATION CONTACT:
academia, government, and patient
associated with the use of the food or
Jessica T. Walker, Center for Biologics advocacy groups can communicate to
dietary supplement; (3) the investigation
Evaluation and Research, Food and improve efficiency and success in drug
is not intended to support a marketing
Drug Administration, 10903 New development. The goals of the CPIM are
application for a drug claim for the food
Hampshire Ave., Bldg. 71, Rm. 7301, to discuss a methodology or technology
or dietary supplement; and (4) the
Silver Spring, MD 20993–0002, 240– proposed by the meeting requester and
investigation is conducted in
402–7911. for CDER to provide general advice on
compliance with the requirements for
how this methodology or technology
SUPPLEMENTARY INFORMATION: INDs (part 312), the requirements for
might enhance drug development. The
review by an institutional review board
I. Background discussions and background
(21 CFR part 56), and with the
FDA is announcing a request for information submitted through the
requirements for informed consent (21
additional comments on the CMC CPIM are nonbinding on both FDA and
asabaliauskas on DSK5VPTVN1PROD with NOTICES
CFR part 50). FDA is seeking public
information that a sponsor of an IND CPIM requesters.
comment on this issue.
should provide in its IND in order to DATES: Submit either electronic or
meet the requirements under § 312.23 III. Comments written comments on Agency guidances
(21 CFR 312.23), when commercially Interested persons may submit either at any time.
available foods or dietary supplements electronic comments regarding the ADDRESSES: Submit written requests for
containing LBPs are subject to study as requested CMC information to http:// single copies of this guidance to the
investigational new drugs in early phase www.regulations.gov or written Division of Drug Information, Center for
clinical trials. comments to the Division of Dockets Drug Evaluation and Research, Food
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Document Created: 2015-12-18 11:48:19
Document Modified: 2015-12-18 11:48:19
| 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; requests for comments. | |
| Dates | Submit either electronic or written comments on the requested CMC information by May 29, 2015. | |
| Contact | Jessica T. Walker, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 80 FR 17050 |
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