81 FR 43206 - Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 127 (July 1, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 127 (July 1, 2016)
| Page Range | 43206-43207 | |
| FR Document | 2016-15664 |
[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)] [Notices] [Pages 43206-43207] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-15664] ----------------------------------------------------------------------- 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; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry.'' The guidance document provides investigational new drug application (IND) sponsors with recommendations regarding IND submissions for early clinical trials with live biotherapeutic products (LBPs) in the United States. The guidance announced in this notice updates the guidance of the same title dated February 2012 (February 2012 guidance) by addressing when the label on the commercially available products(s) would be considered adequate to satisfy the purpose of the chemistry, manufacturing, and control (CMC) information requirements. DATES: Submit either electronic or written comments on Agency 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-0500 for ``Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry.'' 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 [[Page 43207]] Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential 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. Submit written requests for single copies of the 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 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. 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 the availability of a document entitled ``Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry.'' The guidance provides IND sponsors with recommendations regarding IND submissions for early clinical trials for LBPs in the United States, including LBPs lawfully marketed as conventional foods and dietary supplements in the United States and proposed for clinical uses regulated under section 351 of the Public Health Service (PHS) Act (42 U.S.C. 262). The guidance focuses on the CMC information that should be provided in an IND for early clinical trials evaluating LBPs. The guidance is applicable to INDs of LBPs, whether clinical trials are conducted commercially, in an academic setting, or otherwise under part 312 (21 CFR part 312). In the Federal Register of February 21, 2012 (77 FR 9947), FDA announced the availability of the final guidance of the same title dated February 2012. In the Federal Register of March 31, 2015 (80 FR 17050), FDA published a notice requesting additional comments on the CMC information that a sponsor of an IND should provide in its IND in order to meet regulatory requirements when commercially available conventional foods or dietary supplements containing LBPs are used as investigational new drugs in early phase clinical trials. FDA received a few comments on the notice and in response to the comments, FDA is updating the February 2012 guidance by adding a section to address when the label on commercially available products will be considered adequate to satisfy the purpose of the CMC requirements for INDs under Sec. 312.23(a)(7)(iv)(a)-(b). In addition, editorial changes were made to improve clarity. The guidance announced in this notice updates the guidance of the same title dated February 2012. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(2) without seeking additional comments after determining that prior public participation is not feasible or appropriate. FDA notes that we already sought comments on the issues addressed by the revisions in this guidance in the Federal Register of March 31, 2015 under Docket No. FDA-2010-D-0500. Further delay in implementing these revisions could impede the progress of certain investigations of drug use of commercially marketed foods or dietary supplements that are of low risk and may be of benefit to the public health. The guidance represents the current thinking of FDA on ``Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information.'' It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 The guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 312 have been approved under OMB control number 0910-0014. III. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: June 27, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-15664 Filed 6-30-16; 8:45 am] BILLING CODE 4164-01-P
![43206 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Number of burden per Total burden
Respondents Form name responses per
respondents response hours
respondent (in hours)
Consumer Concept Testing In-depth Interview 68 1 1 68
Guide.
Consumer Materials Testing In-depth Interview 68 1 1 68
Guide.
Exploratory—HIV Testing Focus Group Inter- 74 1 2 148
view Guide.
Exploratory—HIV Prevention Focus Group Inter- 74 1 2 148
view Guide.
Exploratory—HIV Communication and Aware- 74 1 2 148
ness Focus Group Interview Guide.
Exploratory—HIV Prevention with Positives 74 1 2 148
Focus Group Interview Guide.
Consumer Concept Testing Focus Group Inter- 68 1 2 136
view Guide.
Consumer Message Testing Focus Group Inter- 68 1 2 136
view Guide.
Consumer Materials Testing Focus Group Inter- 68 1 2 136
view Guide.
HIV Testing Survey ............................................. 250 1 15/60 63
HIV Prevention Survey ........................................ 250 1 15/60 63
HIV Communication and Awareness Survey ...... 250 1 15/60 63
HIV Prevention with Positives Survey ................. 250 1 15/60 63
Intercept Interview Guide .................................... 700 1 20/60 233
Total ........................ .............................................................................. ........................ ........................ ........................ 2,063
Jeffrey M. Zirger, products (LBPs) in the United States. identifies you in the body of your
Health Scientist, Acting Chief, Information The guidance announced in this notice comments, that information will be
Collection Review Office, Office of Scientific updates the guidance of the same title posted on http://www.regulations.gov.
Integrity, Office of the Associate Director for dated February 2012 (February 2012 • If you want to submit a comment
Science, Office of the Director, Centers for guidance) by addressing when the label with confidential information that you
Disease Control and Prevention. on the commercially available do not wish to be made available to the
[FR Doc. 2016–15646 Filed 6–30–16; 8:45 am] products(s) would be considered public, submit the comment as a
BILLING CODE 4163–18–P adequate to satisfy the purpose of the written/paper submission and in the
chemistry, manufacturing, and control manner detailed (see ‘‘Written/Paper
(CMC) information requirements. Submissions’’ and ‘‘Instructions’’).
DEPARTMENT OF HEALTH AND
DATES: Submit either electronic or Written/Paper Submissions
HUMAN SERVICES
written comments on Agency guidances
Submit written/paper submissions as
Food and Drug Administration at any time. follows:
[Docket No. FDA–2010–D–0500]
ADDRESSES: You may submit comments • Mail/Hand delivery/Courier (for
as follows: written/paper submissions): Division of
Early Clinical Trials With Live Electronic Submissions Dockets Management (HFA–305), Food
Biotherapeutic Products: Chemistry, and Drug Administration, 5630 Fishers
Submit electronic comments in the Lane, Rm. 1061, Rockville, MD 20852.
Manufacturing, and Control
Information; Guidance for Industry;
following way: • For written/paper comments
• Federal eRulemaking Portal: http:// submitted to the Division of Dockets
Availability
www.regulations.gov. Follow the Management, FDA will post your
AGENCY: Food and Drug Administration, instructions for submitting comments. comment, as well as any attachments,
HHS. Comments submitted electronically, except for information submitted,
ACTION: Notice of availability. including attachments, to http:// marked and identified, as confidential,
www.regulations.gov will be posted to if submitted as detailed in
SUMMARY: The Food and Drug the docket unchanged. Because your ‘‘Instructions.’’
Administration (FDA or Agency) is comment will be made public, you are Instructions: All submissions received
announcing the availability of a solely responsible for ensuring that your must include the Docket No. FDA–
document entitled ‘‘Early Clinical Trials comment does not include any 2010–D–0500 for ‘‘Early Clinical Trials
asabaliauskas on DSK3SPTVN1PROD with NOTICES
With Live Biotherapeutic Products: confidential information that you or a With Live Biotherapeutic Products:
Chemistry, Manufacturing, and Control third party may not wish to be posted, Chemistry, Manufacturing, and Control
Information; Guidance for Industry.’’ such as medical information, your or Information; Guidance for Industry.’’
The guidance document provides anyone else’s Social Security number, or Received comments will be placed in
investigational new drug application confidential business information, such the docket and, except for those
(IND) sponsors with recommendations as a manufacturing process. Please note submitted as ‘‘Confidential
regarding IND submissions for early that if you include your name, contact Submissions,’’ publicly viewable at
clinical trials with live biotherapeutic information, or other information that http://www.regulations.gov or at the
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![Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices 43207
Division of Dockets Management FOR FURTHER INFORMATION CONTACT: participation is not feasible or
between 9 a.m. and 4 p.m., Monday Jessica T. Walker, Center for Biologics appropriate. FDA notes that we already
through Friday. Evaluation and Research, Food and sought comments on the issues
• Confidential Submissions—To Drug Administration, 10903 New addressed by the revisions in this
submit a comment with confidential Hampshire Ave., Bldg. 71, Rm. 7301, guidance in the Federal Register of
information that you do not wish to be Silver Spring, MD 20993–0002, 240– March 31, 2015 under Docket No. FDA–
made publicly available, submit your 402–7911. 2010–D–0500. Further delay in
comments only as a written/paper SUPPLEMENTARY INFORMATION: implementing these revisions could
submission. You should submit two impede the progress of certain
I. Background investigations of drug use of
copies total. One copy will include the
FDA is announcing the availability of commercially marketed foods or dietary
information you claim to be confidential a document entitled ‘‘Early Clinical
with a heading or cover note that states supplements that are of low risk and
Trials With Live Biotherapeutic may be of benefit to the public health.
‘‘THIS DOCUMENT CONTAINS Products: Chemistry, Manufacturing, The guidance represents the current
CONFIDENTIAL INFORMATION.’’ The and Control Information; Guidance for thinking of FDA on ‘‘Early Clinical
Agency will review this copy, including Industry.’’ The guidance provides IND Trials with Live Biotherapeutic
the claimed confidential information, in sponsors with recommendations Products: Chemistry, Manufacturing,
its consideration of comments. The regarding IND submissions for early and Control Information.’’ It does not
second copy, which will have the clinical trials for LBPs in the United establish any rights for any person and
claimed confidential information States, including LBPs lawfully is not binding on FDA or the public.
redacted/blacked out, will be available marketed as conventional foods and You can use an alternative approach if
for public viewing and posted on http:// dietary supplements in the United it satisfies the requirements of the
www.regulations.gov. Submit both States and proposed for clinical uses applicable statutes and regulations.
copies to the Division of Dockets regulated under section 351 of the
Management. If you do not wish your Public Health Service (PHS) Act (42 II. Paperwork Reduction Act of 1995
name and contact information to be U.S.C. 262). The guidance focuses on The guidance refers to previously
made publicly available, you can the CMC information that should be approved collections of information
provide this information on the cover provided in an IND for early clinical found in FDA regulations. These
sheet and not in the body of your trials evaluating LBPs. The guidance is collections of information are subject to
comments and you must identify this applicable to INDs of LBPs, whether review by the Office of Management and
information as ‘‘confidential.’’ Any clinical trials are conducted Budget (OMB) under the Paperwork
information marked as ‘‘confidential’’ commercially, in an academic setting, or Reduction Act of 1995 (44 U.S.C. 3501–
will not be disclosed except in otherwise under part 312 (21 CFR part 3520). The collections of information in
accordance with 21 CFR 10.20 and other 312). part 312 have been approved under
applicable disclosure law. For more In the Federal Register of February OMB control number 0910–0014.
information about FDA’s posting of 21, 2012 (77 FR 9947), FDA announced
comments to public dockets, see 80 FR the availability of the final guidance of III. Electronic Access
56469, September 18, 2015, or access the same title dated February 2012. In Persons with access to the Internet
the information at: http://www.fda.gov/ the Federal Register of March 31, 2015 may obtain the guidance at either http://
regulatoryinformation/dockets/ (80 FR 17050), FDA published a notice www.fda.gov/BiologicsBloodVaccines/
default.htm. requesting additional comments on the GuidanceComplianceRegulatory
Docket: For access to the docket to CMC information that a sponsor of an Information/Guidances/default.htm or
read background documents or the IND should provide in its IND in order http://www.regulations.gov.
electronic and written/paper comments to meet regulatory requirements when Dated: June 27, 2016.
received, go to http:// commercially available conventional Leslie Kux,
www.regulations.gov and insert the foods or dietary supplements containing
Associate Commissioner for Policy.
docket number, found in brackets in the LBPs are used as investigational new
[FR Doc. 2016–15664 Filed 6–30–16; 8:45 am]
drugs in early phase clinical trials. FDA
heading of this document, into the BILLING CODE 4164–01–P
received a few comments on the notice
‘‘Search’’ box and follow the prompts
and in response to the comments, FDA
and/or go to the Division of Dockets
is updating the February 2012 guidance
Management, 5630 Fishers Lane, Rm. DEPARTMENT OF HEALTH AND
by adding a section to address when the
1061, Rockville, MD 20852. HUMAN SERVICES
label on commercially available
Submit written requests for single products will be considered adequate to Food and Drug Administration
copies of the guidance to the Office of satisfy the purpose of the CMC
Communication, Outreach and requirements for INDs under [Docket No. FDA–N–2016–1493]
Development, Center for Biologics § 312.23(a)(7)(iv)(a)–(b). In addition,
Evaluation and Research (CBER), Food editorial changes were made to improve Erythropoietic Protoporphyria;
and Drug Administration, 10903 New clarity. The guidance announced in this Scientific Workshop
Hampshire Ave., Bldg. 71, Rm. 3128, notice updates the guidance of the same AGENCY: Food and Drug Administration,
Silver Spring, MD 20993–0002. Send
asabaliauskas on DSK3SPTVN1PROD with NOTICES
title dated February 2012. HHS.
one self-addressed adhesive label to This guidance is being issued ACTION: Notice of public workshop;
assist the office in processing your consistent with FDA’s good guidance request for comments.
requests. The guidance may also be practices regulation (21 CFR 10.115).
obtained by mail by calling CBER at 1– FDA is issuing this guidance for SUMMARY: The Food and Drug
800–835–4709 or 240–402–8010. See immediate implementation in Administration (FDA or Agency) is
the SUPPLEMENTARY INFORMATION section accordance with 21 CFR 10.115(g)(2) announcing a public workshop and an
for electronic access to the guidance without seeking additional comments opportunity for public comment on
document. after determining that prior public Erythropoietic Protoporphyria (EPP).
VerDate Sep<11>2014 19:05 Jun 30, 2016 Jkt 238001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\01JYN1.SGM 01JYN1](https://thefederalregister.org/doc/81_FR_43333/page/2.svg)
Document Created: 2016-07-14 11:37:52
Document Modified: 2016-07-14 11:37:52
| 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 availability. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| 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 | 81 FR 43206 |
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