Fabry Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability, 38994-38996 [2019-16994]
Download as PDF
38994
Federal Register / Vol. 84, No. 153 / Thursday, August 8, 2019 / Notices
Food and Drug Administration
OMB control number 0910–0601. Also
include the FDA docket number found
in brackets in the heading of this
document.
[Docket No. FDA–2010–N–0414]
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Manufactured
Food Regulatory Program Standards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by September
9, 2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
SUMMARY:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Manufactured Food Regulatory
Program Standards
OMB Control Number 0910–0601—
Extension
In the Federal Register of July 20,
2006 (71 FR 41221), FDA announced the
availability of a document entitled
‘‘Manufactured Food Regulatory
Program Standards.’’ These program
standards are the framework that States
should use to design and manage their
manufactured food programs. There are
43 State programs enrolled, which
receive an average of $230,000
(maximum of $300,000) each year for a
period of 5 years from the year they first
enroll, provided there is significant
conformance with and/or maintenance
of the 10 standards.
In the first year of implementing the
program standards, the State program
conducts a baseline self-assessment to
determine if it meets the elements of
each standard. FDA suggests that the
State program use the worksheets and
forms contained in the draft program
standards; however, it can use alternate
forms that are equivalent. The State
program maintains the documents and
verifies records required for each
standard. The information contained in
the documents must be current and fit
for use. If the State program fails to meet
all program elements and
documentation requirements of a
standard, it develops a strategic plan
which includes the following: (1) The
individual element of documentation
requirement of the standard that was not
met, (2) improvements needed to meet
the program element or documentation
requirement of the standard, and (3)
projected completion dates for each
task.
In the Federal Register of April 17,
2019 (84 FR 16020), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Respondent
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden
per
response
Total hours
State Departments of Agriculture or Health ........................
43
1
43
569
24,467
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Respondent
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden
per recordkeeping
Total hours
State Departments of Agriculture or Health ........................
43
10
430
40
17,200
jbell on DSK3GLQ082PROD with NOTICES
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
One additional State has enrolled in
the program since 2016. The total
estimated burden of this collection has
increased to 41,667 hours among 43
respondents, from a previous total of
15,792 hours among 42 respondents.
This increase is due to a change in the
self-reported response times provided
by the respondents. Because this is a
long-term program, we believe this
change is the result of more precise
documentation by participating agencies
VerDate Sep<11>2014
16:51 Aug 07, 2019
Jkt 247001
as they have grown more experienced
over time.
Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–2973]
[FR Doc. 2019–16937 Filed 8–7–19; 8:45 am]
Fabry Disease: Developing Drugs for
Treatment; Draft Guidance for
Industry; Availability
BILLING CODE 4164–01–P
PO 00000
AGENCY:
Food and Drug Administration,
HHS.
Frm 00068
Fmt 4703
Sfmt 4703
E:\FR\FM\08AUN1.SGM
08AUN1
Federal Register / Vol. 84, No. 153 / Thursday, August 8, 2019 / Notices
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Fabry
Disease: Developing Drugs for
Treatment.’’ This draft guidance
describes the Agency’s current
recommendations regarding eligibility
criteria, trial design considerations, and
efficacy endpoints to be used in clinical
development programs of
investigational drugs to treat Fabry
disease. Through this draft guidance,
the Agency provides clear and specific
guidance to foster greater efficiency in
drug development in this rare disease
with the goal of enhancing clinical trial
data quality and supporting the
development of treatments for Fabry
disease.
DATES: Submit either electronic or
written comments on the draft guidance
by November 6, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
jbell on DSK3GLQ082PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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): Dockets
Management Staff (HFA–305), Food and
VerDate Sep<11>2014
16:51 Aug 07, 2019
Jkt 247001
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2019–D–2973 for ‘‘Fabry Disease:
Developing Drugs for Treatment.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff 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
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. 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: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
38995
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or the Office of Communication,
Outreach, and Development, Center for
Biologics Evaluation and Research,
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 that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Jeannie Roule, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5332,
Silver Spring, MD 20993–0002, 301–
796–3993; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Fabry Disease: Developing Drugs for
Treatment.’’ This draft guidance
describes the Agency’s
recommendations regarding the
structure of clinical development
programs for drugs intended to treat
Fabry disease. The draft guidance is
intended to facilitate greater consistency
in approaches among development
programs and to ensure that sponsors
receive clear and specific guidance to
foster greater efficiency of drug
development in this rare disease. The
draft guidance describes specific
considerations relating to eligibility
criteria and trial design and discusses
the Agency’s current recommendations
for efficacy endpoints that can be used
to support approval of drugs for Fabry
disease.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Fabry Disease: Developing Drugs for
Treatment.’’ 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
E:\FR\FM\08AUN1.SGM
08AUN1
38996
Federal Register / Vol. 84, No. 153 / Thursday, August 8, 2019 / Notices
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This draft 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 under 21 CFR part 312
(Investigational New Drug Application)
have been approved under OMB control
number 0910–0014. The collections of
information in 21 CFR parts 50 and 56
(Protection of Human Subjects:
Informed Consent; Institutional Review
Boards) have been approved under OMB
control number 0910–0755.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, or https://
www.regulations.gov.
Dated: August 5, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16994 Filed 8–7–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3018]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Healthcare
Provider Perception of Boxed Warning
Information Survey
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on Healthcare
jbell on DSK3GLQ082PROD with NOTICES
SUMMARY:
16:51 Aug 07, 2019
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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
Notice.
VerDate Sep<11>2014
Provider Perception of Boxed Warning
Information Survey.
DATES: Submit either electronic or
written comments on the collection of
information by October 7, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before October 7,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of October 7, 2019. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Jkt 247001
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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.’’
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–3018 for ‘‘Healthcare Provider
Perception of Boxed Warning
Information Survey.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff 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
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. 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: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
E:\FR\FM\08AUN1.SGM
08AUN1
Agencies
[Federal Register Volume 84, Number 153 (Thursday, August 8, 2019)]
[Notices]
[Pages 38994-38996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16994]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-2973]
Fabry Disease: Developing Drugs for Treatment; Draft Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
[[Page 38995]]
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Fabry
Disease: Developing Drugs for Treatment.'' This draft guidance
describes the Agency's current recommendations regarding eligibility
criteria, trial design considerations, and efficacy endpoints to be
used in clinical development programs of investigational drugs to treat
Fabry disease. Through this draft guidance, the Agency provides clear
and specific guidance to foster greater efficiency in drug development
in this rare disease with the goal of enhancing clinical trial data
quality and supporting the development of treatments for Fabry disease.
DATES: Submit either electronic or written comments on the draft
guidance by November 6, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2019-D-2973 for ``Fabry Disease: Developing Drugs for Treatment.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, 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 that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Jeannie Roule, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5332, Silver Spring, MD 20993-0002, 301-
796-3993; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Fabry Disease: Developing Drugs for Treatment.'' This draft
guidance describes the Agency's recommendations regarding the structure
of clinical development programs for drugs intended to treat Fabry
disease. The draft guidance is intended to facilitate greater
consistency in approaches among development programs and to ensure that
sponsors receive clear and specific guidance to foster greater
efficiency of drug development in this rare disease. The draft guidance
describes specific considerations relating to eligibility criteria and
trial design and discusses the Agency's current recommendations for
efficacy endpoints that can be used to support approval of drugs for
Fabry disease.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Fabry
Disease: Developing Drugs for Treatment.'' 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
[[Page 38996]]
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This draft 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 under 21 CFR part 312 (Investigational New
Drug Application) have been approved under OMB control number 0910-
0014. The collections of information in 21 CFR parts 50 and 56
(Protection of Human Subjects: Informed Consent; Institutional Review
Boards) have been approved under OMB control number 0910-0755.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, or
https://www.regulations.gov.
Dated: August 5, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16994 Filed 8-7-19; 8:45 am]
BILLING CODE 4164-01-P