Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Guidance for Industry; Availability, 11305-11307 [2019-05760]
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11305
Federal Register / Vol. 84, No. 58 / Tuesday, March 26, 2019 / Notices
clarification. OHS developed the form to
assist grantees in meeting Head Start
record keeping requirements for
eligibility determination records.
However, Head Start programs are not
required to use this specific form.
Programs may either adopt the form or
design a new form to meet the eligibility
requirements.
Respondents: Head Start and Early
Head Start program grant recipients.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total
burden hours
Eligibility Verification Form ...............................................................................
1,574
428
.025
16,842
Estimated Total Annual Burden
Hours: 16,842.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW, Washington, DC 20201.
Attention Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV. Attn:
Desk Officer for the Administration for
Children and Families.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–05743 Filed 3–25–19; 8:45 am]
BILLING CODE 4184–40–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB No.: 0970–0207]
Submission for OMB Review;
Comment Request
Description: The Office of Head Start
is proposing to renew, with changes, the
Head Start Grant Application, which
grantees use to provide information that
is requested from all Head Start and
Early Head Start grantees applying for
their annual funding. The application
and budget forms are available in the
Head Start Enterprise System (HSES), a
secure web-based system, which
transmits completed applications to
Regional and Central Offices. Changes
are minor and consist of updated fields
and guidance in HSES to accommodate
submission of documentation that
resulted from changes to the Head Start
Program Performance Standards.
Respondents: Head Start and Early
Head Start grantees.
Title: Head Start Grant Application
jbell on DSK30RV082PROD with NOTICES
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden
hours per
response
Total burden
hours
Head Start Grant Application ...........................................................................
2,160
1
33
71,280
Estimated Total Annual Burden
Hours: 71,280.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW, Washington, DC 20201.
Attention Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
VerDate Sep<11>2014
18:45 Mar 25, 2019
Jkt 247001
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Mary B. Jones,
ACF/OPRE Certifying Officer.
Standards Development and the Use of
Standards in Regulatory Submissions
Reviewed in the Center for Biologics
Evaluation and Research; Guidance for
Industry; Availability
[FR Doc. 2019–05738 Filed 3–25–19; 8:45 am]
BILLING CODE 4184–40–P
PO 00000
Food and Drug Administration
[Docket No. FDA–2017–D–6535]
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 final
guidance entitled ‘‘Standards
Development and the Use of Standards
in Regulatory Submissions Reviewed in
Frm 00027
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26MRN1
11306
Federal Register / Vol. 84, No. 58 / Tuesday, March 26, 2019 / Notices
the Center for Biologics Evaluation and
Research; Guidance for Industry.’’ The
guidance document provides the
recommendations of the Center for
Biologics Evaluation and Research
(CBER) on the use of standards in
product development and control as
well as the use of such standards in
CBER’s managed review process. CBER
recognizes the value of standards and
encourages the use of appropriate
standards in the development and
control of CBER-regulated medical
products. Sponsors’ use of standards
can facilitate product development and
provide a more efficient evaluation of
regulatory submissions. The guidance
announced in this notice finalizes the
draft guidance of the same title dated
December 2017.
DATES: The announcement of the
guidance is published in the Federal
Register on March 26, 2019.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances 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’’).
jbell on DSK30RV082PROD with NOTICES
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.
VerDate Sep<11>2014
17:54 Mar 25, 2019
Jkt 247001
• 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–
2017–D–6535 for ‘‘Standards
Development and the Use of Standards
in Regulatory Submissions Reviewed in
the Center for Biologics Evaluation and
Research; Guidance for Industry.’’
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 00028
Fmt 4703
Sfmt 4703
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 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:
Jonathan McKnight, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 301–
796–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Standards
Development and the Use of Standards
in Regulatory Submissions Reviewed in
the Center for Biologics Evaluation and
Research; Guidance for Industry.’’ The
purpose of this guidance is to describe
the recommendations of CBER on the
use of standards in product
development and control as well as the
use of such standards in CBER’s
managed review process. CBER
recognizes the value of standards and
encourages the use of appropriate
standards in the development and
control of CBER-regulated medical
products. Sponsors’ use of standards
can facilitate product development and
provide a more efficient evaluation of
regulatory submissions. This guidance
does not endorse the activities of
specific Standards Development
Organizations or recommend specific
standards for use in regulatory
submissions.
In the Federal Register of December
19, 2017 (82 FR 60204), FDA announced
the availability of the draft guidance of
the same title dated December 2017.
FDA received several comments on the
draft guidance, and those comments
were considered as the guidance was
finalized. Editorial changes were made
to improve clarity. The guidance
announced in this notice finalizes the
draft guidance dated December 2017.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
E:\FR\FM\26MRN1.SGM
26MRN1
Federal Register / Vol. 84, No. 58 / Tuesday, March 26, 2019 / Notices
The guidance represents the current
thinking of FDA on ‘‘Standards
Development and the Use of Standards
in Regulatory Submissions Reviewed in
the Center for Biologics Evaluation and
Research.’’ 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. This guidance is not
subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This 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
21 CFR part 312 have been approved
under OMB control number 0910–0014;
the collections of information in 21 CFR
part 314 have been approved under
OMB control number 0910–0001; and
the collections of information in 21 CFR
part 601 have been approved under
OMB control number 0910–0338.
Electronic Submissions
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: March 20, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–05760 Filed 3–25–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0031]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Clinical Laboratory
Improvement Amendments Waiver
Applications
AGENCY:
Food and Drug Administration,
HHS.
jbell on DSK30RV082PROD with NOTICES
ACTION:
Notice.
SUMMARY: 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
VerDate Sep<11>2014
17:54 Mar 25, 2019
Jkt 247001
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on collections of
information associated with Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) waiver applications.
DATES: Submit either electronic or
written comments on the collection of
information by May 28, 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 May 28, 2019.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 28, 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.
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
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
11307
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–
2008–D–0031 for ‘‘CLIA Waiver
Applications.’’ 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.
E:\FR\FM\26MRN1.SGM
26MRN1
]]>Agencies
[Federal Register Volume 84, Number 58 (Tuesday, March 26, 2019)]
[Notices]
[Pages 11305-11307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05760]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-6535]
Standards Development and the Use of Standards in Regulatory
Submissions Reviewed in the Center for Biologics Evaluation and
Research; 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 final guidance entitled ``Standards Development
and the Use of Standards in Regulatory Submissions Reviewed in
[[Page 11306]]
the Center for Biologics Evaluation and Research; Guidance for
Industry.'' The guidance document provides the recommendations of the
Center for Biologics Evaluation and Research (CBER) on the use of
standards in product development and control as well as the use of such
standards in CBER's managed review process. CBER recognizes the value
of standards and encourages the use of appropriate standards in the
development and control of CBER-regulated medical products. Sponsors'
use of standards can facilitate product development and provide a more
efficient evaluation of regulatory submissions. The guidance announced
in this notice finalizes the draft guidance of the same title dated
December 2017.
DATES: The announcement of the guidance is published in the Federal
Register on March 26, 2019.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2017-D-6535 for ``Standards Development and the Use of Standards in
Regulatory Submissions Reviewed in the Center for Biologics Evaluation
and Research; Guidance for Industry.'' 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 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: Jonathan McKnight, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
301-796-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled
``Standards Development and the Use of Standards in Regulatory
Submissions Reviewed in the Center for Biologics Evaluation and
Research; Guidance for Industry.'' The purpose of this guidance is to
describe the recommendations of CBER on the use of standards in product
development and control as well as the use of such standards in CBER's
managed review process. CBER recognizes the value of standards and
encourages the use of appropriate standards in the development and
control of CBER-regulated medical products. Sponsors' use of standards
can facilitate product development and provide a more efficient
evaluation of regulatory submissions. This guidance does not endorse
the activities of specific Standards Development Organizations or
recommend specific standards for use in regulatory submissions.
In the Federal Register of December 19, 2017 (82 FR 60204), FDA
announced the availability of the draft guidance of the same title
dated December 2017. FDA received several comments on the draft
guidance, and those comments were considered as the guidance was
finalized. Editorial changes were made to improve clarity. The guidance
announced in this notice finalizes the draft guidance dated December
2017.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115).
[[Page 11307]]
The guidance represents the current thinking of FDA on ``Standards
Development and the Use of Standards in Regulatory Submissions Reviewed
in the Center for Biologics Evaluation and Research.'' 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. This guidance
is not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This 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 21 CFR part 312 have been approved under
OMB control number 0910-0014; the collections of information in 21 CFR
part 314 have been approved under OMB control number 0910-0001; and the
collections of information in 21 CFR part 601 have been approved under
OMB control number 0910-0338.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: March 20, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-05760 Filed 3-25-19; 8:45 am]
BILLING CODE 4164-01-P
