Hypertension: Conducting Studies of Drugs To Treat Patients on a Background of Multiple Antihypertensive Drugs; Draft Guidance for Industry; Availability, 32878-32880 [2018-15092]
Download as PDF
<![CDATA[
32878
Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section/activity
511.1(b)(4); submission of NCIE .........................................
511.1(b)(5); submission of data to obtain authorization for
the use of edible food products .......................................
511.1(b)(6); submission of any additional information upon
request of FDA .................................................................
511.1(b)(8)(ii); reporting of findings that may suggest significant hazards pertinent to the safety of the new animal drug ...........................................................................
511.1(b)(9); reporting by importers of investigational new
animal drugs for clinical investigational use in animals ...
Total ..............................................................................
1.There
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
104
15.38
1,600
1
1,600
104
0.30
31
8
248
104
0.02
2
1
2
104
0.14
15
2
30
104
0.14
15
8
120
........................
........................
1,663
........................
2,000
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section/activity
511.1(a)(3); maintain records showing the name and post
office address of the expert or expert organization to
whom the new animal drug is shipped and the date,
quantity, and batch or code mark of each shipment and
delivery for a period of 2 years after such shipment or
delivery .............................................................................
511.1(b)(3); maintain records showing the name and post
office address of the expert or expert organization to
whom the new animal drug or feed containing same is
shipped and the date, quantity, and batch or code mark
of each shipment and delivery for a period of 2 years
after such shipment or delivery ........................................
511.1(b)(7); maintain records of the investigation, including
records of the receipt and disposition of each shipment
or delivery of the investigational new animal drug ..........
511.1(b)(8)(i); maintain records of all reports received by a
sponsor from investigators ...............................................
Total ..............................................................................
sradovich on DSK3GMQ082PROD with NOTICES
1.There
Number of
records
per
recordkeeper
Average
burden
per
recordkeeping
Total
annual
records
Total
hours
104
2.5
260
1
260
104
15.38
1,600
1
1,600
104
15.38
1,600
3.5
5,600
104
15.38
1,600
3.5
5,600
........................
........................
5,060
........................
13,060
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the time required for
reporting requirements, record
preparation, and maintenance for this
collection of information is based on our
informal communication with industry.
Based on the number of sponsors
subject to animal drug user fees, we
estimate that there are 104 respondents.
We use this estimate consistently
throughout the table and calculate the
‘‘number of responses per respondent’’
by dividing the total annual responses
by number of respondents. Additional
information needed to make a final
calculation of the total burden hours
(i.e., the number of respondents, the
number of recordkeepers, the number of
NCIEs received, etc.) is derived from our
records. The burden for this information
collection has changed since the last
OMB approval. We estimate an overall
increase in burden that we attribute to
VerDate Sep<11>2014
17:31 Jul 13, 2018
Jkt 244001
an increase in the number of annual
responses and records.
Dated: July 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–15087 Filed 7–13–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–2515]
Hypertension: Conducting Studies of
Drugs To Treat Patients on a
Background of Multiple
Antihypertensive Drugs; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Hypertension: Conducting Studies of
Drugs to Treat Patients on a Background
of Multiple Antihypertensive Drugs.’’
This draft guidance is intended to
clarify the recommended approach for
sponsors developing drugs to treat
hypertension for patients who are on a
background of multiple
antihypertensive drugs.
DATES: Submit either electronic or
written comments on the draft guidance
by September 14, 2018 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:
E:\FR\FM\16JYN1.SGM
16JYN1
Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / 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’’).
sradovich on DSK3GMQ082PROD 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.
• 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–
2018–D–2515 for ‘‘Hypertension:
Conducting Studies of Drugs to Treat
Patients on a Background of Multiple
Antihypertensive Drugs; Draft Guidance
for Industry; Availability.’’ 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
VerDate Sep<11>2014
17:31 Jul 13, 2018
Jkt 244001
32879
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.
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. 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:
Stephen Grant, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4160,
Silver Spring, MD 20903, 301–796–
2240.
Drugs to Treat Patients on a Background
of Multiple Antihypertensive Drugs.’’
This draft guidance is intended to
clarify the recommended approach for
sponsors developing drugs to treat
hypertension for patients who are on a
background of multiple
antihypertensive drugs. Sponsors have
approached FDA to discuss
development programs for drugs
intended to treat resistant hypertension,
which sponsors have defined as
hypertension not adequately controlled
by maximally tolerated doses of three or
more antihypertensive drugs with
different mechanisms of action. FDA
encourages development of additional
classes of drugs for hypertension,
particularly classes of drugs that
demonstrate effects when added to
currently available therapies.
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 conducting studies of drugs to treat
hypertension in patients on a
background of multiple
antihypertensive drugs. 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.
SUPPLEMENTARY INFORMATION:
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Hypertension: Conducting Studies of
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information that
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 collection of
information in the guidance for industry
entitled ‘‘Hypertension Indication: Drug
Labeling for Cardiovascular Outcome
Claims’’ (available at https://
www.fda.gov/ucm/groups/fdagovpublic/@fdagov-drugs-gen/documents/
document/ucm075072.pdf) has been
approved under OMB control number
0910–0670.
III. Electronic Access
E:\FR\FM\16JYN1.SGM
16JYN1
32880
Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices
Dated: July 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
collection of information to OMB for
review and clearance.
Petition To Request an Exemption From
100 Percent Identity Testing of Dietary
Ingredients: Current Good
Manufacturing Practice in
Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
Supplements—21 CFR 111.75(a)(1)(ii)
[FR Doc. 2018–15092 Filed 7–13–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
OMB Control Number 0910–0608—
Extension
[Docket No. FDA–2018–N–1011]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Petition To
Request an Exemption From 100
Percent Identity Testing of Dietary
Ingredients: Current Good
Manufacturing Practice in
Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
Supplements
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 August 15,
2018.
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
OMB control number 0910–0608. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
sradovich on DSK3GMQ082PROD with NOTICES
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:31 Jul 13, 2018
Jkt 244001
This information collection supports
Agency regulations. The Dietary
Supplement Health and Education Act
(Pub. L. 103–417) added section 402(g)
of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 342(g)),
which provides, in part, that the
Secretary of Health and Human Services
may, by regulation, prescribe good
manufacturing practices for dietary
supplements. Section 402(g)(1) of the
FD&C Act states that a dietary
supplement is adulterated if it has been
prepared, packed, or held under the
types of conditions that do not meet
current good manufacturing practice
regulations. Section 701(a) of the FD&C
Act (21 U.S.C. 371(a)) gives us the
authority to issue regulations for the
efficient enforcement of the FD&C Act.
Part 111 (21 CFR part 111) establishes
the minimum Current Good
Manufacturing Practice (CGMP)
necessary for activities related to
manufacturing, packaging, labeling, or
holding dietary supplements to ensure
the quality of the dietary supplement.
Section 111.75(a)(1) of our regulations
(21 CFR 111.75(a)(1)) establishes a
procedure for a petition to request an
exemption from 100 percent identity
testing of dietary ingredients. Under
§ 111.75(a)(1)(ii), manufacturers may
request an exemption from the
requirements set forth in
§ 111.75(a)(1)(i) when the dietary
ingredient is obtained from one or more
suppliers identified in the petition. The
regulation clarifies that we are willing to
consider, on a case-by-case basis, a
manufacturer’s conclusion, supported
by appropriate data and information in
the petition submission, that it has
developed a system that it would
implement as a sound, consistent means
of establishing, with no material
diminution of assurance compared to
the assurance provided by 100 percent
identity testing, the identity of the
dietary ingredient before use.
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Section 111.75(a)(1) reflects our
determination that manufacturers that
test or examine 100 percent of the
incoming dietary ingredients for
identity can be assured of the identity
of the ingredient. However, we
recognize that it may be possible for a
manufacturer to demonstrate, through
various methods and processes in use
over time for its particular operation,
that a system of less than 100 percent
identity testing would result in no
material diminution of assurance of the
identity of the dietary ingredient as
compared to the assurance provided by
100 percent identity testing. To provide
an opportunity for a manufacturer to
make such a showing and reduce the
frequency of identity testing of
components that are dietary ingredients
from 100 percent to some lower
frequency, we added to § 111.75(a)(1),
an exemption from the requirement of
100 percent identity testing when a
manufacturer petitions the Agency for
such an exemption to 100 percent
identity testing under § 10.30 (21 CFR
10.30) and the Agency grants such
exemption. Such a procedure would be
consistent with our stated goal, as
described in the CGMP final rule, of
providing flexibility in the CGMP
requirements. Section 111.75(a)(1)(ii)
sets forth the information a
manufacturer is required to submit in
such a petition. The regulation also
contains a requirement to ensure that
the manufacturer keeps our response to
a petition submitted under
§ 111.75(a)(1)(ii) as a record under
§ 111.95 (21 CFR 111.95). The collection
of information in § 111.95 has been
approved under OMB control number
0910–0606.
In the Federal Register of April 9,
2018 (83 FR 15159), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was received
suggesting that ‘‘microbial cultures and
probiotics should not be required to go
through such a process to ensure
exemption from the Agency’s 100
percent identity testing requirement,’’
but did not suggest a revision to the
estimated burden. We appreciate this
comment, however, we believe that the
current requirements impose minimal
information collection while
simultaneously ensuring the safety of
dietary supplements.
We estimate the burden of the
information collection as follows:
E:\FR\FM\16JYN1.SGM
16JYN1
]]>Agencies
[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Notices]
[Pages 32878-32880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15092]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-2515]
Hypertension: Conducting Studies of Drugs To Treat Patients on a
Background of Multiple Antihypertensive Drugs; Draft 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 draft guidance for industry entitled
``Hypertension: Conducting Studies of Drugs to Treat Patients on a
Background of Multiple Antihypertensive Drugs.'' This draft guidance is
intended to clarify the recommended approach for sponsors developing
drugs to treat hypertension for patients who are on a background of
multiple antihypertensive drugs.
DATES: Submit either electronic or written comments on the draft
guidance by September 14, 2018 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:
[[Page 32879]]
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-2018-D-2515 for ``Hypertension: Conducting Studies of Drugs to
Treat Patients on a Background of Multiple Antihypertensive Drugs;
Draft Guidance for Industry; Availability.'' 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. 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: Stephen Grant, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4160, Silver Spring, MD 20903, 301-796-
2240.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Hypertension: Conducting Studies of Drugs to Treat Patients
on a Background of Multiple Antihypertensive Drugs.'' This draft
guidance is intended to clarify the recommended approach for sponsors
developing drugs to treat hypertension for patients who are on a
background of multiple antihypertensive drugs. Sponsors have approached
FDA to discuss development programs for drugs intended to treat
resistant hypertension, which sponsors have defined as hypertension not
adequately controlled by maximally tolerated doses of three or more
antihypertensive drugs with different mechanisms of action. FDA
encourages development of additional classes of drugs for hypertension,
particularly classes of drugs that demonstrate effects when added to
currently available therapies.
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 conducting
studies of drugs to treat hypertension in patients on a background of
multiple antihypertensive drugs. 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 that 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 collection of
information in the guidance for industry entitled ``Hypertension
Indication: Drug Labeling for Cardiovascular Outcome Claims''
(available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm075072.pdf) has been approved under OMB
control number 0910-0670.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
[[Page 32880]]
Dated: July 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15092 Filed 7-13-18; 8:45 am]
BILLING CODE 4164-01-P
