Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, 28961-28965 [2020-10336]
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TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
disclosures per
respondent
Number of
respondents
Activity; 21 CFR section
Microwave oven safety information and instructions—
1030.10(c)(5)(i) through (iv) .........................................
Microwave oven warning labels—1030.10(c)(6)(iii) .........
Laser products information—1040.10(h)(1)(i) through
(vi) .................................................................................
Laser product service information—1040.10(h)(2)(i) and
(ii) ..................................................................................
Medical laser product instructions—1040.11(a)(2) ..........
Sunlamp products instructions—1040.20 ........................
Mercury vapor lamp labeling—1040.30(c)(1)(ii) ..............
Mercury vapor lamp permanently affixed labels—
1040.30(c)(2) ................................................................
Ultrasonic therapy products—1050.10(d)(1) through (d),
(f)(1), and (f)(2)(iii) ........................................................
Total ..........................................................................
Average
burden per
disclosure
Total annual
disclosures
Total hours 2
1
1
1
1
1
1
20
1
20
1
3
1
3
20
60
3
2
1
1
1
1
1
1
3
2
1
1
20
10
10
1
60
20
10
1
1
1
1
1
1
1
1
1
56
56
........................
............................
........................
........................
3,058
1 There
2 Total
are no capital costs or operating and maintenance costs associated with this collection of information.
hours have been rounded.
Based on a review of the information
collection, we have made no
adjustments to our burden estimate.
Dated: May 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–10373 Filed 5–13–20; 8:45 am]
BILLING CODE 4164–01–P
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0800. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3065]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Human Drug
Compounding Under Sections 503A
and 503B of the Federal Food, Drug,
and Cosmetic Act
AGENCY:
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:
Food and Drug Administration,
HHS.
ACTION:
OMB Control Number 0910–0800—
Revision
Notice.
The Food and Drug
Administration (FDA or we) 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: Submit written comments
(including recommendations) on the
collection of information by June 15,
2020.
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SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
ADDRESSES:
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Human Drug Compounding Under
Sections 503A and 503B of the Federal
Food, Drug, and Cosmetic Act
Jkt 250001
This information collection supports
Agency implementation of sections
503A and 503B of the Federal Food,
Drug, and Cosmetic Act (FD&C Act). For
efficiency of Agency operations, we are
revising the information collection
currently approved under OMB control
number 0910–0800 pertaining to human
drug compounding and section 503B of
the FD&C Act (21 U.S.C. 355b) to
include reference to Agency guidance
regarding section 503A of the FD&C Act
(21 U.S.C. 355a), and to also include
information collection that we attribute
to a final standard memorandum of
understanding (MOU) provided for by
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section 503A (‘‘final standard MOU’’).
Finally, we are revising the title of the
information collection from ‘‘Adverse
Event Reporting for Outsourcing
Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act’’
to ‘‘Human Drug Compounding Under
Sections 503A and 503B of the Federal
Food, Drug, and Cosmetic Act.’’ As
information collection activity is
planned and undertaken by FDA, we
find consolidating related collection
elements better utilizes our resources.
Agency Guidance Regarding Section
503A
We are revising the information
collection to include reference to the
guidance entitled ‘‘Pharmacy
Compounding of Human Drug Products
Under Section 503A of the Federal
Food, Drug, and Cosmetic Act.’’ The
guidance is available from our website
at: https://www.fda.gov/media/94393/
download. The guidance was issued
consistent with our Good Guidance
Practice regulations (21 CFR 10.115),
which provide for comment at any time.
The guidance communicates FDA’s
intention with regard to enforcement of
section 503A of the FD&C Act to
regulate entities that compound drugs
and notes that parts of section 503A
require rulemaking and consultation
with a Pharmacy Compounding
Advisory Committee to implement and
explains how the provisions will be
applied pending those consultations
and rulemaking. Although the guidance
does not include recommended
information collection, we are including
the guidance as a supplemental
reference for respondents.
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The Final Standard MOU
We are also revising the information
collection to include information
collection associated with the standard
MOU pursuant to the provisions of the
Food and Drug Administration
Modernization Act of 1997 (FDAMA)
(Pub. L. 105–115) found in section 503A
of the FD&C Act. Section 503A of the
FD&C Act describes the conditions
under which certain drug products
compounded by a licensed pharmacist
in a State-licensed pharmacy or Federal
facility, or by a licensed physician are
exempt from certain sections of the
FD&C Act. One of the conditions to
qualify for the exemptions listed in
section 503A of the FD&C Act is that: (1)
The drug product is compounded in a
State that has entered into an MOU with
FDA that addresses the distribution of
inordinate amounts of compounded
drug products interstate and provides
for appropriate investigation by a State
agency of complaints relating to
compounded drug products distributed
outside such a State or (2) if the drug
product is compounded in a State that
has not entered into such an MOU, the
licensed pharmacist, licensed
pharmacy, or licensed physician does
not distribute, or cause to be distributed,
compounded drug products out of the
State in which they are compounded, in
quantities that exceed 5 percent of the
total prescription orders dispensed or
distributed by such pharmacy or
physician (see section 503A(b)(3)(B) of
the FD&C Act).
Section 503A(b)(3)(B) of the FD&C Act
directs FDA, in consultation with the
National Association of Boards of
Pharmacy (NABP), to develop a
standard MOU for use by States in
complying with the provision that
references an MOU that addresses the
distribution of inordinate amounts of
compounded drug products interstate
and provides for appropriate
investigation by a State agency of
complaints relating to drug products
compounded in the State and
distributed outside such State.
Accordingly, we have developed the
document entitled, ‘‘Memorandum of
Understanding Addressing Certain
Distributions of Compounded Human
Drug Products Between the [Insert State
Board of Pharmacy or Other
Appropriate State Agency] and the U.S.
Food and Drug Administration,’’
available in docket number FDA–2018–
N–3065, which is available at: https://
www.regulations.gov/docket?D=FDA2018-N-3065.
For purposes of this analysis, FDA
assumes that 45 States will sign the
standard MOU with FDA.
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Under section III.a of the final
standard MOU, the State Board of
Pharmacy (BOP) or other appropriate
State agency will notify FDA by
submission to an information sharing
network or by sending an email to
StateMOU@fda.hhs.gov as soon as
possible, but no later than 5 business
days, after receiving a complaint
relating to a human drug product
compounded at a pharmacy and
distributed outside the State involving a
serious adverse drug experience or
serious product quality issue. The
notification will include the following
information: (1) The name and contact
information of the complainant, if
available; (2) the name and address of
the pharmacy that is the subject of the
complaint; and (3) a description of the
complaint, including a description of
any compounded human drug product
that is the subject of the complaint.
After the State BOP or other appropriate
State agency concludes its investigation
of a complaint assessed to involve a
serious adverse drug experience or
serious product quality issue relating to
a drug product compounded at a
pharmacy and distributed outside the
State, the State BOP or other appropriate
State agency will share with FDA the
results of the investigation as permitted
by State law. The information will
include: (1) The State BOP or other
appropriate State agency’s assessment of
whether the complaint was
substantiated, if available and (2) a
description and date of any actions the
State BOP or other appropriate State
agency has taken to address the
complaint. In addition, the State BOP or
other appropriate State agency will
maintain records of the complaints they
receive, the investigation of each
complaint, and any response to or
action taken as a result of a complaint,
beginning when the State BOP or other
appropriate State agency receives notice
of the complaint. The State BOP or other
appropriate State agency will maintain
these records for at least 3 years,
beginning on the date of final action on
a complaint or the date of a decision
that the complaint requires no action.
The State BOP or other appropriate
State agency will notify the appropriate
regulator of physicians within the State
and will notify FDA by email at
StateMOU@fda.hhs.gov or by
submission to an information sharing
network as soon as possible, but no later
than 5 business days, after receiving any
complaint relating to a drug product
compounded by a physician and
distributed outside the State involving
an adverse drug experience or product
quality issue. The information will
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include, if available: (1) The name and
contact information of the complainant;
(2) the name and address of the
physician that is the subject of the
complaint; and (3) a description of the
complaint, including a description of
any compounded human drug product
that is the subject of the complaint.
In the Federal Register of September
10, 2018 (83 FR 45631), we published a
60-day notice requesting public
comment on the proposed collection of
information. We note that in the final
MOU we changed the title from
‘‘Memorandum of Understanding
Addressing Certain Distributions of
Compounded Drug Products Between
the State of [insert State] and the U.S.
Food and Drug Administration’’ to
‘‘Memorandum of Understanding
Addressing Certain Distributions of
Compounded Human Drug Products
Between the [insert State Board of
Pharmacy or other appropriate State
Agency] and the U.S. Food and Drug
Administration.’’ A number of
comments were received. Most
comments focused on State resource
issues including whether the extent,
nature, and frequency of information
collection and sharing was overly
burdensome and whether or not the
information collection imposed an
unfunded mandate on State agencies. In
consideration of the comments, FDA has
made the following changes to the
MOU:
• We have increased the time period,
from 3 days to 5 business days, to
communicate information about
complaints that involve serious adverse
drug experiences or serious product
quality issues relating to a human drug
product compounded at a pharmacy and
complaints that involve adverse drug
experiences or product quality issues
relating to a human drug product
compounded by a physician;
• we have increased the amount of
time after the final standard MOU is
available for signature from 180 days to
365 days before FDA intends to enforce
the 5 percent limit in States that have
not signed the final standard MOU; and
• we have coordinated with NABP to
develop an information-sharing network
to help reduce the information
collection and sharing burden on the
State BOPs or other appropriate State
agencies.
We disagree that the information
collections in the MOU create unfunded
mandates. Entering into the MOU is
voluntary. We believe the proposed
collection of information satisfies the
statutory objectives of providing FDA
with the information it needs through
the least burdensome means available.
None of the comments received
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provided alternative figures to the
burden estimates proffered, and we
therefore estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Compounding MOU between FDA and State BOPs or other appropriate State Agencies
Number of
responses
per
respondent
Number of
respondents
Total annual
responses
Average burden
per response
Total hours
State BOP or other appropriate State agency notifies FDA of compounding complaints
State BOP or other appropriate State agency identifies pharmacies that distribute inordinate amounts of compounded human drugs interstate using surveys or inspections or data submitted to an information sharing network.
State BOP or other appropriate State agency notifies FDA of the distribution of inordinate amounts of compounded human drug products.
State BOP or other appropriate State agency notifies FDA and appropriate State regulator of physicians about physicians who distribute compounded human drug products interstate.
State BOP or other appropriate State agency notifies FDA of a new liaison to the
MOU.
State BOP or other appropriate State agency notifies FDA of its intent to terminate
participation in the MOU.
45
45
3
145
135
6,525
0.5 (30 minutes)
1 .........................
45
44
1,980
0.5 (30 minutes)
990
45
5
225
0.5 (30 minutes)
112.5
13
1
13
0.2 (12 minutes)
2.6
1
1
1
0.2 (12 minutes)
0.2
Total ..........................................................................................................................
....................
....................
....................
1 There
67.5
6,525
.............................
7,697.8
Total annual
records
Average
burden per
recordkeeping
Total hours
90
1
90
are no capital costs or operating and mainenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Compounding MOU between FDA and State BOPs or other appropriate State Agencies
Number of
recordkeepers
State BOP or other appropriate State Agency Recordkeeping for 3 Years of
Compounding Complaints about Drug Products Compounded at a Pharmacy .......
45
1 There
Number of
records per
recordkeeper
2
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Compounding MOU between FDA and State BOP or other appropriate State Agencies
Number of
respondents
State BOP or other appropriate State agency notifies pharmacies that compound human
drugs, and the State authority that licenses or regulates physicians that its participation
in the MOU has terminated ...............................................................................................
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1 There
Number of
disclosures
per
respondent
1
Total annual
disclosures
1
1
Average
burden per
disclosure
1
Total hours
1
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on our knowledge of State
regulation of compounding practices
and related complaints, we estimate that
annually a total of approximately 45
State BOPs or other appropriate State
agencies (‘‘No. of Respondents’’ in table
1, row 2) will notify FDA within 5
business days of receiving any
complaint relating to a human drug
product compounded by a pharmacy
and distributed outside the State
involving a serious adverse drug
experience or serious product quality
issue or any complaint relating to a drug
product compounded by a physician
and distributed outside the State
involving any adverse drug experience
or product quality issue. We estimate
that each State BOP or other appropriate
State agency will notify FDA annually
of approximately 3 complaints it
receives (‘‘No. of Responses per
Respondent’’ in table 1, row 2), for a
total of 135 notifications of complaints
sent to FDA (‘‘Total Annual Responses’’
in table 1, row 2). We estimate that
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preparing and submitting this
information to FDA as described in the
MOU will take approximately 0.5 hours
per response (‘‘Average Burden per
Response’’ in table 1, row 1), for a total
of 67.5 hours (‘‘Total Hours’’ in table 1,
row 2).
We also estimate that a total of
approximately 45 State BOPs or other
appropriate State agencies (‘‘No. of
Recordkeepers’’ in table 2) will prepare
and maintain records for 3 years of the
complaints they receive, investigations
of complaints, and any State action
taken or response to complaints
involving drug products compounded at
a pharmacy and distributed outside the
State. We estimate that each State BOP
or other appropriate State agency will
receive annually approximately 2
complaints about adverse drug
experiences or product quality issues
relating to human drug products
compounded at a pharmacy and will
prepare and maintain approximately 1
record per each complaint the State BOP
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or other appropriate State agency
receives, for a total of 2 records per State
BOP or other appropriate State agency
(‘‘No. of Records per Recordkeeper’’ in
table 2), and a total of 90 records
annually across all States (‘‘Total
Annual Records’’ in table 2). We further
estimate that preparing and maintaining
these records will take approximately 1
hour per record (‘‘Average Burden per
Recordkeeping (in hours)’’ in table 2),
for a total of 90 hours (‘‘Total Hours’’ in
table 2).
Under section III.b of the final
standard MOU, on an annual basis, the
State BOP or other appropriate State
agency will identify, using surveys,
reviews of records during inspections,
data submitted to an information
sharing network, or other mechanisms
available to the State BOP or other
appropriate State agency, pharmacies
that distribute inordinate amounts of
compounded human drug products
interstate by collecting information
regarding the number of prescription
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orders for compounded human drug
products distributed interstate during
any calendar year and the number of
prescription orders for compounded
human drug products that the pharmacy
sent out of (or caused to be sent out of)
the facility in which the drug products
were compounded during that same
calendar year and the number of
prescription orders for compounded
human drug products that were
dispensed (e.g., picked up by a patient)
at the facility in which they are
compounded during that same calendar
year. If a pharmacy has been identified
as distributing inordinate amounts of
compounded human drug products
interstate, the State BOP or other
appropriate State agency will also
collect information regarding: (1) The
total number of prescription orders for
sterile compounded human drug
products distributed interstate; (2) the
names of States in which the pharmacy
is licensed; (3) the names of States into
which the pharmacy distributed
compounded human drug products; and
(4) whether the State inspected for and
found during its most recent inspection
that the pharmacy distributed
compounded human drug products
without valid prescription orders for
individually identified patients.
The State BOP or other appropriate
State agency will notify FDA by
submission to an information sharing
network or by sending an email to
StateMOU@fda.hhs.gov within 30
business days of identifying a pharmacy
that has distributed inordinate amounts
of compounded human drug products
interstate, as described in the final
standard MOU. The notification will
include the name and address of the
pharmacy and the information that the
State BOP or other appropriate State
agency collected, described in the
previous paragraph.
The State BOP or other appropriate
State agency will notify the appropriate
regulator of physicians within the State
and FDA by submission to an
information sharing network or by
sending an email to StateMOU@
fda.hhs.gov within 30 business days of
identifying a physician that has
distributed compounded human drug
products interstate.
We estimate that annually a total of
approximately 45 State BOPs or other
appropriate State agencies (‘‘No. of
Respondents’’ in table 1, row 3) will
identify pharmacies that distribute
inordinate amounts of compounded
human drug products interstate. We
estimate that each State agency will
perform surveys or inspections of 145
pharmacies or use the information
sharing network to identify this
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information (‘‘No. of Responses per
Respondent’’ in table 1, row 3). We
estimate that this will take
approximately 1 hour per response
(‘‘average burden per response’’ in table
1, row 3), for a total of 6,525 hours
(‘‘Total Hours’’ in table 1, row 3). We
estimate that annually a total of 45 State
BOPs or other appropriate State
agencies (‘‘No. of Respondents’’ in table
1, row 4) will find that a pharmacy has
distributed inordinate amounts of
compounded human drug products
interstate and notify FDA of this
finding. We estimate that each State
BOP or other appropriate State agency
will notify FDA annually of
approximately 44 findings it makes
(‘‘No. of Responses per Respondent’’ in
table 1, row 4), for a total of 1,980
notifications (‘‘Total Annual Responses’’
in table 1, row 4). We estimate that
preparing and submitting this
information to FDA as described in the
MOU will take approximately 0.5 hours
per response (‘‘Average Burden per
Response’’ in table 1, row 4), for a total
of 990 hours (‘‘Total Hours’’ in table 1,
row 4).
We estimate that annually a total of
approximately 45 State BOPs or other
appropriate State agencies (‘‘No. of
Respondents’’ in table 1, row 5) will
become aware of physicians that
distribute compounded human drug
products interstate. We estimate that
each State BOP or other appropriate
State agency will notify the appropriate
regulator of physicians within the State
and FDA annually of approximately five
physicians that distribute compounded
human drug products interstate (‘‘No. of
Responses per Respondent’’ in table 1,
row 5), for a total of 225 notifications of
physicians that distribute compounded
human drug products interstate sent to
FDA (‘‘Total Annual Responses’’ in
table 1, row 5). We estimate that
preparing and submitting this
information to us as described in the
MOU will take approximately 0.5 hours
per response (‘‘Average Burden per
Response’’ in table 1, row 1), for a total
of 112.5 hours (‘‘Total Hours’’ in table
1, row 5).
Under section V of the final standard
MOU, a State BOP or other appropriate
State agency may designate a new
liaison to the MOU by notifying FDA’s
liaison in writing. If a State BOP or
other appropriate State agency’s liaison
becomes unavailable to fulfill its
functions under the MOU, the State
BOP or other appropriate State agency
will name a new liaison within 2 weeks
and notify FDA.
We estimate that annually a total of
approximately 13 State BOPs or other
appropriate State agencies (‘‘No. of
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Respondents’’ in table 1, row 5) will
notify FDA of a new liaison to the MOU.
We estimate that each State BOP or
other appropriate State will submit to
FDA annually approximately 1
notification of a new liaison (‘‘No. of
Responses per Respondent’’ in table 1,
row 6), for a total of 13 notifications of
a new liaison (‘‘Total Annual
Responses’’ in table 1, row 6). We
estimate that preparing and submitting
each notification as described in the
MOU will take approximately 0.2 hours
per response (‘‘Average Burden per
Response’’ in table 1, row 6), for a total
of 2.6 hours (‘‘Total Hours’’ in table 1,
row 6).
Under section VI of the revised final
standard MOU, a State BOP or other
appropriate State agency may terminate
its participation in the MOU by
submitting to FDA a 60 calendar day
notice of termination.
We estimate that annually a total of
approximately one State BOP or other
appropriate State agency (‘‘No. of
Respondents’’ in table 1, row 7) will
notify FDA that it intends to terminate
its participation in the MOU. We
estimate that this State BOP or other
appropriate State agency will submit to
FDA annually approximately one
notification of termination (‘‘No. of
Responses per Respondent’’ in table 1,
row 7), for a total of one notification
(‘‘Total Annual Responses’’ in table 1,
row 7). We estimate that preparing and
submitting the notification as described
in the MOU will take approximately 0.2
hours per notification (‘‘Average Burden
per Response’’ in table 1, row 7), for a
total of 0.2 hours (‘‘Total Hours’’ in table
1, row 7).
We estimate that annually a total of
approximately one State BOP or other
appropriate State agency (‘‘No. of
Respondents’’ in table 3, row 2) will
notify pharmacists and the State
authority that licenses or regulates
physicians that its participation in the
MOU has terminated. We estimate that
this State BOP or other appropriate State
agency will distribute approximately
one notification of termination (‘‘No. of
Responses per Respondent’’ in table 1,
row 7), for a total of one notification
(‘‘Total Annual Responses’’ in table 3,
row 2).
We estimate that preparing and
submitting the notification as described
in the MOU will take approximately 1
hour per notification (‘‘Average Burden
per Response’’ in table 3, row 2), for a
total of 1 hour (‘‘Total Hours’’ in table
3, row 2).
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Dated: May 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–10336 Filed 5–13–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Advisory Committee on
Children and Disasters: Establishment
Office of the Assistant
Secretary for Preparedness and
Response (ASPR), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Office of the Assistant
Secretary for Preparedness and
Response (ASPR), in the Department of
Health and Human Services (HHS)
Office of the Secretary announces
establishment of the National Advisory
Committee on Children and Disasters
(NACCD). The Advisory Committee will
provide advice and consultation to the
HHS Secretary on pediatric medical
disaster planning, preparedness,
response, and recovery with respect to
the medical and public health needs of
children in relation to disasters. The
Office of the Assistant Secretary for
Preparedness and Response (ASPR)
shall provide management and
administrative oversight to support the
activities of the Advisory Committee.
The Office of the Secretary is accepting
application submissions from qualified
individuals who wish to be considered
for membership on the NACCD. Up to
13 new voting members with expertise
in pediatric medical disaster planning,
preparedness, response, or recovery will
be selected for the Committee. Please
visit the NACCD website at
www.phe.gov/naccd for all application
submission information and
instructions. Application submissions
will be accepted for 30 calendar days
from the date this posting is published
in the Federal Register.
Application Period: The application
period is from midnight (Eastern Time)
May 27th–June 27th.
FOR FURTHER INFORMATION CONTACT:
Maxine Kellman, DVM, Ph.D., PMP,
Alternate Designated Federal Official for
National Advisory Committees,
Washington, DC, Office (202) 260–0447
or email maxine.kellman@hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to the Federal Advisory Committee Act
(FACA) of 1972, the HHS Secretary, in
consultation with the Secretary of the
U.S. Department of Homeland Security,
established the National Advisory
Committee on Children and Disasters
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:29 May 13, 2020
Jkt 250001
(NACCD). Section 2811A of the Public
Health Service Act, as amended by
Pandemic and All Hazard Preparedness
and Advancing Innovation Act of 2019
(42 U.S.C. 300hh–10b) requires that the
Secretary for Health and Human
Services (HHS) establish the National
Advisory Committee on Children and
Disasters (NACCD) to provide advice
and consultation to the HHS Secretary
with respect to the medical and public
health needs of children in relation to
disasters. The purpose of the NACCD is
to provide advice and consultation to
the HHS Secretary with respect to the
medical and public health needs of
children in relation to disasters. The
Office of the Assistant Secretary for
Preparedness and Response provides
management and administrative
oversight to support the activities of the
NACCD.
Description of Duties: The NACCD: (1)
Provides advice and consultation with
respect to the activities addressing atrisk individuals carried out as
applicable and appropriate (2) evaluates
and provides input with respect to the
medical and public health needs of
children as they relate to preparation
for, response to, and recovery from allhazards emergencies; (3) provides
advice and consultation with respect to
state emergency preparedness and
response activities and children,
including related drills and exercises
pursuant to the preparedness goals
under the National Health Security
Strategy; and (4) provides advice and
recommendations to the HHS Secretary
with respect to children and the medical
and public health grants and
cooperative agreements implementing
the Public Health Emergency
Preparedness and Hospital Preparedness
Programs and other activities, as
applicable to preparedness and response
activities.
Structure: The Advisory Committee
consists of not more than 13 voting
members, including the Chairperson.
Members will be appointed by the HHS
Secretary, in consultation with such
other Secretaries as may be appropriate,
from among the nation’s preeminent
scientific, public health, and medical
experts in areas consistent with the
purpose and functions of the NACCD.
Section 2811A(d)(2) of the Public Health
Services (PHS) Act States:
(2) REQUIRED NON–FEDERAL
MEMBERS.—The Secretary, in
consultation with such other heads of
Federal agencies as may be appropriate,
shall appoint to the Advisory
Committee under paragraph (1) at least
13 individuals, including—
(A) at least 2 non-Federal
professionals with expertise in pediatric
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
28965
medical disaster planning,
preparedness, response, or recovery;
(B) at least 2 representatives from
State, local, Tribal, or territorial
agencies with expertise in pediatric
disaster planning, preparedness,
response, or recovery;
(C) at least 4 members representing
health care professionals, which may
include members with expertise in
pediatric emergency medicine; pediatric
trauma, critical care, or surgery; the
treatment of pediatric patients affected
by chemical, biological, radiological, or
nuclear agents, including emerging
infectious diseases; pediatric mental or
behavioral health related to children
affected by a public health emergency;
or pediatric primary care; and
(D) other members as the Secretary
determines appropriate, of whom—
(i) at least one such member shall
represent a children’s hospital;
(ii) at least one such member shall be
an individual with expertise in schools
or child care settings;
(iii) at least one such member shall be
an individual with expertise in children
and youth with special health care
needs; and
(iv) at least one such member shall be
an individual with expertise in the
needs of parents or family caregivers,
including the parents or caregivers of
children with disabilities in the
following categories: Non-federal health
care professionals and representatives
from state, local, territorial, or tribal
agencies.
The NACCD shall also have up to 12
federal, non-voting members (ex officio),
including the following officials or their
designees:
A. The Assistant Secretary for
Preparedness and Response;
B. The Director of the Biomedical
Advanced Research and Development
Authority;
C. The Director of the Centers for
Disease Control and Prevention;
D. The Commissioner of Food and
Drugs;
E. The Director of the National
Institutes of Health;
F. The Assistant Secretary of the
Administration for Children and
Families;
G. The Administrator of the Health
Resources and Services Administration;
H. The Administrator of the Federal
Emergency Management Agency;
I. The Administrator of the
Administration for Community Living;
J. The Secretary of Education;
K. The Assistant Secretary for Mental
Health and Substance Use; and
L. The Administrator of the
Environmental Protection Agency.
A voting member of the NACCD shall
serve for a term of three years, except
E:\FR\FM\14MYN1.SGM
14MYN1
]]>Agencies
[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Notices]
[Pages 28961-28965]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10336]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3065]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Human Drug
Compounding Under Sections 503A and 503B of the Federal Food, Drug, and
Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) 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: Submit written comments (including recommendations) on the
collection of information by June 15, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0800. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: 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,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Human Drug Compounding Under Sections 503A and 503B of the Federal
Food, Drug, and Cosmetic Act
OMB Control Number 0910-0800--Revision
This information collection supports Agency implementation of
sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
(FD&C Act). For efficiency of Agency operations, we are revising the
information collection currently approved under OMB control number
0910-0800 pertaining to human drug compounding and section 503B of the
FD&C Act (21 U.S.C. 355b) to include reference to Agency guidance
regarding section 503A of the FD&C Act (21 U.S.C. 355a), and to also
include information collection that we attribute to a final standard
memorandum of understanding (MOU) provided for by section 503A (``final
standard MOU''). Finally, we are revising the title of the information
collection from ``Adverse Event Reporting for Outsourcing Facilities
Under Section 503B of the Federal Food, Drug, and Cosmetic Act'' to
``Human Drug Compounding Under Sections 503A and 503B of the Federal
Food, Drug, and Cosmetic Act.'' As information collection activity is
planned and undertaken by FDA, we find consolidating related collection
elements better utilizes our resources.
Agency Guidance Regarding Section 503A
We are revising the information collection to include reference to
the guidance entitled ``Pharmacy Compounding of Human Drug Products
Under Section 503A of the Federal Food, Drug, and Cosmetic Act.'' The
guidance is available from our website at: https://www.fda.gov/media/94393/download. The guidance was issued consistent with our Good
Guidance Practice regulations (21 CFR 10.115), which provide for
comment at any time. The guidance communicates FDA's intention with
regard to enforcement of section 503A of the FD&C Act to regulate
entities that compound drugs and notes that parts of section 503A
require rulemaking and consultation with a Pharmacy Compounding
Advisory Committee to implement and explains how the provisions will be
applied pending those consultations and rulemaking. Although the
guidance does not include recommended information collection, we are
including the guidance as a supplemental reference for respondents.
[[Page 28962]]
The Final Standard MOU
We are also revising the information collection to include
information collection associated with the standard MOU pursuant to the
provisions of the Food and Drug Administration Modernization Act of
1997 (FDAMA) (Pub. L. 105-115) found in section 503A of the FD&C Act.
Section 503A of the FD&C Act describes the conditions under which
certain drug products compounded by a licensed pharmacist in a State-
licensed pharmacy or Federal facility, or by a licensed physician are
exempt from certain sections of the FD&C Act. One of the conditions to
qualify for the exemptions listed in section 503A of the FD&C Act is
that: (1) The drug product is compounded in a State that has entered
into an MOU with FDA that addresses the distribution of inordinate
amounts of compounded drug products interstate and provides for
appropriate investigation by a State agency of complaints relating to
compounded drug products distributed outside such a State or (2) if the
drug product is compounded in a State that has not entered into such an
MOU, the licensed pharmacist, licensed pharmacy, or licensed physician
does not distribute, or cause to be distributed, compounded drug
products out of the State in which they are compounded, in quantities
that exceed 5 percent of the total prescription orders dispensed or
distributed by such pharmacy or physician (see section 503A(b)(3)(B) of
the FD&C Act).
Section 503A(b)(3)(B) of the FD&C Act directs FDA, in consultation
with the National Association of Boards of Pharmacy (NABP), to develop
a standard MOU for use by States in complying with the provision that
references an MOU that addresses the distribution of inordinate amounts
of compounded drug products interstate and provides for appropriate
investigation by a State agency of complaints relating to drug products
compounded in the State and distributed outside such State.
Accordingly, we have developed the document entitled, ``Memorandum of
Understanding Addressing Certain Distributions of Compounded Human Drug
Products Between the [Insert State Board of Pharmacy or Other
Appropriate State Agency] and the U.S. Food and Drug Administration,''
available in docket number FDA-2018-N-3065, which is available at:
https://www.regulations.gov/docket?D=FDA-2018-N-3065.
For purposes of this analysis, FDA assumes that 45 States will sign
the standard MOU with FDA.
Under section III.a of the final standard MOU, the State Board of
Pharmacy (BOP) or other appropriate State agency will notify FDA by
submission to an information sharing network or by sending an email to
[email protected] as soon as possible, but no later than 5 business
days, after receiving a complaint relating to a human drug product
compounded at a pharmacy and distributed outside the State involving a
serious adverse drug experience or serious product quality issue. The
notification will include the following information: (1) The name and
contact information of the complainant, if available; (2) the name and
address of the pharmacy that is the subject of the complaint; and (3) a
description of the complaint, including a description of any compounded
human drug product that is the subject of the complaint. After the
State BOP or other appropriate State agency concludes its investigation
of a complaint assessed to involve a serious adverse drug experience or
serious product quality issue relating to a drug product compounded at
a pharmacy and distributed outside the State, the State BOP or other
appropriate State agency will share with FDA the results of the
investigation as permitted by State law. The information will include:
(1) The State BOP or other appropriate State agency's assessment of
whether the complaint was substantiated, if available and (2) a
description and date of any actions the State BOP or other appropriate
State agency has taken to address the complaint. In addition, the State
BOP or other appropriate State agency will maintain records of the
complaints they receive, the investigation of each complaint, and any
response to or action taken as a result of a complaint, beginning when
the State BOP or other appropriate State agency receives notice of the
complaint. The State BOP or other appropriate State agency will
maintain these records for at least 3 years, beginning on the date of
final action on a complaint or the date of a decision that the
complaint requires no action.
The State BOP or other appropriate State agency will notify the
appropriate regulator of physicians within the State and will notify
FDA by email at [email protected] or by submission to an information
sharing network as soon as possible, but no later than 5 business days,
after receiving any complaint relating to a drug product compounded by
a physician and distributed outside the State involving an adverse drug
experience or product quality issue. The information will include, if
available: (1) The name and contact information of the complainant; (2)
the name and address of the physician that is the subject of the
complaint; and (3) a description of the complaint, including a
description of any compounded human drug product that is the subject of
the complaint.
In the Federal Register of September 10, 2018 (83 FR 45631), we
published a 60-day notice requesting public comment on the proposed
collection of information. We note that in the final MOU we changed the
title from ``Memorandum of Understanding Addressing Certain
Distributions of Compounded Drug Products Between the State of [insert
State] and the U.S. Food and Drug Administration'' to ``Memorandum of
Understanding Addressing Certain Distributions of Compounded Human Drug
Products Between the [insert State Board of Pharmacy or other
appropriate State Agency] and the U.S. Food and Drug Administration.''
A number of comments were received. Most comments focused on State
resource issues including whether the extent, nature, and frequency of
information collection and sharing was overly burdensome and whether or
not the information collection imposed an unfunded mandate on State
agencies. In consideration of the comments, FDA has made the following
changes to the MOU:
We have increased the time period, from 3 days to 5
business days, to communicate information about complaints that involve
serious adverse drug experiences or serious product quality issues
relating to a human drug product compounded at a pharmacy and
complaints that involve adverse drug experiences or product quality
issues relating to a human drug product compounded by a physician;
we have increased the amount of time after the final
standard MOU is available for signature from 180 days to 365 days
before FDA intends to enforce the 5 percent limit in States that have
not signed the final standard MOU; and
we have coordinated with NABP to develop an information-
sharing network to help reduce the information collection and sharing
burden on the State BOPs or other appropriate State agencies.
We disagree that the information collections in the MOU create
unfunded mandates. Entering into the MOU is voluntary. We believe the
proposed collection of information satisfies the statutory objectives
of providing FDA with the information it needs through the least
burdensome means available. None of the comments received
[[Page 28963]]
provided alternative figures to the burden estimates proffered, and we
therefore estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Compounding MOU between FDA and Number of responses Total Average burden per
State BOPs or other appropriate respondents per annual response Total hours
State Agencies respondent responses
----------------------------------------------------------------------------------------------------------------
State BOP or other appropriate 45 3 135 0.5 (30 minutes)........ 67.5
State agency notifies FDA of
compounding complaints.
State BOP or other appropriate 45 145 6,525 1....................... 6,525
State agency identifies
pharmacies that distribute
inordinate amounts of compounded
human drugs interstate using
surveys or inspections or data
submitted to an information
sharing network.
State BOP or other appropriate 45 44 1,980 0.5 (30 minutes)........ 990
State agency notifies FDA of the
distribution of inordinate
amounts of compounded human drug
products.
State BOP or other appropriate 45 5 225 0.5 (30 minutes)........ 112.5
State agency notifies FDA and
appropriate State regulator of
physicians about physicians who
distribute compounded human drug
products interstate.
State BOP or other appropriate 13 1 13 0.2 (12 minutes)........ 2.6
State agency notifies FDA of a
new liaison to the MOU.
State BOP or other appropriate 1 1 1 0.2 (12 minutes)........ 0.2
State agency notifies FDA of its
intent to terminate participation
in the MOU.
-----------------------------------------------------------------------------
Total......................... ........... ........... ........... ........................ 7,697.8
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and mainenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Compounding MOU between FDA and State Number of Total Average burden
BOPs or other appropriate State Number of records per annual per Total hours
Agencies recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
State BOP or other appropriate State 45 2 90 1 90
Agency Recordkeeping for 3 Years of
Compounding Complaints about Drug
Products Compounded at a Pharmacy....
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Total Average
Compounding MOU between FDA and State BOP or Number of disclosures annual burden per Total hours
other appropriate State Agencies respondents per respondent disclosures disclosure
----------------------------------------------------------------------------------------------------------------
State BOP or other appropriate State agency 1 1 1 1 1
notifies pharmacies that compound human
drugs, and the State authority that
licenses or regulates physicians that its
participation in the MOU has terminated....
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on our knowledge of State regulation of compounding practices
and related complaints, we estimate that annually a total of
approximately 45 State BOPs or other appropriate State agencies (``No.
of Respondents'' in table 1, row 2) will notify FDA within 5 business
days of receiving any complaint relating to a human drug product
compounded by a pharmacy and distributed outside the State involving a
serious adverse drug experience or serious product quality issue or any
complaint relating to a drug product compounded by a physician and
distributed outside the State involving any adverse drug experience or
product quality issue. We estimate that each State BOP or other
appropriate State agency will notify FDA annually of approximately 3
complaints it receives (``No. of Responses per Respondent'' in table 1,
row 2), for a total of 135 notifications of complaints sent to FDA
(``Total Annual Responses'' in table 1, row 2). We estimate that
preparing and submitting this information to FDA as described in the
MOU will take approximately 0.5 hours per response (``Average Burden
per Response'' in table 1, row 1), for a total of 67.5 hours (``Total
Hours'' in table 1, row 2).
We also estimate that a total of approximately 45 State BOPs or
other appropriate State agencies (``No. of Recordkeepers'' in table 2)
will prepare and maintain records for 3 years of the complaints they
receive, investigations of complaints, and any State action taken or
response to complaints involving drug products compounded at a pharmacy
and distributed outside the State. We estimate that each State BOP or
other appropriate State agency will receive annually approximately 2
complaints about adverse drug experiences or product quality issues
relating to human drug products compounded at a pharmacy and will
prepare and maintain approximately 1 record per each complaint the
State BOP or other appropriate State agency receives, for a total of 2
records per State BOP or other appropriate State agency (``No. of
Records per Recordkeeper'' in table 2), and a total of 90 records
annually across all States (``Total Annual Records'' in table 2). We
further estimate that preparing and maintaining these records will take
approximately 1 hour per record (``Average Burden per Recordkeeping (in
hours)'' in table 2), for a total of 90 hours (``Total Hours'' in table
2).
Under section III.b of the final standard MOU, on an annual basis,
the State BOP or other appropriate State agency will identify, using
surveys, reviews of records during inspections, data submitted to an
information sharing network, or other mechanisms available to the State
BOP or other appropriate State agency, pharmacies that distribute
inordinate amounts of compounded human drug products interstate by
collecting information regarding the number of prescription
[[Page 28964]]
orders for compounded human drug products distributed interstate during
any calendar year and the number of prescription orders for compounded
human drug products that the pharmacy sent out of (or caused to be sent
out of) the facility in which the drug products were compounded during
that same calendar year and the number of prescription orders for
compounded human drug products that were dispensed (e.g., picked up by
a patient) at the facility in which they are compounded during that
same calendar year. If a pharmacy has been identified as distributing
inordinate amounts of compounded human drug products interstate, the
State BOP or other appropriate State agency will also collect
information regarding: (1) The total number of prescription orders for
sterile compounded human drug products distributed interstate; (2) the
names of States in which the pharmacy is licensed; (3) the names of
States into which the pharmacy distributed compounded human drug
products; and (4) whether the State inspected for and found during its
most recent inspection that the pharmacy distributed compounded human
drug products without valid prescription orders for individually
identified patients.
The State BOP or other appropriate State agency will notify FDA by
submission to an information sharing network or by sending an email to
[email protected] within 30 business days of identifying a pharmacy
that has distributed inordinate amounts of compounded human drug
products interstate, as described in the final standard MOU. The
notification will include the name and address of the pharmacy and the
information that the State BOP or other appropriate State agency
collected, described in the previous paragraph.
The State BOP or other appropriate State agency will notify the
appropriate regulator of physicians within the State and FDA by
submission to an information sharing network or by sending an email to
[email protected] within 30 business days of identifying a physician
that has distributed compounded human drug products interstate.
We estimate that annually a total of approximately 45 State BOPs or
other appropriate State agencies (``No. of Respondents'' in table 1,
row 3) will identify pharmacies that distribute inordinate amounts of
compounded human drug products interstate. We estimate that each State
agency will perform surveys or inspections of 145 pharmacies or use the
information sharing network to identify this information (``No. of
Responses per Respondent'' in table 1, row 3). We estimate that this
will take approximately 1 hour per response (``average burden per
response'' in table 1, row 3), for a total of 6,525 hours (``Total
Hours'' in table 1, row 3). We estimate that annually a total of 45
State BOPs or other appropriate State agencies (``No. of Respondents''
in table 1, row 4) will find that a pharmacy has distributed inordinate
amounts of compounded human drug products interstate and notify FDA of
this finding. We estimate that each State BOP or other appropriate
State agency will notify FDA annually of approximately 44 findings it
makes (``No. of Responses per Respondent'' in table 1, row 4), for a
total of 1,980 notifications (``Total Annual Responses'' in table 1,
row 4). We estimate that preparing and submitting this information to
FDA as described in the MOU will take approximately 0.5 hours per
response (``Average Burden per Response'' in table 1, row 4), for a
total of 990 hours (``Total Hours'' in table 1, row 4).
We estimate that annually a total of approximately 45 State BOPs or
other appropriate State agencies (``No. of Respondents'' in table 1,
row 5) will become aware of physicians that distribute compounded human
drug products interstate. We estimate that each State BOP or other
appropriate State agency will notify the appropriate regulator of
physicians within the State and FDA annually of approximately five
physicians that distribute compounded human drug products interstate
(``No. of Responses per Respondent'' in table 1, row 5), for a total of
225 notifications of physicians that distribute compounded human drug
products interstate sent to FDA (``Total Annual Responses'' in table 1,
row 5). We estimate that preparing and submitting this information to
us as described in the MOU will take approximately 0.5 hours per
response (``Average Burden per Response'' in table 1, row 1), for a
total of 112.5 hours (``Total Hours'' in table 1, row 5).
Under section V of the final standard MOU, a State BOP or other
appropriate State agency may designate a new liaison to the MOU by
notifying FDA's liaison in writing. If a State BOP or other appropriate
State agency's liaison becomes unavailable to fulfill its functions
under the MOU, the State BOP or other appropriate State agency will
name a new liaison within 2 weeks and notify FDA.
We estimate that annually a total of approximately 13 State BOPs or
other appropriate State agencies (``No. of Respondents'' in table 1,
row 5) will notify FDA of a new liaison to the MOU. We estimate that
each State BOP or other appropriate State will submit to FDA annually
approximately 1 notification of a new liaison (``No. of Responses per
Respondent'' in table 1, row 6), for a total of 13 notifications of a
new liaison (``Total Annual Responses'' in table 1, row 6). We estimate
that preparing and submitting each notification as described in the MOU
will take approximately 0.2 hours per response (``Average Burden per
Response'' in table 1, row 6), for a total of 2.6 hours (``Total
Hours'' in table 1, row 6).
Under section VI of the revised final standard MOU, a State BOP or
other appropriate State agency may terminate its participation in the
MOU by submitting to FDA a 60 calendar day notice of termination.
We estimate that annually a total of approximately one State BOP or
other appropriate State agency (``No. of Respondents'' in table 1, row
7) will notify FDA that it intends to terminate its participation in
the MOU. We estimate that this State BOP or other appropriate State
agency will submit to FDA annually approximately one notification of
termination (``No. of Responses per Respondent'' in table 1, row 7),
for a total of one notification (``Total Annual Responses'' in table 1,
row 7). We estimate that preparing and submitting the notification as
described in the MOU will take approximately 0.2 hours per notification
(``Average Burden per Response'' in table 1, row 7), for a total of 0.2
hours (``Total Hours'' in table 1, row 7).
We estimate that annually a total of approximately one State BOP or
other appropriate State agency (``No. of Respondents'' in table 3, row
2) will notify pharmacists and the State authority that licenses or
regulates physicians that its participation in the MOU has terminated.
We estimate that this State BOP or other appropriate State agency will
distribute approximately one notification of termination (``No. of
Responses per Respondent'' in table 1, row 7), for a total of one
notification (``Total Annual Responses'' in table 3, row 2).
We estimate that preparing and submitting the notification as
described in the MOU will take approximately 1 hour per notification
(``Average Burden per Response'' in table 3, row 2), for a total of 1
hour (``Total Hours'' in table 3, row 2).
[[Page 28965]]
Dated: May 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10336 Filed 5-13-20; 8:45 am]
BILLING CODE 4164-01-P
