Agency Information Collection Activities; Proposed Collection; Comment Request; Medication Guides for Prescription Drug Products, 16199-16201 [2022-06034]
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Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices
• Audere’s HealthPulse@home,
issued November 30, 2021; 9
In addition, on September 23, 2021,
FDA issued a letter to Developers of
Certain Molecular, Antigen and
Serology In Vitro Diagnostics (IVDs)
Authorized for Emergency Use for
Coronavirus Disease 2019 (COVID–19)
as of Today’s Date (September 23, 2021)
for Establishing additional Conditions of
Authorization for the EUAs of Certain
Molecular, Antigen and Serology IVDs
related to viral mutations.10
Dated: March 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–06008 Filed 3–21–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0902]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medication Guides
for Prescription Drug Products
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
transport human specimens so that an authorized
laboratory can detect SARS–CoV–2 RNA from the
collected human specimen, and that the known and
potential benefits of the product when used for
such use, outweigh the known and potential risks
of the product; and (3) there is no adequate,
approved, and available alternative to the
emergency use of the product.
9 As set forth in the EUA, FDA has concluded
that: (1) SARS–CoV–2 can cause a serious or lifethreatening disease or condition, including severe
respiratory illness, to humans infected by this virus;
(2) based on the totality of scientific evidence
available to FDA, it is reasonable to believe that the
product may be effective in diagnosing COVID–19
by serving as an appropriate means to collect and
transport human specimens so that an authorized
laboratory can detect SARS–CoV–2 RNA from the
collected human specimen, and that the known and
potential benefits of the product when used for
such use, outweigh the known and potential risks
of the product; and (3) there is no adequate,
approved, and available alternative to the
emergency use of the product.
10 FDA concluded that establishing additional
conditions on the EUAs within the scope of the
letter is appropriate to protect the public health or
safety and revised all such EUAs pursuant to
Section 564(g)(2)(C) of the FD&C Act to establish
the three additional conditions set forth in the letter
as permitted by Section 564(e) of the FD&C Act.
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1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed revision of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on information
collection associated with Medication
Guides for prescription drug products.
DATES: Submit either electronic or
written comments on the collection of
information by May 23, 2022.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
May 23, 2022. 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.
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.
PO 00000
Frm 00038
Fmt 4703
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16199
• 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 Docket No. FDA–2011–N–
0902 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Medication Guide Requirements for
Prescription Drug Product Labeling.’’
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, 240–402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/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
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Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
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.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2(A) of the PRA (44
U.S.C. 3506(c)(2)(A) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed revision of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Medication Guide Requirements for
Prescription Drug Product Labeling
OMB Control Number 0910–0393—
Extension
This information collection supports
FDA regulations pertaining to the
distribution of patient labeling, called
Medication Guides, for human
prescription drug and biological
products used primarily on an
outpatient basis, and required for
products that pose a serious and
significant public health concern.
Applicable regulations are codified at 21
CFR part 208: Medication Guides for
Prescription Drug Products, and set
forth general content and format
requirements, as well as provide for
exemptions and deferrals. Medication
Guides provide patients with important
written information about drug
products, including the drug’s approved
uses, contraindications, adverse drug
reactions, and cautions for specific
populations, and are required in
accordance with Agency regulations.
To assist consumers and industry
with understanding applicable
regulatory requirements in 21 CFR part
208 pertaining to developing,
distributing, and submitting certain
Medication Guides, we have developed
the guidance document entitled
‘‘Medication Guides—Distribution
Requirements and Inclusion in Risk
Evaluation and Mitigation Strategies
(REMS)’’ (available at https://
www.fda.gov/media/79776/download).
The guidance document includes a
discussion of the applicable regulations;
FDA enforcement policy with regard to
Medication Guides associated with
products dispensed to healthcare
professionals, or patient caregivers,
instead of being dispensed directly to
the patient for self-administration; and
Medication Guides required as part of a
risk evaluation and mitigation strategy.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity; 21 CFR section
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Content and format of a Medication Guide; § 208.20 .........
Exemptions and deferrals; § 208.26(a) ................................
41
1
1
1
41
1
320
4
13,120
4
Total ..............................................................................
........................
........................
42
........................
13,124
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Upon evaluation of the information
collection, we have removed burden we
attributed to reporting associated with
supplements and other changes to
approved abbreviated new drug
applications, new drug applications,
and biologics license applications (21
CFR 314.70(b)(3)(ii) and 601.12(f)). We
now account for burden associated with
these regulatory provisions in OMB
control numbers 0910–0001 and 0910–
0338 and have decreased the burden
associated with this collection
accordingly.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
lotter on DSK11XQN23PROD with NOTICES1
Activity; 21 CFR section
Distribute Medication Guides to authorized dispensers; § 208.24(c).
Distribute and Dispense Medication Guides to Patients; § 208.24(e).
Total ....................................................................
1 There
Number of
disclosures per
respondent
Total annual
disclosures
Average burden
per disclosure 2
191
9,000
1,719,000
1.25 .......................
2,148,750
88,000
5,705
502,040,000
0.05 (3 minutes) ....
25,102,000
........................
..........................
503,759,000
...............................
27,250,750
are no capital costs or operating and maintenance costs associated with this collection of information.
may not sum due to rounding.
2 Numbers
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Total hours
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Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices
We have decreased our estimated
burden associated with disclosures to
reflect a decrease in related submissions
over the past 3 years.
Dated: March 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
0002. Send one self-addressed adhesive
label to assist that office in processing
your request or include a Fax number to
which the Authorization may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorization.
[FR Doc. 2022–06034 Filed 3–21–22; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4164–01–P
Michael Mair, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4340, Silver Spring, MD 20993–0002,
301–796–8510 (this is not a toll free
number).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0335]
SUPPLEMENTARY INFORMATION:
Authorization of Emergency Use of a
Biological Product During the COVID–
19 Pandemic; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of an Emergency Use
Authorization (EUA) (the Authorization)
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) for use during
the COVID–19 pandemic. FDA has
issued one Authorization for a
biological product as requested by Eli
Lilly and Company (Lilly). The
Authorization contains, among other
things, conditions on the emergency use
of the authorized product. The
Authorization follows the February 4,
2020, determination by the Secretary of
Health and Human Services (HHS) that
there is a public health emergency that
has a significant potential to affect
national security or the health and
security of U.S. citizens living abroad
and that involves a novel (new)
coronavirus. The virus, now named
SARS–CoV–2, causes the illness
COVID–19. On the basis of such
determination, the Secretary of HHS
declared on March 27, 2020, that
circumstances exist justifying the
authorization of emergency use of drugs
and biological products during the
COVID–19 pandemic, pursuant to the
FD&C Act, subject to the terms of any
authorization issued under that section.
The Authorization, which includes an
explanation of the reasons for issuance,
is reprinted in this document.
DATES: The Authorization is effective as
of February 11, 2022.
ADDRESSES: Submit written requests for
a single copy of the EUA to the Office
of Counterterrorism and Emerging
Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1,
Rm. 4338, Silver Spring, MD 20993–
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:24 Mar 21, 2022
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I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) allows FDA to
strengthen public health protections
against biological, chemical, nuclear,
and radiological agents. Among other
things, section 564 of the FD&C Act
allows FDA to authorize the use of an
unapproved medical product or an
unapproved use of an approved medical
product in certain situations. With this
EUA authority, FDA can help ensure
that medical countermeasures may be
used in emergencies to diagnose, treat,
or prevent serious or life-threatening
diseases or conditions caused by
biological, chemical, nuclear, or
radiological agents when there are no
adequate, approved, and available
alternatives (among other criteria).
II. Criteria for EUA Authorization
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (1) A
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a biological, chemical, radiological,
or nuclear agent or agents; (2) a
determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to U.S. military forces,
including personnel operating under the
authority of title 10 or title 50, U.S.
Code, of attack with (A) a biological,
chemical, radiological, or nuclear agent
or agents; or (B) an agent or agents that
may cause, or are otherwise associated
with, an imminently life-threatening
and specific risk to U.S. military
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
16201
forces; 1 (3) a determination by the
Secretary of HHS that there is a public
health emergency, or a significant
potential for a public health emergency,
that affects, or has a significant potential
to affect, national security or the health
and security of U.S. citizens living
abroad, and that involves a biological,
chemical, radiological, or nuclear agent
or agents, or a disease or condition that
may be attributable to such agent or
agents; or (4) the identification of a
material threat by the Secretary of
Homeland Security pursuant to section
319F–2 of the Public Health Service
(PHS) Act (42 U.S.C. 247d–6b) sufficient
to affect national security or the health
and security of U.S. citizens living
abroad.
Once the Secretary of HHS has
declared that circumstances exist
justifying an authorization under
section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug,
device, or biological product if the
Agency concludes that the statutory
criteria are satisfied. Under section
564(h)(1) of the FD&C Act, FDA is
required to publish in the Federal
Register a notice of each authorization,
and each termination or revocation of an
authorization, and an explanation of the
reasons for the action. Under section
564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available
on the internet website of FDA. Section
564 of the FD&C Act permits FDA to
authorize the introduction into
interstate commerce of a drug, device, or
biological product intended for use in
an actual or potential emergency when
the Secretary of HHS has declared that
circumstances exist justifying the
authorization of emergency use.
Products appropriate for emergency use
may include products and uses that are
not approved, cleared, or licensed under
sections 505, 510(k), 512, or 515 of the
FD&C Act (21 U.S.C. 355, 360(k), 360b,
and 360e) or section 351 of the PHS Act
(42 U.S.C. 262), or conditionally
approved under section 571 of the FD&C
Act (21 U.S.C. 360ccc). FDA may issue
an EUA only if, after consultation with
the HHS Assistant Secretary for
Preparedness and Response, the
Director of the National Institutes of
Health, and the Director of the Centers
for Disease Control and Prevention (to
the extent feasible and appropriate
given the applicable circumstances),
1 In the case of a determination by the Secretary
of Defense, the Secretary of HHS shall determine
within 45 calendar days of such determination,
whether to make a declaration under section
564(b)(1) of the FD&C Act, and, if appropriate, shall
promptly make such a declaration.
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]]>Agencies
[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16199-16201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06034]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0902]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medication Guides for Prescription Drug Products
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed revision of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with Medication Guides for prescription drug products.
DATES: Submit either electronic or written comments on the collection
of information by May 23, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 23, 2022. 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.
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 Docket No. FDA-
2011-N-0902 for ``Agency Information Collection Activities; Proposed
Collection; Comment Request; Medication Guide Requirements for
Prescription Drug Product Labeling.'' 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, 240-402-7500.
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.govinfo.gov/content/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
[[Page 16200]]
Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
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: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2(A) of the PRA (44 U.S.C. 3506(c)(2)(A)
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed revision of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Medication Guide Requirements for Prescription Drug Product Labeling
OMB Control Number 0910-0393--Extension
This information collection supports FDA regulations pertaining to
the distribution of patient labeling, called Medication Guides, for
human prescription drug and biological products used primarily on an
outpatient basis, and required for products that pose a serious and
significant public health concern. Applicable regulations are codified
at 21 CFR part 208: Medication Guides for Prescription Drug Products,
and set forth general content and format requirements, as well as
provide for exemptions and deferrals. Medication Guides provide
patients with important written information about drug products,
including the drug's approved uses, contraindications, adverse drug
reactions, and cautions for specific populations, and are required in
accordance with Agency regulations.
To assist consumers and industry with understanding applicable
regulatory requirements in 21 CFR part 208 pertaining to developing,
distributing, and submitting certain Medication Guides, we have
developed the guidance document entitled ``Medication Guides--
Distribution Requirements and Inclusion in Risk Evaluation and
Mitigation Strategies (REMS)'' (available at https://www.fda.gov/media/79776/download). The guidance document includes a discussion of the
applicable regulations; FDA enforcement policy with regard to
Medication Guides associated with products dispensed to healthcare
professionals, or patient caregivers, instead of being dispensed
directly to the patient for self-administration; and Medication Guides
required as part of a risk evaluation and mitigation strategy.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity; 21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Content and format of a 41 1 41 320 13,120
Medication Guide; Sec. 208.20
Exemptions and deferrals; Sec. 1 1 1 4 4
208.26(a)......................
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Total....................... .............. .............. 42 .............. 13,124
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Upon evaluation of the information collection, we have removed
burden we attributed to reporting associated with supplements and other
changes to approved abbreviated new drug applications, new drug
applications, and biologics license applications (21 CFR
314.70(b)(3)(ii) and 601.12(f)). We now account for burden associated
with these regulatory provisions in OMB control numbers 0910-0001 and
0910-0338 and have decreased the burden associated with this collection
accordingly.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
Activity; 21 CFR section Number of disclosures per Total annual Average burden per disclosure \2\ Total hours
respondents respondent disclosures
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Distribute Medication Guides to authorized 191 9,000 1,719,000 1.25.................................... 2,148,750
dispensers; Sec. 208.24(c).
Distribute and Dispense Medication Guides to 88,000 5,705 502,040,000 0.05 (3 minutes)........................ 25,102,000
Patients; Sec. 208.24(e).
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Total.................................... .............. ............... 503,759,000 ........................................ 27,250,750
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers may not sum due to rounding.
[[Page 16201]]
We have decreased our estimated burden associated with disclosures
to reflect a decrease in related submissions over the past 3 years.
Dated: March 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-06034 Filed 3-21-22; 8:45 am]
BILLING CODE 4164-01-P
