Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution, 24871-24874 [2021-09805]
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TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Information collection activity
Recommended information to be included when firms
choose to disseminate HCEI materials to payors about
approved prescription drugs .............................................
Recommended information to be included when firms
choose to disseminate HCEI materials to payors about
approved or cleared devices ............................................
Recommended information to be included when firms
choose to disseminate information about unapproved
products or unapproved uses of approved or cleared
products ............................................................................
Average
burden per
response
Total annual
responses
Total hours
430
10.465
4,500
20
90,000
236
10
2,360
20
47,200
717
2
1,434
0.5
(30 minutes)
717
Follow-up information to payors regarding previously communicated information about unapproved products or
unapproved uses of approved or cleared products .........
359
2
718
2
1,436
Total ..............................................................................
........................
........................
9,012
........................
139,353
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
collection associated with drug
establishment registration and product
listing requirements.
We have adjusted the estimate of
burden we associate with the
information collection
recommendations in the guidance to
reflect an increase of 2,000 hours and
100 responses annually.
Submit either electronic or
written comments on the collection of
information by July 9, 2021.
DATES:
Dated: May 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–09809 Filed 5–7–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0742]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Registration of
Producers of Drugs and Listing of
Drugs in Commercial Distribution
AGENCY:
ACTION:
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA, we, or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
SUMMARY:
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You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 9, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of July 9, 2021. 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.
ADDRESSES:
Electronic Submissions
HHS.
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Number of
responses per
respondent
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
PO 00000
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comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2011–N–0742 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Registration of Producers of Drugs and
Listing of Drugs in Commercial
Distribution.’’ 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
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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
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 extension of an
existing collection of information,
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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.
Registration of Producers of Drugs and
Listing of Drugs in Commercial
Distribution—21 CFR Part 207
OMB Control Number 0910–0045—
Revision
This information collection supports
implementation of drug establishment
registration and listing requirements
governed by FDA. These requirements
are set forth in section 510 of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360) and section
351 of the Public Health Service Act (42
U.S.C. 262) and provide for electronic
submission of information. Agency
regulations implementing these
provisions are found in part 207 (21
CFR part 207) and set forth the scope,
applicability, and content of
information to be included in
submissions. Except as provided in
§ 207.65, all information submitted
under part 207 must be transmitted to
FDA in an electronic format by using
our electronic drug registration and
listing system, in a form that we can
process, review, and archive. For more
information pertaining to drug
establishment registration and listing,
we invite you to visit our website at:
https://www.fda.gov/drugs/drugapprovals-and-databases/drugestablishments-current-registration-site.
We are revising the information
collection to include the collection of
certain information required by the
Coronavirus Aid, Relief, and Economic
Security (CARES) Act. Section 3112 of
the CARES Act requires that registrants
under section 510 of the FD&C Act must
annually report the amount of each drug
listed that was manufactured, prepared,
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propagated, compounded, or processed
for commercial distribution. Section
3112(e) also authorizes FDA to require
that registrants report this information
electronically. Finally, section 3112(e)
granted FDA the authority to require
that registrants report this information
at the time a public health emergency is
declared.
To assist respondents to the
information collection with the current
electronic reporting requirements, we
issued the guidance document entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Drug Establishment
Registration and Drug Listing’’ (June
2009), available from our website at:
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/providing-regulatorysubmissions-electronic-format-drugestablishment-registration-and-druglisting. Guidance on the submission of
the reporting required in section 3112(e)
of the CARES Act is included on CDER’s
2021 guidance agenda available from
our website at: https://www.fda.gov/
media/134778/download. Agency
guidance documents are issued
consistent with our good guidance
practice regulations in 21 CFR 10.115,
which provide for public comment at
any time.
Registration under part 207: Unless
otherwise exempt under section 510(g)
of the FD&C Act or § 207.13, all
manufacturers, repackers, relabelers,
and salvagers must register each
domestic establishment that
manufactures, repacks, relabels, or
salvages a drug, or an animal feed
bearing or containing a new animal
drug, and each foreign establishment
that manufactures, repacks, relabels, or
salvages a drug, or an animal feed
bearing or containing a new animal drug
that is imported or offered for import
into the United States. When operations
are conducted at more than one
establishment and common ownership
and control among all the
establishments exists, the parent,
subsidiary, or affiliate company may
submit registration information for all
establishments. Private label
distributors who do not also
manufacture, repack, relabel, or salvage
drugs are not required to register under
part 207. We will accept registration or
listing information submitted by a
private label distributor only if the
distributor is acting as an authorized
agent for and submitting information
that pertains to an establishment that
manufactures, repacks, relabels, or
salvages drugs.
Listing requirements under part 207:
Under § 207.41, registrants must list
each drug that it manufactures, repacks,
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relabels, or salvages for commercial
distribution. Each domestic registrant
must list each such drug regardless of
whether the drug enters interstate
commerce. When operations are
conducted at more than one
establishment, and common ownership
and control exists among all the
establishments, the parent, subsidiary,
or affiliate company may submit listing
information for any drug manufactured,
repacked, relabeled, or salvaged at any
such establishment. A drug
manufactured, repacked, or relabeled for
private label distribution must be listed
in accordance with the requirements in
§ 207.41(c).
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Information collection activity; 21 CFR/statutory
citation
Initial establishment registration; §§ 207.17,
207.21, and 207.25.
Annual review and update of registration information (including expedited updates); § 207.29.
Initial listing (including National Drug Code);
§§ 207.33, 207.41, 207.45, 207.49, 207.53,
207.54, and 207.55.
June and December review and update (or certification) of listing; §§ 207.35 and 207.57.
Waiver requests; § 207.65 ....................................
Public disclosure exemption request; § 207.81(c)
Manufacturing amount information; Section 3112
CARES Act.
Total ...............................................................
1 There
Number of
responses per
respondent
Number of
respondents
Total annual
responses
Average burden per response
Total hours
1,480
2
2,960
1 ....................................
2,960
10,000
1
10,000
0.5 (30 minutes) ...........
5,000
1,713
7.28
12,470
1.5 .................................
18,705
5,300
20
106,000
0.75 (45 minutes) .........
79,500
1
100
12,800
1
1
22.5
1
100
288,000
0.5 (30 minutes) ...........
1 ....................................
0.25 (15 minutes) .........
1
100
72,000
........................
........................
419,531
.......................................
178,266
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Preparing Standard Operating Procedures for creating and
uploading the Structured Product Labeling file ................
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1 There
Number of
records per
recordkeeper
Number of
recordkeepers
Information collection from guidance recommendations
I
1,000
I
1
Average
burden per
recordkeeping
Total annual
records
I
I
1,000
40
Total hours
I
40,000
are no capital costs or operating and maintenance costs associated with this collection of information.
According to internal data, we
estimate 1,480 respondents will submit
2,960 new establishment registrations
annually. We estimate that 10,000
registrants will provide 10,000 annual
reviews and updates of registration
information (including expedited
updates) or reviews and certifications
that no changes have occurred. The
estimates include the registration of
establishments for both domestic and
foreign manufacturers, repackers,
relabelers, and drug product salvagers,
and registration information submitted
by anyone acting as an authorized agent
for an establishment that manufactures,
repacks, relabels, or salvages drugs. The
estimates include an additional 80
positron emission tomography drug
producers who are not exempt from
registration and approximately 30
manufacturers of plasma derivatives.
We assume 1 hour is necessary for
registrants to submit initial registration
information electronically for each new
establishment. We assume 30 minutes is
necessary for each annual review and
update of registration information
(including any expedited updates) or
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each review and certification that no
changes have occurred. Our estimate
reflects the average amount of time and
effort necessary to register a domestic or
foreign establishment, and the average
amount of time and effort necessary to
review and update registration
information, or review registration
information and certify no changes have
occurred.
Based on the number of drugs listed
annually since June 2009, we estimate
1,713 registrants will report
approximately 12,469 new listings
annually (including the information
submitted to obtain a labeler code and
to reserve a National Drug Code (NDC)
for future use). Based on the number of
drugs in our listing database and the
current number of changes to listing
information submitted, we estimate
5,300 registrants will each report 20
reviews and updates (including the
information submitted to revise an NDC)
for a total of 106,000 annually. The
estimates for the number of drug listings
include both domestic and foreign
listings, listings submitted by registrants
for products sold under their own
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names as well as products intended for
private label distribution, and
information submitted related to an
NDC and to obtain a labeler code. The
estimate for the number of drugs subject
to the listing requirements includes
positron emission tomography drugs
and approximately 30 plasma
derivatives. The estimates for the
number of June and December reviews
and updates of listing information
include the number of changes to drug
characteristics pertaining to the drug
product code to obtain a new NDC and
the reports of the withdrawal of an
approved drug from sale under
§ 314.81(b)(3)(iii) (21 CFR
314.81(b)(3)(iii)).
Based on our experience with
electronically listing submissions since
June 2009, we assume it takes 1 hour
and 30 minutes to submit information
electronically for each drug listed for
the first time (for both foreign and
domestic registrant listings). These
estimates are an average of the time it
will take manufacturers, repackers,
relabelers, and drug product salvagers,
with drug product salvagers taking
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considerably less time than
manufacturers. The estimates include
the time for submitting the content of
labeling and other labeling in an
electronic format (for drugs subject to an
approved marketing application, the
electronic submission of the content of
labeling under § 314.50(l)(1)(i) is
approved under OMB control number
0910–0001). We assume it takes 45
minutes for each June and December
review and update. These estimates
represent the average amount of time to
review and update listing information or
to review and certify that no changes
have occurred. The estimates include
the time for submitting any labeling for
each drug, changes to the drug’s
characteristics submitted for a new
NDC, and reports of the withdrawal of
an approved drug from sale under
§ 314.81(b)(3)(iii).
Finally, although we expect most
respondents will already have prepared
a standard operating procedure (SOP)
for the electronic submission of drug
establishment registration and drug
listing information, we estimate each
year additional firms will need to create
an SOP as recommended in the
guidance. We therefore estimate 1,000
firms will expend approximately 40
hours to prepare, review, and approve
an SOP, for a total of 40,000 hours
annually.
While we retain the currently
approved burden estimates for
information collection associated with
provisions in part 207, we have adjusted
our estimate upward by 72,000 hours
and 288,000 responses to account for
information collection associated with
the new manufacturing amount
information element required by the
CARES Act.
Dated: May 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–09805 Filed 5–7–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
khammond on DSKJM1Z7X2PROD with NOTICES
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of
meetings of the Board of Scientific
Counselors, NHLBI.
The meetings will be closed to the
public as indicated below in accordance
with the provisions set forth in section
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552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
NATIONAL HEART, LUNG, AND
BLOOD INSTITUTE, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, NHLBI.
Date: June 4, 2021.
Time: 9:55 a.m. to 4:00 p.m.
Agenda: To review and evaluate to review
and evaluate personnel qualifications and
performance, and competence of individual
investigators.
Place: National Institutes of Health,
Building, 10, 10 Center Drive Bethesda, MD
20892 (Virtual Meeting).
Date: June 7, 2021.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate to review
and evaluate personnel qualifications and
performance, and competence of individual
investigators.
Place: National Institutes of Health,
Building 10, 10 Center Drive Bethesda, MD
20892 (Virtual Meeting).
Contact Person: Robert S. Balaban, Ph.D.,
Scientific Director, Division of Intramural
Research, National Institutes of Health,
NHLBI, Building 10, CRC, 4th Floor, Room
1581, 10 Center Drive, Bethesda, MD 20892,
301/496–2116.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person. These
meetings are closed to the public.
Information is also available on the
Institute’s/Center’s home page:
www.nhlbi.nih.gov/meetings/index.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: May 5, 2021.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–09839 Filed 5–7–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Mental Health Initial Review Group; Mental
Health Services Study Section.
Date: June 10–11, 2021.
Time: June 10, 2021, 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Time: June 11, 2021, 11:00 a.m. to 3:00
p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Aileen Schulte, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6136, MSC 9606,
Bethesda, MD 20852 301–443–1225,
aschulte@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: May 5, 2021.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–09813 Filed 5–7–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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]]>Agencies
[Federal Register Volume 86, Number 88 (Monday, May 10, 2021)]
[Notices]
[Pages 24871-24874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09805]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0742]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Registration of Producers of Drugs and Listing of
Drugs in Commercial Distribution
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
associated with drug establishment registration and product listing
requirements.
DATES: Submit either electronic or written comments on the collection
of information by July 9, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 9, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 9, 2021. 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 the Docket No.
FDA-2011-N-0742 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Registration of Producers of
Drugs and Listing of Drugs in Commercial Distribution.'' 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
[[Page 24872]]
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 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 extension 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.
Registration of Producers of Drugs and Listing of Drugs in Commercial
Distribution--21 CFR Part 207
OMB Control Number 0910-0045--Revision
This information collection supports implementation of drug
establishment registration and listing requirements governed by FDA.
These requirements are set forth in section 510 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360) and section 351 of
the Public Health Service Act (42 U.S.C. 262) and provide for
electronic submission of information. Agency regulations implementing
these provisions are found in part 207 (21 CFR part 207) and set forth
the scope, applicability, and content of information to be included in
submissions. Except as provided in Sec. 207.65, all information
submitted under part 207 must be transmitted to FDA in an electronic
format by using our electronic drug registration and listing system, in
a form that we can process, review, and archive. For more information
pertaining to drug establishment registration and listing, we invite
you to visit our website at: https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishments-current-registration-site.
We are revising the information collection to include the
collection of certain information required by the Coronavirus Aid,
Relief, and Economic Security (CARES) Act. Section 3112 of the CARES
Act requires that registrants under section 510 of the FD&C Act must
annually report the amount of each drug listed that was manufactured,
prepared, propagated, compounded, or processed for commercial
distribution. Section 3112(e) also authorizes FDA to require that
registrants report this information electronically. Finally, section
3112(e) granted FDA the authority to require that registrants report
this information at the time a public health emergency is declared.
To assist respondents to the information collection with the
current electronic reporting requirements, we issued the guidance
document entitled ``Providing Regulatory Submissions in Electronic
Format--Drug Establishment Registration and Drug Listing'' (June 2009),
available from our website at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-drug-establishment-registration-and-drug-listing. Guidance on the submission of the reporting required in
section 3112(e) of the CARES Act is included on CDER's 2021 guidance
agenda available from our website at: https://www.fda.gov/media/134778/download. Agency guidance documents are issued consistent with our good
guidance practice regulations in 21 CFR 10.115, which provide for
public comment at any time.
Registration under part 207: Unless otherwise exempt under section
510(g) of the FD&C Act or Sec. 207.13, all manufacturers, repackers,
relabelers, and salvagers must register each domestic establishment
that manufactures, repacks, relabels, or salvages a drug, or an animal
feed bearing or containing a new animal drug, and each foreign
establishment that manufactures, repacks, relabels, or salvages a drug,
or an animal feed bearing or containing a new animal drug that is
imported or offered for import into the United States. When operations
are conducted at more than one establishment and common ownership and
control among all the establishments exists, the parent, subsidiary, or
affiliate company may submit registration information for all
establishments. Private label distributors who do not also manufacture,
repack, relabel, or salvage drugs are not required to register under
part 207. We will accept registration or listing information submitted
by a private label distributor only if the distributor is acting as an
authorized agent for and submitting information that pertains to an
establishment that manufactures, repacks, relabels, or salvages drugs.
Listing requirements under part 207: Under Sec. 207.41,
registrants must list each drug that it manufactures, repacks,
[[Page 24873]]
relabels, or salvages for commercial distribution. Each domestic
registrant must list each such drug regardless of whether the drug
enters interstate commerce. When operations are conducted at more than
one establishment, and common ownership and control exists among all
the establishments, the parent, subsidiary, or affiliate company may
submit listing information for any drug manufactured, repacked,
relabeled, or salvaged at any such establishment. A drug manufactured,
repacked, or relabeled for private label distribution must be listed in
accordance with the requirements in Sec. 207.41(c).
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Information collection Number of
activity; 21 CFR/statutory Number of responses per Total annual Average burden Total hours
citation respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Initial establishment 1,480 2 2,960 1............... 2,960
registration; Sec. Sec.
207.17, 207.21, and 207.25.
Annual review and update of 10,000 1 10,000 0.5 (30 minutes) 5,000
registration information
(including expedited
updates); Sec. 207.29.
Initial listing (including 1,713 7.28 12,470 1.5............. 18,705
National Drug Code); Sec.
Sec. 207.33, 207.41,
207.45, 207.49, 207.53,
207.54, and 207.55.
June and December review and 5,300 20 106,000 0.75 (45 79,500
update (or certification) of minutes).
listing; Sec. Sec. 207.35
and 207.57.
Waiver requests; Sec. 207.65 1 1 1 0.5 (30 minutes) 1
Public disclosure exemption 100 1 100 1............... 100
request; Sec. 207.81(c).
Manufacturing amount 12,800 22.5 288,000 0.25 (15 72,000
information; Section 3112 minutes).
CARES Act.
---------------------------------------------------------------------------------
Total..................... .............. .............. 419,531 ................ 178,266
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Information collection from guidance recommendations Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Preparing Standard Operating Procedures for creating and uploading 1,000 1 1,000 40 40,000
the Structured Product Labeling file..............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
According to internal data, we estimate 1,480 respondents will
submit 2,960 new establishment registrations annually. We estimate that
10,000 registrants will provide 10,000 annual reviews and updates of
registration information (including expedited updates) or reviews and
certifications that no changes have occurred. The estimates include the
registration of establishments for both domestic and foreign
manufacturers, repackers, relabelers, and drug product salvagers, and
registration information submitted by anyone acting as an authorized
agent for an establishment that manufactures, repacks, relabels, or
salvages drugs. The estimates include an additional 80 positron
emission tomography drug producers who are not exempt from registration
and approximately 30 manufacturers of plasma derivatives.
We assume 1 hour is necessary for registrants to submit initial
registration information electronically for each new establishment. We
assume 30 minutes is necessary for each annual review and update of
registration information (including any expedited updates) or each
review and certification that no changes have occurred. Our estimate
reflects the average amount of time and effort necessary to register a
domestic or foreign establishment, and the average amount of time and
effort necessary to review and update registration information, or
review registration information and certify no changes have occurred.
Based on the number of drugs listed annually since June 2009, we
estimate 1,713 registrants will report approximately 12,469 new
listings annually (including the information submitted to obtain a
labeler code and to reserve a National Drug Code (NDC) for future use).
Based on the number of drugs in our listing database and the current
number of changes to listing information submitted, we estimate 5,300
registrants will each report 20 reviews and updates (including the
information submitted to revise an NDC) for a total of 106,000
annually. The estimates for the number of drug listings include both
domestic and foreign listings, listings submitted by registrants for
products sold under their own names as well as products intended for
private label distribution, and information submitted related to an NDC
and to obtain a labeler code. The estimate for the number of drugs
subject to the listing requirements includes positron emission
tomography drugs and approximately 30 plasma derivatives. The estimates
for the number of June and December reviews and updates of listing
information include the number of changes to drug characteristics
pertaining to the drug product code to obtain a new NDC and the reports
of the withdrawal of an approved drug from sale under Sec.
314.81(b)(3)(iii) (21 CFR 314.81(b)(3)(iii)).
Based on our experience with electronically listing submissions
since June 2009, we assume it takes 1 hour and 30 minutes to submit
information electronically for each drug listed for the first time (for
both foreign and domestic registrant listings). These estimates are an
average of the time it will take manufacturers, repackers, relabelers,
and drug product salvagers, with drug product salvagers taking
[[Page 24874]]
considerably less time than manufacturers. The estimates include the
time for submitting the content of labeling and other labeling in an
electronic format (for drugs subject to an approved marketing
application, the electronic submission of the content of labeling under
Sec. 314.50(l)(1)(i) is approved under OMB control number 0910-0001).
We assume it takes 45 minutes for each June and December review and
update. These estimates represent the average amount of time to review
and update listing information or to review and certify that no changes
have occurred. The estimates include the time for submitting any
labeling for each drug, changes to the drug's characteristics submitted
for a new NDC, and reports of the withdrawal of an approved drug from
sale under Sec. 314.81(b)(3)(iii).
Finally, although we expect most respondents will already have
prepared a standard operating procedure (SOP) for the electronic
submission of drug establishment registration and drug listing
information, we estimate each year additional firms will need to create
an SOP as recommended in the guidance. We therefore estimate 1,000
firms will expend approximately 40 hours to prepare, review, and
approve an SOP, for a total of 40,000 hours annually.
While we retain the currently approved burden estimates for
information collection associated with provisions in part 207, we have
adjusted our estimate upward by 72,000 hours and 288,000 responses to
account for information collection associated with the new
manufacturing amount information element required by the CARES Act.
Dated: May 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-09805 Filed 5-7-21; 8:45 am]
BILLING CODE 4164-01-P
