Notice2021-23395
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
Primary source
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Published
October 27, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 205 (Wednesday, October 27, 2021)</title>
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[Federal Register Volume 86, Number 205 (Wednesday, October 27, 2021)]
[Notices]
[Pages 59402-59405]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23395]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0742]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Registration of
Producers of Drugs and Listing of Drugs in Commercial Distribution
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 November 26, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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 0910-0045. 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,
<a href="/cdn-cgi/l/email-protection#f6a6a4b7a582979090b6909297d89e9e85d8919980"><span class="__cf_email__" data-cfemail="3c6c6e7d6f485d5a5a7c5a585d1254544f125b534a">[email protected]</span></a>.
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.
[[Page 59403]]
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 (PHS) 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 (21 CFR 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: <a href="https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishments-current-registration-site">https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishments-current-registration-site</a>.
We have revised the information collection to include the
collection of certain information required by the Coronavirus Aid,
Relief, and Economic Security (CARES) Act (Pub. L. 116-136). Section
3112(e) of the CARES Act amended section 510(j) of the FD&C Act to
require 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 by such person for
commercial distribution. Section 510(j) of the FD&C Act, as amended by
section 3112(e) of the CARES Act, also authorizes FDA to require that
registrants report this information electronically and 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: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-drug-establishment-registration-and-drug-listing">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-drug-establishment-registration-and-drug-listing</a>. Guidance on the submission of the reporting required under
section 510(j) of the FD&C Act, as amended by section 3112(e) of the
CARES Act, is included on CDER's 2021 guidance agenda available from
our website at: <a href="https://www.fda.gov/media/134778/download">https://www.fda.gov/media/134778/download</a>. 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 21 CFR 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 (21 CFR
207.41), registrants must list each drug that it manufactures, repacks,
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).
In the Federal Register of May 10, 2021 (86 FR 24871), we published
a 60-day notice requesting public comment on the proposed collection of
information. FDA received one comment about reporting provisions newly
established by section 3112(e) of the CARES Act. Specifically, the
comment questioned the utility of information submitted by respondents
who have limited knowledge of the marketing of products and also
recommended that FDA limit reporting by certain respondents to final
retail packages intended to be marketed. We appreciate this comment and
note that we will consider the utility of this information as we
continue to implement the information collection. No comments were
received requesting that FDA revise its estimate of burden associated
with the information collection.
On our own initiative, we have downwardly revised the burden
estimate found in our 60-day notice regarding reporting elements
associated with reporting requirements under section 510(j) of the FD&C
Act. Section 510(j) provides for certain exemptions from these
reporting requirements. Specifically, section 510(j)(3)(B) of the FD&C
Act authorizes the Secretary of Health and Human Services, by order, to
exempt from some or all of these reporting requirements certain
biological products or categories of biological products regulated
under section 351 of the PHS Act if the Secretary determines that such
reporting is not necessary to protect the public health. Elsewhere in
this issue of the Federal Register, FDA is issuing a proposed order
that, if finalized, would exempt the following two categories of
biological products from such reporting requirements: (1) Blood and
blood components for transfusion, and (2) cell and gene therapy
products, where one lot treats a single patient.
We estimate the burden of the information collection as follows:
[[Page 59404]]
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity; 21 CFR section/ Number of responses per Total annual Average burden Total hours
statutory citation respondents respondent responses per response
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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 11,020 22.5 247,950 0.25 (15 61,988
information; CARES Act minutes).
section 3112.
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Total..................... .............. .............. 379,481 ................ 168,254
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Guidance recommendation Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Preparing Standard Operating Procedures for Creating and Uploading 1,000 1 1,000 40 40,000
the Structured Product Labeling File..............................
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\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
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
21 CFR 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
[[Page 59405]]
an approved drug from sale under Sec. 314.81(b)(3)(iii).
We estimate 1,000 firms will expend 40 hours to prepare, review,
and approve a standard operating procedure (SOP), for a total of 40,000
hours annually. Although we expect most respondents will have already
prepared and implemented an SOP for the electronic submission of drug
establishment registration and drug listing information, we retain an
estimate for new firms that will do so, as recommended in the guidance.
Finally, we estimate 12,800 respondents are now subject to the
reporting provisions introduced by the CARES Act under section 3112(e),
and assume it will take 15 minutes to prepare and submit the requisite
information, as shown in our 60-day notice. However, we have reduced
this figure by 1,780 to 11,020 to reflect proposed reporting exemptions
pertaining to: (1) Blood and blood components for transfusion and (2)
cell and gene therapy products, where one lot treats a single patient.
Consistent with section 510(j)(3)(B) of the FD&C Act, we have proposed
to exempt these biological product categories from the reporting
requirements in section 510(j)(3)(A) of the FD&C Act. If our proposed
order is not finalized, we will adjust our estimate accordingly upon
reevaluation of the information collection.
Overall, the information collection reflects an increase which we
attribute to the new reporting required by section 510(j) of the FD&C
Act, as amended by the CARES Act. We have otherwise retained the
currently approved burden estimates for the provisions in part 207.
Dated: October 21, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23395 Filed 10-26-21; 8:45 am]
BILLING CODE 4164-01-P
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