[Federal Register Volume 86, Number 205 (Wednesday, October 27, 2021)]
[Notices]
[Pages 59402-59405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0045. 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, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

[[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: https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishments-current-registration-site.
    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: 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 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: 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 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\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
   Activity; 21 CFR section/       Number of     responses per   Total annual    Average burden     Total hours
      statutory 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                    11,020            22.5         247,950  0.25 (15                  61,988
 information; CARES Act                                                          minutes).
 section 3112.
                               ---------------------------------------------------------------------------------
    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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                       Average burden
                      Guidance recommendation                           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 
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


