83 FR 26392 - Product Jurisdiction; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 110 (June 7, 2018)

Page Range		26392-26392
FR Document		2018-12201

The Food and Drug Administration is correcting a proposed rule to amend its regulations concerning the classification of products as biological products, devices, drugs, or combination products, and their assignment to Agency components for premarket review and regulation that appeared in the Federal Register of May 15, 2018. The document was published with an error in the discussion of the preliminary economic analysis impact. This document corrects that error.

Federal Register, Volume 83 Issue 110 (Thursday, June 7, 2018)

[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Proposed Rules]
[Page 26392]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12201]



[[Page 26392]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 3

[Docket No. FDA-2004-N-0191]


Product Jurisdiction; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; correction.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration is correcting a proposed rule 
to amend its regulations concerning the classification of products as 
biological products, devices, drugs, or combination products, and their 
assignment to Agency components for premarket review and regulation 
that appeared in the Federal Register of May 15, 2018. The document was 
published with an error in the discussion of the preliminary economic 
analysis impact. This document corrects that error.

DATES: Submit either electronic or written comments on the proposed 
rule by July 16, 2018.

FOR FURTHER INFORMATION CONTACT: Melissa Burns, Office of Combination 
Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 5129, Silver Spring, MD 20933, 301-796-8930, 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, May 15, 
2018, beginning on page 22428 for FR Doc. 2018-10321, table 1 on page 
22433 is corrected to read:

                                      Table 1--Benefits, Costs, and Distributional Effects of the Proposed Rule 1 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                 Units
                                                                                ---------------------------------------
                Category                    Primary        Low          High                                  Period                  Notes
                                            estimate     estimate     estimate       Year       Discount     covered
                                                                                   dollars     rate  (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized..........................      $17,000      $12,000      $27,000         2016            7           10  ................................
    Monetized $/year....................       15,000       10,000       23,000         2016            3           10  ................................
    Annualized..........................  ...........  ...........  ...........  ...........            7  ...........
    Quantified..........................  ...........  ...........  ...........  ...........            3  ...........
    Qualitative.........................  ...........  ...........  ...........  ...........  ...........  ...........
Benefits:
    Annualized..........................       28,000       25,000       89,000         2016            7           10  ................................
    Monetized $/year....................       28,000       25,000       89,000         2016            3           10  ................................
    Annualized..........................  ...........  ...........  ...........  ...........            7  ...........  ................................
    Quantified..........................  ...........  ...........  ...........  ...........            3  ...........  ................................
                                         ---------------------------------------
    Qualitative.........................    Firms and FDA may realize savings    ...........  ...........  ...........  ................................
                                             from sponsors choosing to submit
                                                     electronic RFDs
                                         ---------------------------------------
Transfers:
    Federal.............................  ...........  ...........  ...........  ...........            7  ...........  ................................
    Annualized                            ...........  ...........  ...........  ...........  ...........  ...........  ................................
    Monetized $millions/year............  ...........  ...........  ...........  ...........            3  ...........  ................................
                                         ------------------------------------------------------------------------------
    From/To.............................  From:
                                          To:
                                         ------------------------------------------------------------------------------
    Other...............................  ...........  ...........  ...........  ...........            7  ...........  ................................
    Annualized..........................
    Monetized $millions/year............  ...........  ...........  ...........  ...........            3  ...........  ................................
                                         ------------------------------------------------------------------------------
    From/To.............................  From:
                                          To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government:..................................................................................................................
    Small Business: Will not have a significant impact on a substantial number of small entities........................................................
    Wages:..............................................................................................................................................
    Growth:.............................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ We use a 10-year time horizon for this rule with payments occurring at the end of each period.
\2\ All dollar values are rounded to the nearest $1,000.


    Dated: June 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12201 Filed 6-6-18; 8:45 am]
BILLING CODE 4164-01-P

26392 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Proposed Rules

DEPARTMENT OF HEALTH AND rule to amend its regulations concerning FOR FURTHER INFORMATION CONTACT:
HUMAN SERVICES the classification of products as Melissa Burns, Office of Combination
biological products, devices, drugs, or Products, Food and Drug
Food and Drug Administration combination products, and their Administration, 10903 New Hampshire
assignment to Agency components for Ave., Bldg. 32, Rm. 5129, Silver Spring,
21 CFR Part 3 premarket review and regulation that MD 20933, 301–796–8930,
[Docket No. FDA–2004–N–0191] appeared in the Federal Register of May melissa.burns@fda.hhs.gov.
15, 2018. The document was published
Product Jurisdiction; Correction SUPPLEMENTARY INFORMATION: In the
with an error in the discussion of the
Federal Register of Tuesday, May 15,
AGENCY: Food and Drug Administration, preliminary economic analysis impact.
2018, beginning on page 22428 for FR
HHS. This document corrects that error.
Doc. 2018–10321, table 1 on page 22433
ACTION: Proposed rule; correction. DATES: Submit either electronic or is corrected to read:
written comments on the proposed rule
SUMMARY: The Food and Drug
Administration is correcting a proposed by July 16, 2018.

TABLE 1—BENEFITS, COSTS, AND DISTRIBUTIONAL EFFECTS OF THE PROPOSED RULE 1 2
Units
Primary Low High
Category Discount Period Notes
estimate estimate estimate Year rate covered
dollars (%) (years)

Costs:
Annualized ................................. $17,000 $12,000 $27,000 2016 7 10
Monetized $/year ....................... 15,000 10,000 23,000 2016 3 10
Annualized ................................. .................... .................... .................... .................... 7 ....................
Quantified ................................... .................... .................... .................... .................... 3 ....................
Qualitative .................................. .................... .................... .................... .................... .................... ....................
Benefits:
Annualized ................................. 28,000 25,000 89,000 2016 7 10
Monetized $/year ....................... 28,000 25,000 89,000 2016 3 10
Annualized ................................. .................... .................... .................... .................... 7 ....................
Quantified ................................... .................... .................... .................... .................... 3 ....................

Qualitative .................................. Firms and FDA may realize savings from .................... .................... ....................
sponsors choosing to submit electronic
RFDs

Transfers:
Federal ....................................... .................... .................... .................... .................... 7 ....................
Annualized .................... .................... .................... .................... .................... ....................
Monetized $millions/year ........... .................... .................... .................... .................... 3 ....................

From/To ..................................... From: To:

Other .......................................... .................... .................... .................... .................... 7 ....................
Annualized.
Monetized $millions/year ........... .................... .................... .................... .................... 3 ....................

From/To ..................................... From: To:

Effects:
State, Local or Tribal Government:
Small Business: Will not have a significant impact on a substantial number of small entities.
Wages:
Growth:
1 We use a 10-year time horizon for this rule with payments occurring at the end of each period.
2 All dollar values are rounded to the nearest $1,000.

Dated: June 1, 2018. POSTAL REGULATORY COMMISSION SUMMARY: The Commission is noticing a
Leslie Kux, recent filing requesting that the
39 CFR Part 3050
sradovich on DSK3GMQ082PROD with PROPOSALS

Associate Commissioner for Policy. Commission initiate an informal
[FR Doc. 2018–12201 Filed 6–6–18; 8:45 am] rulemaking proceeding to consider
BILLING CODE 4164–01–P
[Docket No. RM2018–5; Order No. 4630] changes to an analytical method for use
in periodic reporting (Proposal Two).
Periodic Reporting This document informs the public of the
filing, invites public comment, and
AGENCY: Postal Regulatory Commission.
takes other administrative steps.
ACTION: Notice of proposed rulemaking.

VerDate Sep<11>2014 16:26 Jun 06, 2018 Jkt 244001 PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 E:\FR\FM\07JNP1.SGM 07JNP1

Document Created: 2018-06-07 00:50:39
Document Modified: 2018-06-07 00:50:39

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Proposed rule; correction.
Dates		Submit either electronic or written comments on the proposed rule by July 16, 2018.
Contact		Melissa Burns, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20933, 301-796-8930, [email protected]
FR Citation		83 FR 26392

83 FR 26392 - Product Jurisdiction; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 110 (June 7, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration