[Federal Register Volume 86, Number 242 (Tuesday, December 21, 2021)]
[Notices]
[Pages 72266-72267]
[FR Doc No: 2021-27606]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2021-0002; Internal Agency Docket No. FEMA-B-2186]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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

SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP).

DATES: Comments are to be submitted on or before March 21, 2022.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location https://hazards.fema.gov/femaportal/prelimdownload and the
respective Community Map Repository address listed in the tables below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-2186, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC
20472,<PHONE_NUMBER>, or (email) [email protected].

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location
https://hazards.fema.gov/femaportal/prelimdownload and the respective
Community Map Repository address listed in the tables. For communities
with multiple ongoing Preliminary studies, the studies can be
identified by the unique project number and Preliminary FIRM date
listed in the tables. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at https://msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
            Buchanan County, Missouri and Incorporated Areas
          Project: 19-07-0077S Preliminary Date: April 30, 2021
------------------------------------------------------------------------
City of Easton.........................  City Hall, 106 North Woodward
                                          Street, Easton, MO 64443.
City of Rushville......................  Buchanan County Emergency
                                          Management Office, Room 102,
                                          411 Jules Street, St. Joseph,
                                          MO 64501.
City of St. Joseph.....................  City Hall, 1100 Frederick
                                          Avenue, Room 107, St. Joseph,
                                          MO 64501.
Town of Agency.........................  Buchanan County Emergency
                                          Management Office, Room 102,
                                          411 Jules Street, St. Joseph,
                                          MO 64501.
Village of Lewis and Clark.............  Lewis and Clark Village Hall,
                                          101 Lakeshore Drive,
                                          Rushville, MO 64484.
Unincorporated Areas of Buchanan County  Buchanan County Emergency
                                          Management Office, Room 102,
                                          411 Jules Street, St. Joseph,
                                          MO 64501.
------------------------------------------------------------------------
             Pettis County, Missouri and Incorporated Areas
         Project: 18-07-0018S Preliminary Date: October 1, 2021
------------------------------------------------------------------------
City of Sedalia........................  City Hall, 200 South Osage
                                          Avenue, Sedalia, MO 65301.
Unincorporated Areas of Pettis County..  Pettis County Courthouse, 415
                                          South Ohio Avenue, Suite 212,
                                          Sedalia, MO 65301.
------------------------------------------------------------------------
              Clinton County, New York (All Jurisdictions)
         Project: 18-02-0003S Preliminary Date: August 10, 2021
------------------------------------------------------------------------
Town of Altona.........................  Town Hall, 3124 Miner Farm
                                          Road, Altona, NY 12910.
Town of Black Brook....................  Black Brook Town Hall, 18 North
                                          Main Street, Ausable, NY
                                          12912.
Town of Champlain......................  Town Hall, 10729 State Route 9,
                                          Champlain, NY 12919.
Town of Chazy..........................  Town Hall, 9631 State Route 9,
                                          Chazy, NY 12921.
Town of Clinton........................  Clinton Town Hall, 23 Smith
                                          Street, Churubusco, NY 12923.
Town of Dannemora......................  Dannemora Town Court, 78 Higby
                                          Road, Ellenburg Depot, NY
                                          12935.
Town of Ellenburg......................  Ellenburg Town Municipal
                                          Building, 16 Saint Edmunds
                                          Way, Ellenburg Center, NY
                                          12934.
Town of Mooers.........................  Town Hall, 2508 State Route 11,
                                          Mooers, NY 12958.
Town of Peru...........................  Town Hall, 3036 Main Street,
                                          Peru, NY 12972.
Town of Plattsburgh....................  Town Hall, 151 Banker Road,
                                          Plattsburgh, NY 12901.
Town of Saranac........................  Town Hall, 3662 Route 3,
                                          Saranac, NY 12981.
Town of Schuyler Falls.................  Schuyler Falls Town Hall, 997
                                          Mason Street, Morrisonville,
                                          NY 12962.
Village of Champlain...................  Village of Champlain Office,
                                          11104 State Route 9,
                                          Champlain, NY 12919.
------------------------------------------------------------------------

[FR Doc. 2021-27606 Filed 12-20-21; 8:45 am]
BILLING CODE 9110-12-P


would not contain all elements required
on licensed, approved, or cleared
product labels.
For example, certain information may
not be available until after approval of
the product. For licensed biological
products, §610.60 (21 CFR 610.60)
requires the container label to include,
among other things, the expiration date
of the product and license number of
the manufacturer. Similarly, §201.17
(21 CFR 201.17), which applies to drugs,
sets forth requirements regarding
placement of an expiration date, when
required, on the immediate container.
This information may not be available
for an investigational product and thus
could not be placed on container labels
if the investigational product was added
to the SNS. (See section III.D of this
document for a discussion of conditions
or safeguards that may be imposed in
connection with an alternative or
exception granted under this rule to
ensure that labeling includes
information necessary for safe and
effective use of the product.)
Similarly, for medical devices that are
restricted to use by prescription,
§801.109 (21 CFR 801.109) requires that
the device label, other than for surgical
instruments, bear a statement restricting
sale of the device by order of a
healthcare practitioner licensed by the
law of the State in which he practices
(§801.109(b)(1)). Whether a particular
investigational device will be limited to
sale by prescription may not be known
before approval or clearance and, thus,
this statement could not be placed on
the investigational device’s label if the
product was still investigational when
the device was added to the SNS.
Additionally, the label of approved or
cleared in vitro diagnostic products
(IVDs) must contain information, such
as warnings for users and storage
instructions, that may not be finalized
until product approval or clearance and
could not be placed on the label if the
investigational products were added to
the SNS (see §809.10).
Prior to the implementation of this
rule, when such investigational
products were ultimately approved for
marketing, the products would have
been subject to relabeling, a potentially
time-consuming, costly, and labor-
intensive process given that the SNS can
contain large numbers of these products.
The SNS does not have manufacturing
facilities or equipment necessary to
relabel products that the SNS stores.
Therefore, it is not feasible for SNS
personnel to relabel products that are
physically located in SNS storage sites.
Prior to the implementation of this rule,
the products would have needed to be
returned to the manufacturers or sent to
relabelers in order to be relabeled.
Requiring relabeling of such
investigational medical products after
approval, licensure, or clearance could
adversely affect the safety, effectiveness,
or availability of these medical products
in a number of ways. For example,
shipping certain products from the SNS
storage sites to the manufacturer or a
relabeler for relabeling could subject
them to unacceptable temperature
deviations and create opportunities for
product mishandling, such as mixing of
different batches of the same product.
Relabeling is especially difficult for
certain products that must be stored at
extremely low temperatures. In some
instances, relabeling could cause the
product to be unavailable for
dispensing, delay deployment of the
product for use, or could result in
reduced product quality (e.g., potency
or stability) and the loss of critical
products. Security issues may also affect
availability, as there is the potential for
sabotage and diversion if a product were
shipped back to the manufacturer or to
a relabeler.
For these reasons, as explained in the
following section of this document, this
rule allows FDA Center Directors to
grant exceptions or alternatives to
certain labeling requirements not
explicitly required by statute for
medical products that are or will be
included in the SNS.
III. Provisions of the Interim Final Rule
A. Applicability of a Request for an
Exception or Alternative
Under §§201.26, 610.68, 801.128, and
809.11 (21 CFR 201.26, 610.68, 801.128,
and 809.11), the appropriate FDA Center
Director may grant a request for an
exception or alternative to certain
regulatory provisions pertaining to the
labeling of human drugs, biological
products, and medical devices that
currently are or will be included in the
SNS if certain criteria are met. Any
grant of an exception or alternative will
only apply to the specified lots, batches,
or other units of medical products in the
request. We request comments on
whether the scope of the rule should be
amended to extend to medical products
in other Federal, State, and local
stockpiles, and if so, to which
stockpile(s) the rule should apply.
The appropriate FDA Center Director
will only review requests for exceptions
or alternatives to the labeling provisions
specified in this rule. The rule is not
intended to provide a mechanism for
waiving applicable requirements of
sections 502 and 503 (21 U.S.C. 353) of
the FFD&C Act and/or section 351 of the
PHS Act. For example, under this new
rule, an SNS official (or a manufacturer
with an SNS official’s written
concurrence) may submit to FDA a
request for an exception or alternative to
a regulatory provision identified in this
rule, such as where an expiration date
may be placed under §201.17, but not
to the requirements under the PHS Act
that the package (not necessarily the
container) of a biological product be
plainly marked with the product’s
expiration date (section 351(a)(1)(B)(iii)
of the PHS Act (42 U.S.C.
262(a)(1)(B)(iii))). To the extent that a
request for an exception or alternative to
labeling requirements under this rule
implicates other regulations not
specified in this rule (e.g., regulations in
21 CFR part 211, Current Good
Manufacturing Practice for Finished
Pharmaceuticals) or involves statutory
requirements, FDA will limit its
consideration of the exception or
alternative request to the labeling
provisions specified in this rule. The
remaining portions of such a request or
VerDate Aug<31>2005
23:53 Dec 27, 2007
Jkt 214001
PO 00000
Frm 00019
Fmt 4700
Sfmt 4700
E:\FR\FM\28DER1.SGM
28DER1

73592
Federal Register/Vol. 72, No. 248 /Friday, December 28, 2007 /Rules and Regulations
other requests (i.e., those that do not
involve the labeling provisions specified
in this rule) will be reviewed under
other applicable waiver provisions, if
any.
We note that FDA’s authority to grant
an exception or alternative to the
regulatory provisions specified in the
rule is distinct from the agency’s
authority to exercise enforcement
discretion (i.e., decide not to take or
recommend enforcement action) with
respect to statutory and regulatory
requirements, including those involving
product labeling (see Heckler v. Chaney,
470 U.S. 821 (1985)).
In granting an exception or alternative
under this rule, the appropriate FDA
Center Director will consider whether
compliance with the labeling
requirements specified in this rule
could adversely affect the safety,
effectiveness, or availability of medical
products that are or will be included in
the SNS. As previously explained in
this document, relabeling these medical
products in compliance with certain
FDA labeling regulations could
adversely affect the safety, effectiveness,
or availability of the products in some
circumstances. In those instances, the
appropriate FDA Center Director may
grant an exception or alternative to the
labeling requirements specified in this
rule. On the other hand, there may be
some products for which full or partial
relabeling in compliance with the
labeling requirements specified by this
rule will not adversely affect the safety,
effectiveness, or availability of the
products. In such cases, an exception or
alternative to the labeling requirements
specified in this rule would not be
warranted.
On a case-by-case basis, the
appropriate FDA Center Director may
also determine when an exception or
alternative is granted that certain
safeguards and conditions are
appropriate, such as additional labeling
on the SNS products, so that the
labeling of such products would include
information needed for safe and
effective use under the anticipated
circumstances of use.
B. Who May Submit a Request
A request for an exception or
alternative to the labeling requirements
specified in this rule may be submitted
by an SNS official, or by any entity that
manufactures (including labeling,
packing, repackaging, or relabeling),
distributes, or stores the medical
products subject to the request. Requests
from entities other than the SNS must
be submitted with an SNS official’s
written concurrence. We believe that
many of the requests under this rule
will be submitted by manufacturers,
with concurrence of SNS officials, prior
to or at the time a specified lot, batch,
or other unit of product is procured by
the SNS, or when an investigational
product held in the SNS has been
approved, licensed, or cleared. We
anticipate that SNS officials will also
submit requests.
The appropriate FDA Center Director
may also grant an exception or
alternative to the labeling provisions
specified in this rule at his or her own
initiative.
C. Request Criteria
Except when initiated by an FDA
Center Director, a request for an
exception or alternative to the labeling
requirements specified in this rule will
be in writing and must contain:
•
An identification of the specific lot,
batch, or other unit of product, which
are or will be in the SNS, that would be
subject to the exception or alternative;
•
An identification of the specific
labeling provisions under this rule that
are the subject of the request;
•
An explanation of why compliance
with the specified labeling provisions
could adversely affect the safety,
effectiveness, or availability of the
product subject to the request;
•
A description of any proposed
safeguards or conditions to be
implemented so that the labeling of the
product includes appropriate
information necessary for the safe and
effective use of the product given the
anticipated circumstances of use;
•
Copies of the proposed labeling of
the specified lots, batches, or other units
of product that will be subject to the
exception or alternative; and
•
Any other information requested by
the appropriate FDA Center Director.
D. Granting of the Request
When the appropriate FDA Center
Director grants or denies a request for an
exception or alternative to the labeling
requirements specified in this rule, the
FDA Center Director will convey this
decision in writing. In the written
decision, the FDA Center Director may
also impose appropriate conditions or
safeguards so that the labeling of the
product includes appropriate
information necessary for the safe and
effective use of the product given the
anticipated circumstances of use. Such
safeguards or conditions need not be
limited to those proposed in the request,
nor do they need to include all
conditions or safeguards proposed in
the request. Conditions could include,
for example, a requirement of additional
labeling on the SNS product, such as
including the statement ‘‘For Strategic
National Stockpile Use Only’’ on the
label or elsewhere within the product’s
labeling. Such conditions could also
address how or where any packaging or
labeling changes would be conducted,
or with what personnel. For example,
the manufacturer may be required to
take additional steps to ensure that
products licensed, approved, or cleared
while in the SNS bear information in
their outer package labeling that was not
available when such products entered
the SNS as investigational products.
After the request is granted, the
manufacturer may need to report to FDA
any resulting changes to the New Drug
Application (NDA), Biologics License
Application (BLA), Premarket Approval
Application (PMA), or Premarket
Notification (510(k)) in effect, if any.
The submission and grant of a request
for an exception or alternative to the
labeling requirements specified in this
rule may be used to satisfy certain
reporting obligations relating to changes
to product applications under §314.70
(21 CFR 314.70) (human drugs), §601.12
(21 CFR 601.12) (biological drugs),
§814.39 (21 CFR 814.39) (medical
devices subject to premarket approval),
or §807.81 (21 CFR 807.81) (medical
devices subject to premarket notification
submission (510(k) clearance)
requirements). Specifically, because the
information affecting the premarket
application will already be reviewed
and approved as part of the request for
an exception or alternative,
manufacturers of medical products to
which annual or periodic reporting
requirements apply must describe such
changes in their annual (or periodic)
reports but are not required to submit
supplement(s) to an approved
application describing this information.
This will reduce regulatory burden on
industry by reducing duplication of
regulatory submissions. Supplements
under 21 CFR 814.39 and periodic
reports under §814.84 are not required
for medical devices with 510(k)
clearance, however. For these devices,
the Center Director may determine that
the submission and grant of a written
request for an exception or alternative
under this rule satisfies the 510(k)
submission requirements in
§807.81(a)(3).
E. Labeling Provisions Subject to
Exception or Alternative
We are listing in §§201.26(f) (human
drug products), 610.68(f) (biological
products), 801.128(f) (medical devices),
and 809.11(f) (in vitro diagnostic
products) those labeling provisions for
which the appropriate FDA Center
Director may grant an exception or
alternative. As indicated in section III.A
VerDate Aug<31>2005
23:53 Dec 27, 2007
Jkt 214001
PO 00000
Frm 00020
Fmt 4700
Sfmt 4700
E:\FR\FM\28DER1.SGM
28DER1

73593
Federal Register/Vol. 72, No. 248 /Friday, December 28, 2007 /Rules and Regulations
2
This is distinct from the requirements for a
product’s package label under §610.61 (21 CFR
610.61).
of this document, requests for
exceptions or alternatives to other
requirements of FDA’s labeling
regulations (such as bar code label
requirements), or to other general
regulations or statutory provisions, will
be handled under any waiver provisions
that may be applicable to those statutory
or regulatory requirements.
Additionally, FDA may exercise
enforcement discretion with respect to
the labeling requirements specified in
this rule or other regulatory and
statutory requirements.
1. Human Drug Products (§201.26(f))
For human drug products, including
biological drugs, the following
requirements pertaining to labeling in
part 201, subpart A (21 CFR part 201,
subpart A) and §312.6 (21 CFR 312.6)
may be the subject of an exception or
alternative under this rule, except to the
extent that they are explicitly required
by statute:
•
Identification of persons other than
the manufacturer, packer, or distributor
(§201.1(h)(1));
•
Appearance of a person’s name
without qualification on the label
(§201.1(h)(2));
•
Appropriate qualifying phrases for
the identity of the distributor or packer
(§201.1(h)(5) and (h)(6));
•
Criteria for the statement of the
place of business (§201.1(i));
•
Placement of the ingredient
information required by section 502(e)
of the FFD&C Act (§201.10(a));
•
Criteria for the statement of the
percentage of an ingredient in a drug
(§201.10(d)(2));
•
Declaration that an ingredient is a
derivative or a preparation of a
substance specifically named in section
502(e) of the FFD&C Act when the
established name does not indicate such
(§201.10(f));
•
Criteria for the frequency of use and
use in the running text of the
established name in association with the
proprietary name or designation for the
drug or any ingredient thereof in the
label or labeling of a prescription drug
(§201.10(g)(1));
•
The placement of the quantitative
ingredient information when the
established name does not correspond
to the proprietary name or designation
and the prescription drug contains two
or more active ingredients
(§201.10(h)(1));
•
The location of the expiration date
(§201.17);
•
The information provided by the lot
number (§201.18);
•
Use of the term ‘‘infant’’ (§201.19);
•
Declaration of the presence of FD&C
Yellow No. 5 and FD&C Yellow No. 6
in certain drugs for human use
(§201.20);
•
Declaration of the presence of
phenylalanine as a component of
aspartame in over-the-counter and
prescription drugs for human use
(§201.21);
•
Required warning statements for
prescription drugs containing sulfites
(§201.22);
•
Labeling statements for systemic
antibacterial drug products (§201.24);
and
•
The prescribed statement for
investigational new drugs limiting them
to investigational use (§312.6(a)).
2. Biological Drug Products (§610.68(f))
In addition to the labeling
requirements for investigational new
drugs in §312.6, certain labeling
requirements for biological products in
21 CFR part 610 subpart G, except to the
extent that they are explicitly required
by statute, may also be the subject of an
exception or alternative under this rule:
•
The information required on the
product’s container label (§610.60);