Document ID: FDA-2007-0650-0001
Agency: fda
Document Type: Rule
Title: Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
Posted Date: 2012-02-06T05:00Z

[Federal Register: December 28, 2007 (Volume 72, Number 248)]
[Rules and Regulations]               
[Page 73589-73602]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28de07-9]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 312, 314, 601, 610, 801, 807, 809, 812, and 814

[Docket No. 2006N-0466]

 
Exceptions or Alternatives to Labeling Requirements for Products 
Held by the Strategic National Stockpile

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is issuing regulations 
to permit FDA Center Directors to grant exceptions or alternatives to 
certain regulatory labeling requirements applicable to human drugs, 
biological products, or

[[Page 73590]]

medical devices that are or will be included in the Strategic National 
Stockpile (SNS). Under this rule, the appropriate FDA Center Director 
may grant an exception or alternative to such labeling requirements if 
he or she determines that compliance with the requirements could 
adversely affect the safety, effectiveness, or availability of 
specified lots, batches, or other units of human drugs, biological 
products, or medical devices that are or will be included in the SNS, 
including not only those that are approved, licensed, or cleared for 
marketing, but also those that are investigational. A grant of an 
exception or alternative under these regulations will include any 
safeguards or conditions deemed appropriate by the FDA Center Director 
to ensure that the labeling of such products includes information for 
the safe and effective use of the products given their anticipated 
circumstances of use. This rule will facilitate the safety, 
effectiveness, and availability of appropriate medical countermeasures 
in the event of a public health emergency.

DATES: The interim final rule is effective on December 28, 2007. Submit 
written or electronic comments on the interim final rule by March 27, 
2008. Submit written or electronic comments regarding the information 
collection by January 28, 2008 to the Office of Management and Budget 
(OMB) (see ADDRESSES).

ADDRESSES: You may submit comments, identified by Docket No. 2006N-
0466, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting comments on the agency Web site.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described in the 
Electronic Submissions portion of this paragraph.
    Instructions: All submissions received must include the agency name 
and docket number for this rulemaking. All comments received may be 
posted without change to http://www.fda.gov/ohrms/dockets/default.htm, 

including any personal information provided. For additional information 
on submitting comments, see the ``Request for Comments'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm 

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 Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.
    Information Collection Provisions: Submit written comments on the 
information collection provisions to the Office of Information and 
Regulatory Affairs, Office of Management and Budget (OMB). To ensure 
that comments on the information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: For information concerning human 
biological products: Stephen Ripley, Center for Biologics Evaluation 
and Research (HFM-17), Food and Drug Administration, 1401 Rockville 
Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.
    For information concerning human drug products: Brad G. Leissa, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
Mail Stop 1603, 10903 New Hampshire Ave., White Oak Complex, Building 
21, Room 1624, Silver Spring, MD 20993, 301-796-2190.
    For information concerning medical devices: Casper E. Uldriks, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 2094 Gaither Rd., rm. 229, Rockville, MD 20850, 301-
276-0106.

SUPPLEMENTARY INFORMATION:

I. Introduction

    This interim final rule applies to human drugs, biological 
products, and medical devices (hereinafter referred to collectively as 
medical products) that are or will be held in the SNS, including those 
SNS assets that are held at the manufacturer's facility or elsewhere on 
behalf of the SNS (e.g., vendor managed inventory that is distributed, 
held, and managed by manufacturers or commercial distributors for the 
SNS) and prepositioned locations (e.g., CHEMPACKs that are distributed, 
held, and managed by hospitals and other facilities for the SNS).
    An act of terrorism or a natural disaster event may result in the 
need for rapid access to large quantities of medical products. Under 
the Public Health Service Act (PHS Act), the Department of Health and 
Human Services (HHS) stockpiles medical products that are essential to 
the health security of the Nation. (See PHS Act section 319F-2, 42 
U.S.C. 247d-6b)). This collection of medical products , known as the 
SNS, is to ``provide for the emergency health security of the United 
States, including the emergency health security of children and other 
vulnerable populations, in the event of a bioterrorist attack or other 
public health emergency.'' The SNS is maintained by the Assistant 
Secretary for Preparedness and Response (ASPR), exercising this 
responsibility and authority of the Secretary, in collaboration with 
the Director of the Centers for Disease Control and Prevention (CDC), 
and in coordination with the Department of Homeland Security. Examples 
of situations that may necessitate the deployment of such products from 
the SNS are:
     Acts of terrorism using chemical, biological, 
radiological, or nuclear agents;
     Mass trauma; or
     Natural disasters such as hurricanes, pandemics, or 
earthquakes.
    The SNS is also designed to augment similar stockpiles of medical 
supplies held by State and local public health agencies for use in the 
event of a national emergency.

II. Background

    It may be appropriate for certain medical products that are or will 
be held in the SNS to be labeled in a manner that would not comply with 
certain FDA labeling regulations, given their anticipated circumstances 
of use in an emergency. However, noncompliance with these labeling 
requirements could render such products misbranded under section 502 of 
the Federal Food, Drug, and Cosmetic Act (the FFD&C Act or the act) (21 
U.S.C. 352).
    Under this rule, the appropriate FDA Center Director may grant an 
exception or alternative to certain FDA labeling requirements if 
compliance with the requirements could adversely affect the safety, 
effectiveness, or availability of products that are or will be in the 
SNS. An exception or alternative granted

[[Page 73591]]

under this rule may include conditions or safeguards so that the 
labeling for such products includes appropriate information necessary 
for the safe and effective use of the product given the product's 
anticipated circumstances of use.
    Issues relating to the labeling of products that are or will be in 
the SNS exist now and will likely continue to develop. Such labeling 
issues may arise as a result of many different factors, including the 
indicated use, the storage location, the necessary storage conditions 
for a particular product, or the unique distribution mechanisms that 
may be used in an emergency. The provisions of this rule apply only to 
medical products that are or will be included in the SNS.
    The medical products that may be stockpiled in the SNS include not 
only those that are approved, licensed, or cleared for marketing, but 
also those that are investigational.\1\ When HHS procures 
investigational medical products for the SNS (i.e., products for which 
investigational new drug (IND) applications or investigational device 
exemptions (IDE) are in effect), it anticipates that these products may 
eventually become licensed, approved, or cleared for marketing by FDA 
while the products remain stockpiled. Labels on investigational 
products, however, including those in the SNS, ordinarily would not 
contain all elements required on licensed, approved, or cleared product 
labels.
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    \1\Medical products stockpiled in the SNS may also include 
products that will ultimately be used in an emergency under section 
564 of the FFD&C act (21 U.S.C. 360bbb-3) (regarding Emergency Use 
Authorizations).
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    For example, certain information may not be available until after 
approval of the product. For licensed biological products, Sec.  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, Sec.  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, Sec.  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 (Sec.  
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 Sec.  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 Sec. Sec.  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 Sec.  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

[[Page 73592]]

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 Sec.  314.70 (21 CFR 314.70) (human drugs), Sec.  
601.12 (21 CFR 601.12) (biological drugs), Sec.  814.39 (21 CFR 814.39) 
(medical devices subject to premarket approval), or Sec.  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 Sec.  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 Sec.  807.81(a)(3).

E. Labeling Provisions Subject to Exception or Alternative

    We are listing in Sec. Sec.  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

[[Page 73593]]

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 (Sec.  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 Sec.  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 (Sec.  201.1(h)(1));
     Appearance of a person's name without qualification on the 
label (Sec.  201.1(h)(2));
     Appropriate qualifying phrases for the identity of the 
distributor or packer (Sec.  201.1(h)(5) and (h)(6));
     Criteria for the statement of the place of business (Sec.  
201.1(i));
     Placement of the ingredient information required by 
section 502(e) of the FFD&C Act (Sec.  201.10(a));
     Criteria for the statement of the percentage of an 
ingredient in a drug (Sec.  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 (Sec.  
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 (Sec.  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 (Sec.  201.10(h)(1));
     The location of the expiration date (Sec.  201.17);
     The information provided by the lot number (Sec.  201.18);
     Use of the term ``infant'' (Sec.  201.19);
     Declaration of the presence of FD&C Yellow No. 5 and FD&C 
Yellow No. 6 in certain drugs for human use (Sec.  201.20);
     Declaration of the presence of phenylalanine as a 
component of aspartame in over-the-counter and prescription drugs for 
human use (Sec.  201.21);
     Required warning statements for prescription drugs 
containing sulfites (Sec.  201.22);
     Labeling statements for systemic antibacterial drug 
products (Sec.  201.24); and
     The prescribed statement for investigational new drugs 
limiting them to investigational use (Sec.  312.6(a)).
2. Biological Drug Products (Sec.  610.68(f))
    In addition to the labeling requirements for investigational new 
drugs in Sec.  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 
(Sec.  610.60);\2\
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    \2\This is distinct from the requirements for a product's 
package label under Sec.  610.61 (21 CFR 610.61).
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     Certain information on the package label, specifically: 
Lot number, information on the preservative, number of containers, 
recommended storage temperature, certain instructions for use, 
recommended individual dose, route of administration, known sensitizing 
substances, type and amount of added antibiotics, inactive ingredients, 
adjuvant, source of product, identity of microorganisms used in 
manufacture, and minimum potency (Sec.  610.61(c) and (e) through (r));
     Requirements relating to the position and prominence of 
the proper name on the package label as well as requirements relating 
to size and type of characters (21 CFR 610.62);
     The placement on the container and package label of the 
name, address, and license information of each manufacturer 
participating in the manufacture of a biological product, if two or 
more manufacturers participate in manufacturing (21 CFR 610.63);
     The name and address of the distributor, and the required 
identifying phrases on the label (21 CFR 610.64); and
     Label requirements relating to products for export (21 CFR 
610.65)
3. Medical Devices (Sec.  801.128(f))
    For medical devices, the appropriate FDA Center Director may grant 
a request for an exception or alternative to certain labeling 
requirements in parts 801 and 812 (21 CFR parts 801 and 812), except to 
the extent that they are explicitly required by statute:
     Criteria for the statement of the place of business (Sec.  
801.1(d));
     Labeling information on the principal display panel of 
over-the-counter devices in package form, i.e., the part of a label 
that is most likely to be displayed, presented, shown, or examined 
under customary conditions of display for retail sale (Sec.  801.60);
     Requirements related to an accurate statement of principal 
intended action and format of a statement of identity for an over-the-
counter device in package form (Sec.  801.61);
     Requirements related to the declaration of net quantity of 
contents on the label of an over-the-counter device in package form 
(Sec.  801.62);
     Warning statement for over-the-counter devices containing 
or manufactured with chlorofluorocarbons and other class I ozone-
depleting substances (Sec.  801.63);
     Labeling requirements for prescription devices (Sec.  
801.109);
     Labeling requirements for specific devices including 
dentures and hearing aids (part 801, subpart H);
     The prescribed statement for investigational devices 
limiting the device to investigational use (Sec.  812.5(a)); and
     The prescribed statement for investigational devices used 
solely on research animals limiting the device to investigational use 
in laboratory animals (Sec.  812.5(c)).
4. In Vitro Diagnostic Products (Sec.  809.11(f))
    The appropriate FDA Center Director may grant a request for an 
exception or alternative to the following requirements pertaining to 
IVDs in parts 809 (21 CFR part 809) and 812, except to the extent that 
they are explicitly required by statute.
     Certain label information for IVDs, i.e., the proprietary 
name; the intended use or uses of the product; for a reagent, the 
declaration of the established name, if any, the quantity, proportion, 
and concentration of each reactive ingredient, and the source and 
activity if derived from a biological material; statement of warnings 
or precautions; for a reagent, appropriate storage instructions 
adequate to protect the stability of the product; for a reagent, a 
means by which the user may be ensured that the product meets 
appropriate standards of identity, strength, quality and purity at the 
time of use; and a lot or control number (Sec.  809.10(a)(1) through 
(a)(6) and (a)(9));

[[Page 73594]]

     Labeling accompanying each IVD, including reagents and 
instruments, i.e., such information as proprietary name, intended use 
or uses, summary and explanation of the test, a statement of warnings 
or precautions for users, information regarding specimen collection and 
preparation for analysis, outline of recommended procedures, 
information regarding results, limitation of the procedure, expected 
values, specific performance characteristics, and bibliography (Sec.  
809.10(b));
     The prescribed statements for investigational IVDs that 
are not subject to part 812 (Sec.  809.10(c)(2));
     The label of general purpose laboratory reagents, i.e., 
the proprietary name; the quantity, proportion, or concentration of the 
reagent ingredient; and for a reagent derived from biological material, 
the source and measure of activity; statement of purity and quality of 
the reagent; statement of warnings or precautions; appropriate storage 
instructions adequate to protect the stability of the product; and a 
lot or control number (Sec.  809.10(d)(1)(i) through (d)(1)(v) and 
(d)(1)(viii));
     Labeling of general purpose laboratory equipment, i.e., 
description of the product, its composition, and physical 
characteristics if necessary for use (Sec.  809.10(d)(2)); and
     Labeling for analyte specific reagents, i.e., the 
proprietary name; the quantity, proportion, or concentration of the 
reagent ingredient; and for a reagent derived from biological material, 
the source and measure of activity; statement of purity and quality of 
the reagent; statement of warnings or precautions for users; date of 
manufacture and appropriate storage instructions adequate to protect 
the stability of the product; a lot or control number; prescribed 
statements regarding analytical and performance characteristics 
specific to class I, II, and III analyte specific reagents (Sec.  
809.10(e)(1)(i) through (e)(1)(vi) and (e)(1)(ix) through (e)(1)(xi)).

IV. Legal Authority

    In this interim final rule, FDA is amending regulations pertaining 
to the content and format of medical product labeling. The provisions 
of this rule will allow FDA to grant exceptions or alternatives to 
certain of those labeling requirements. The labeling regulations to 
which exceptions or alternatives will be permitted were issued by FDA 
under authority of the FFD&C Act and the PHS Act to mandate particular 
ways that firms must satisfy the broad requirements and prohibitions in 
those statutes, such as the prohibition on false and misleading drug 
and device labeling. As described in section II of this document, FDA 
has determined that circumstances may arise in which compliance with 
those regulatory mandates could adversely affect the safety, 
effectiveness, or availability of certain medical products that are or 
will be included in the SNS. Moreover, due to the unique nature of the 
SNS, those products could deviate from particular mandates of existing 
labeling regulations without violating the broad statutory requirements 
and prohibitions in the FFD&C Act and the PHS Act. For those reasons, 
FDA is exercising its authority to regulate labeling by modifying the 
existing regulations in a way that will allow exceptions or 
alternatives for medical products that are or will be included in the 
SNS.
    FDA has various sources of authority to issue labeling regulations. 
For example, under section 502(a) of the FFD&C Act, a drug (including 
biological products) or device is misbranded if its labeling is false 
or misleading in any particular. In determining whether a product's 
labeling is misleading, FDA may consider not only representations or 
suggestions made in the labeling, but also whether the labeling fails 
to reveal material facts in light of those representations or 
suggestions or with respect to consequences which may result from the 
use of the product under customary or usual conditions of use (section 
201(n) of the FFD&C Act (21 U.S.C. 321(n))). By authority delegated 
under section 701(a) of the FFD&C Act (21 U.S.C. 371(a)), FDA is 
authorized to issue regulations for the efficient enforcement of the 
FFD&C Act. Existing FDA regulations mandating specific labeling content 
and format for drugs and devices satisfy those general statutory 
standards. For example, many labeling regulations are designed to 
ensure that nothing in the labeling is false or misleading in any 
particular, to ensure that the labeling reveals all material facts in 
light of the representations or suggestions in the labeling, and to 
ensure that FDA may efficiently enforce those statutory requirements as 
well as other requirements of the FFD&C Act and the PHS Act.
    Because biological products are also drugs as defined within the 
FFD&C Act, the authority discussed previously extends to regulations 
prescribing content and format requirements for biological product 
labeling. There is, however, additional legal authority in the PHS Act 
for this rule's requirements with respect to biological products 
generally. For example, section 351(a)(1)(A) of the PHS Act provides 
that no person may introduce or deliver for introduction into 
interstate commerce any biological product unless a biologics license 
is in effect for the product. By authority delegated under section 
351(a)(2)(A) of the PHS Act, FDA is required to establish, by 
regulation, requirements for the approval, suspension, and revocation 
of biologics licenses.
    Because the SNS is intended ``to provide for the emergency health 
security of the United States * * * in the event of a bioterrorist 
attack or other public health emergency,''\3\ the SNS may contain 
products that would otherwise not be available for widespread 
distribution. For example, the ASPR (exercising the Secretary's 
authority), in collaboration with the Director of the CDC and in 
coordination with the Department of Homeland Security, may determine 
that it is appropriate to include certain investigational medical 
products in the SNS. As described in section II of this document, some 
of these products require storage at extremely low temperatures and 
cannot be temporarily removed from storage for relabeling without 
compromising their integrity. Moreover, shipping products from SNS 
storage sites to relabelers or back to manufacturers for relabeling 
could increase the potential for sabotage and diversion, as well as 
increase exposure to conditions affecting product quality, such as 
temperature deviations. As a result, removing these investigational 
products from storage for relabeling at the time of approval and then 
returning them to storage could undermine their safety, effectiveness, 
or availability and, in some cases, would be impracticable. Compliance 
with the FDA regulations that would require such relabeling could 
discourage SNS procurement of these products and thereby limit 
available countermeasures in the event of a bioterrorist attack or 
other public health emergency.
---------------------------------------------------------------------------

    \3\Section 3 of the Project BioShield Act of 2004 (section 319F-
2 of the PHS Act (42 U.S.C. 247d-6b)).
---------------------------------------------------------------------------

    To address this concern, FDA is creating a mechanism to allow 
exceptions or alternatives to the labeling regulations specified in 
this rule to help ensure the safety, effectiveness, and availability of 
medical products that are or will be included in the SNS. FDA has 
concluded that exceptions or alternatives granted under this rule will 
not render products misbranded due to the additional safeguards and 
conditions that may be required when an exception or alternative is 
granted, as well as the unique storage, deployment, and distribution 
considerations

[[Page 73595]]

essential to the SNS. As explained in section III.D of this document, a 
grant of an exception or alternative under this rule may include 
additional safeguards or conditions so that the labeling of products 
subject to the exception or alternative includes information needed for 
safe and effective use under the anticipated circumstances of use. 
Moreover, products intended for use in certain public health 
emergencies are likely to be administered to large numbers of people 
within confined geographic areas, such as in the case of a natural 
disaster. These SNS products may therefore be packaged in large 
quantities to facilitate rapid distribution on extremely short notice. 
Consequently, their packaging and distribution may differ from that of 
non-SNS products. Moreover, HHS may establish special mechanisms to 
provide product information, collect adverse event information, and 
track the product's distribution.
    This rule does not create exemptions from express statutory 
requirements or prohibitions regarding medical product labeling. The 
FFD&C Act and the PHS Act set forth certain types of information that 
must appear in the labeling for medical products. For example, section 
351(a)(1)(B) of the PHS Act provides that each package of a biological 
product must be marked with the proper name of the biological product; 
the name, address, and applicable license number of the manufacturer of 
the biological product; and the expiration date of the biological 
product. Drugs (including biological products) and medical devices in 
package form must bear labels containing the name and place of business 
of the manufacturer, packer, or distributor (section 502(b)(1) of the 
FFD&C Act). This interim final rule does not permit exceptions or 
alternatives to any of those requirements. In addition, the FFD&C Act 
and the PHS Act both prohibit false labeling (section 502(a) of the 
FFD&C Act); section 351(b) of the PHS Act). This interim final rule 
does not allow false information to appear in medical product labeling.
    As noted previously, this rule does not limit FDA's ability to 
exercise enforcement discretion with respect to statutory and 
regulatory requirements, including those involving medical product 
labeling (see Heckler v. Chaney, 470 U.S. 821 (1985)).
    To the extent that a State requires labeling that directly 
conflicts with, is different from, or is in addition, to any exceptions 
or alternatives granted under this rule, the State-required labeling 
would be subject to implied conflict preemption and, in some cases, 
express preemption. FDA restated its longstanding views on preemption 
in the preamble to the recently promulgated final rule entitled 
``Requirements on Content and Format of Labeling for Human Prescription 
Drug and Biological Products'' (see 71 FR 3922 at 3933 through 3936 and 
3967 through 3969; January 24, 2006), and that discussion reflects the 
agency's current position on this issue.
    Under the principles of implied conflict preemption, courts have 
found State law preempted where it is impossible to comply with both 
Federal and State law or where the State law ``stands as an obstacle to 
the accomplishment and execution of the full purposes and objectives of 
Congress.'' See English v. General Electric Co., 496 U.S. 72, 79 
(1990); Florida Lime & Avocado Growers, Inc., 373 U.S. 132, 142-143 
(1963); Hines v. Davidowitz, 312 U.S. 52, 67 (1941). Consistent with 
this case law, section 4(a) of Executive Order 13132 states that 
``[a]gencies shall construe * * * a Federal statute to preempt State 
law only where the statute contains an express preemption provision or 
there is some other clear evidence that the Congress intended 
preemption of State law, or where the exercise of State authority 
conflicts with the exercise of Federal authority under the Federal 
statute.''
    As explained previously, this interim final rule will facilitate 
the safety, effectiveness, and availability of appropriate medical 
countermeasures in the event of a public health emergency. Because 
Congress authorized the SNS to ``provide for the emergency health 
security of the United States * * * in the event of a bioterrorist 
attack or other public health emergency,'' products held in the SNS 
should be ready for deployment at all times. In an emergency, it is 
critical that State requirements regarding the content and format of 
labeling do not interfere with the safety, effectiveness, or 
availability of SNS products. FDA believes that State-required labeling 
requirements different from or in addition to FDA requirements would 
``stand as an obstacle to the accomplishment and execution of the full 
purposes and objectives of Congress.'' See Hines, 312 U.S. at 67. 
Moreover, these State requirements would ``conflict with the exercise 
of Federal authority under [PHS Act section 319F-2, 42 U.S.C. 247d-
6b].'' See Executive Order 13132.
    Additionally, under section 751 of the FFD&C Act (21 U.S.C. 379r), 
State or local requirements that are different from or in addition to 
exceptions or alternatives granted under this rule, and relate to the 
regulation of nonprescription drugs, are expressly preempted. 
Similarly, in accordance with section 521 of the FFD&C Act (21 U.S.C. 
360k), State or local requirements that are different from, or in 
addition to, exceptions or alternatives granted under this rule with 
respect to approved medical devices are expressly preempted. See the 
Federalism section in this document for additional discussion of 
preemption in the context of this interim final rule.

V. Issuance of an Interim Final Rule, Immediate Effective Date, and 
Opportunity for Public Comment

    FDA is issuing this rule as an interim final rule, effective 
immediately, with an opportunity for public comment. Section 
553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 
553(b)(3)(B)) provides that, when an agency for good cause finds that 
notice and public procedure are impracticable, unnecessary, or contrary 
to public interest, the agency may issue a rule without providing 
notice and public comment. FDA has determined that there is good cause 
under 5 U.S.C. 553(b)(3)(B) and 21 CFR 10.40(d) to publish this 
regulation as an interim final rule. An emergency requiring deployment 
of medical products in the SNS could happen at any time. Without this 
rule, the safety, effectiveness, or availability of medical products 
held in the SNS could be adversely affected because of relabeling 
requirements. An interim final rule ensures that a legal mechanism is 
immediately available for addressing labeling issues associated with 
medical products in the SNS without compromising their safety, 
effectiveness, or availability for use in an emergency. Products held 
in the SNS should be ready for deployment at all times.
    FDA invites public comment on this interim final rule. The comment 
period on this interim final rule will be 90 days. The agency will 
consider modifications to this interim final rule based on comments 
made during the comment period. Interested persons may submit to the 
Division of Dockets Management (see ADDRESSES) written or electronic 
comments regarding this interim final rule. Submit a single copy of 
electronic comments or two paper copies of any mailed comments, except 
that individuals may submit one paper copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

[[Page 73596]]

    FDA will address comments received and confirm or amend this 
interim final rule in a final rule.

VI. Analysis of Impacts

    FDA has examined the impacts of the interim final rule under 
Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this interim final rule is not a significant regulatory action under 
the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because of the deregulatory nature of this rule and 
the minimal costs associated with applying for an exception or 
alternative under this rule, the agency certifies that the interim 
final rule will not have a significant economic impact on a substantial 
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $127 million, using the most current (2006) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
interim final rule to result in any 1-year expenditure that would meet 
or exceed this amount.

A. Need for the Interim Final Rule

    FDA is issuing this interim final rule to allow for exceptions or 
alternatives to specified labeling requirements for certain medical 
products that are or will be in the SNS. As explained in other sections 
of this preamble, compliance with these labeling requirements in some 
circumstances could adversely affect or compromise the safety, 
effectiveness or availability of these products. Exceptions or 
alternatives to certain labeling requirements will provide the 
flexibility needed to help ensure that FDA-regulated medical products 
that are or will be in the SNS are not deemed misbranded and are 
available in an emergency situation.

B. Scope of the Interim Final Rule

    This interim final rule applies to medical products that are or 
will be stockpiled by the SNS. It allows entities that manufacture 
(including labeling, packing, relabeling, or repackaging), distribute, 
or store affected SNS products to request an exception or alternative 
to specified regulatory labeling requirements for human drugs, 
biological products, and medical devices to prevent misbranding of 
those products in the SNS. Any grant of such a request by an FDA Center 
Director would apply to specified lots, batches, or other units of 
medical product identified in the request. When reviewing requests, the 
FDA Center Director will consider whether complying with the specified 
labeling regulations could adversely affect the safety, effectiveness, 
or availability of stockpiled products and may impose appropriate 
safeguards and conditions so that the labeling of products subject to 
the request would include information needed for safe and effective use 
under the anticipated circumstances of use. Alternatively, at his or 
her own initiative, an FDA Center Director may grant an exception or 
alternative to the specified labeling provisions without receiving a 
written request. Allowing the agency the ability to act on its own 
initiative could help avoid misbranding of products that are or will be 
in the SNS.

C. Costs of the Interim Final Rule

    This rule would allow SNS officials and entities that manufacture 
(including labeling, packing, relabeling, or repackaging), distribute, 
or store medical products in the SNS to request exceptions from certain 
labeling requirements in FDA regulations. An exception or alternative 
from specified labeling requirements for FDA-regulated medical products 
can also be initiated by the appropriate FDA Center Director. The 
interim final rule would impose compliance costs on industry when 
entities prepare and submit requests for exceptions or alternatives to 
labeling requirements to avoid misbranding of their products that are 
or will be in the SNS. However, granting exceptions or alternatives to 
labeling requirements would provide the government with the flexibility 
needed to more efficiently manage medical products in the SNS without 
risking the availability of medical products for emergency use (see 
section VI.D of this document, Benefits of the Interim Final Rule).
    FDA estimates that requests for exceptions would cost from $380 to 
$1,130 for each request. Regulatory Affairs personnel may spend from 8 
to 24 hours per request preparing the information that would be 
required in an application for an exception or alternative under this 
rule. According to Bureau of Labor Statistics data, the fully loaded 
hourly wage for management and professional employees working in goods-
producing industries was $47.25 in 2004 (U.S. Department of Labor, 
Bureau of Labor Statistics, ``Employer Cost Employee Compensation--
December 2004,'' Bureau of Labor Statistics News, USDL 05-432, March 
16, 2005).

D. Benefits of the Interim Final Rule

    Although the agency has no data to quantify the benefits, this 
interim final rule provides flexibility in labeling requirements for 
FDA-regulated medical products in the SNS. If an exception or 
alternative is granted, affected medical products in the SNS would not 
be misbranded and would not be rendered unavailable for emergency use 
due to relabeling operations. Exceptions or alternatives may be granted 
on a case-by-case basis at the initiative of the appropriate FDA Center 
Director or after receipt of a written request from an entity that 
manufactures, distributes, or stores products in the SNS. To illustrate 
the potential benefits of this rule we describe costs that could be 
avoided by granting an exception or alternative to certain labeling 
requirements upon written request of a manufacturer.
    In some cases, granting an exception to labeling requirements may 
save direct relabeling costs. For example, to change information on a 
carton or container label, a firm might spend $300 in material costs 
for new artwork, $600 to $1,000 in labor costs to prepare the new 
artwork and about 10 cents to print each new carton or container label. 
Besides the costs to prepare a new carton, there would be additional 
labor costs to remove the product from the old carton and insert it in 
the new carton. With a container label, it is likely that the new label 
could be affixed directly on top of the existing label, reducing the 
amount of effort needed to make this change. Because packaging is 
normally automated, the agency has no information about how much time 
it would take to manually replace a container label or exchange a 
carton, but believes this could cost about 5 to 10 cents per unit.
    Before the implementation of this rule, when an investigational 
product in

[[Page 73597]]

the SNS was subsequently approved, the product labeling would have 
needed to be immediately changed to add approved labeling information 
that was unavailable prior to approval. An exception or alternative to 
these labeling requirements might allow entities to ship 
investigational products with labeling that can be manually modified or 
supplemented at the SNS location once the drug is approved. Without an 
exception or alternative, it would be necessary to remove the 
investigational products from the SNS for relabeling or, in some cases, 
to replace the product.
    This rule would avoid other potential costs. Without an exception 
or alternative, the SNS might be required to purchase costly 
replacement units. In other cases, some products may be appropriate for 
exceptions or alternatives because their availability for use in an 
emergency could be compromised if they had to be shipped out of the SNS 
to be relabeled. Removing such products from the stockpile, even 
temporarily, could jeopardize or adversely affect product safety or 
effectiveness (due to conditions of relabeling or related shipping, 
storage, and handling), requiring additional product testing or product 
replacement. Because replacement costs would vary widely and depend on 
the nature of the product, the number of units affected, and current 
market price, the amount of these avoided costs is unknown.
    Although we only describe the potential benefits of this interim 
final rule in qualitative terms, we believe it is reasonable to assume 
that the benefits of providing flexibility in labeling requirements for 
SNS products justify the potential compliance costs of the rule. 
Moreover, the rule will allow FDA the flexibility to manage the 
products in the SNS without risking the safety, effectiveness, or 
availability of these products for use in an emergency.

E. Small Business Impacts

    FDA has examined the economic implications of this proposed rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a 
rule has a significant economic impact on a substantial number of small 
entities, the Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would lessen the economic effect of the rule on 
small entities. This rule is not expected to have a significant impact 
on a substantial number of small entities. It is estimated that this 
interim final rule will cost small entities no more than $1,130 when 
they submit a request. For affected small entities (e.g., medical 
product manufacturers, relabelers, or packers) we expect that this 
would represent a negligible proportion of annual receipts. Therefore, 
the agency certifies that the interim final rule will not have a 
significant economic impact on a substantial number of small entities.

F. Regulatory Options Considered

    No new regulatory action. The agency considered and rejected this 
option. The Agency recognized that certain medical products in the SNS, 
due to their anticipated circumstances of use in an emergency, might 
need to be labeled in a manner that did not comply with certain FDA 
labeling regulations. Without the ability to grant an exception to 
labeling requirements, existing FDA labeling regulations would have 
rendered such medical products misbranded. Moreover, the relabeling of 
these products to comply with FDA labeling regulations could have 
adversely affected their safety, effectiveness, or availability. As a 
result, FDA would have needed to exercise enforcement discretion to 
allow labeling to deviate from FDA requirements. To the extent 
possible, FDA believes that amending its labeling regulations is 
preferable to reliance on enforcement discretion to ensure the 
continued availability of medical products that are or will be in the 
SNS.

VII. The Paperwork Reduction Act of 1995

    This interim final rule contains information collection provisions 
that are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The title, description, and respondent description of the 
information collection provisions are shown as follows with an estimate 
of the annual reporting burden. Included in the estimate is the time 
for reviewing instructions, searching existing data sources, gathering 
and maintaining the data needed, and completing and reviewing each 
collection of information.
    FDA invites comments on the following topics: (1) Whether the 
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 
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.
    Title: Exceptions or Alternatives to Labeling Requirements for 
Products Held by the Strategic National Stockpile.
    Description: FDA is issuing regulations to permit FDA Center 
Directors to grant a request submitted under Sec. Sec.  201.26(c)(1)(i) 
(human drug products), 610.68(c)(1)(i) (biological products), 
801.128(c)(1)(i) (medical devices), and 809.11(c)(1)(i) (in vitro 
diagnostic products for human use) for an exception or alternative to 
certain applicable regulatory labeling provisions when these products 
are or will be included in the SNS.
    The request must:
     Identify the specified lots, batches, or other units of 
the affected product;
     Identify the labeling provisions under this rule that are 
the subject of the request;
     Explain why compliance with the specified labeling 
provisions could adversely affect the safety, effectiveness, or 
availability of the product subject to the request;
     Describe any proposed safeguards or conditions that will 
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 of the product;
     Provide a draft of the proposed labeling; and
     Provide any other information requested by the FDA Center 
Director in support of the request.
    The FDA Center Director will grant the request if he or she 
determines that compliance with the identified labeling provisions 
could adversely affect the safety, effectiveness, or availability of 
specified lots, batches, or other units of human drugs, biological 
products, or medical devices that are or will be included in the SNS.
    Description of Respondents: Entities that manufacture (including 
labeling, packing, relabeling, or repackaging), distribute, or store 
affected products.
    FDA estimates the information collection burden as follows:

[[Page 73598]]

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
201.26(c)(1)(i)                                                        18                     1                 18                 24                432
--------------------------------------------------------------------------------------------------------------------------------------------------------
610.68(c)(1)(i)                                                        10                     1                 10                 24                240
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.128(c)(1)(i) and 809.11(c)(1)(i)                                    2                     1                  2                 24                 48
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                                720
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Although FDA cannot predict the number of future requests, based on 
limited information within FDA, we estimate that approximately 30 
respondents will request annually one exception or alternative to 
labeling provisions to avoid misbranding of their products in the SNS. 
The estimate of one request per respondent is based on the anticipated 
occasional occurrence of a product being misbranded while in the SNS. 
We are estimating that each respondent will spend from 8 to 24 hours 
preparing each request. The hours per response are based on estimated 
time that it takes to prepare a supplement to an application, which may 
be considered similar to a request for an exception or alternative.
    The information collection provisions in Sec. Sec.  314.70, 601.12, 
807.81 and 814.39 have been approved under OMB control numbers 0910-
0001 (expires May 31, 2008), 0910-0338 (expires September 30, 2008), 
0910-0120 (expires August 31, 2010), and 0910-0231 (expires September 
30, 2007), respectively.
    The information collection provisions for this interim final rule 
have been approved under the emergency processing provisions of the 
PRA. The assigned OMB approval number of this collection of information 
is 0910-0614. This approval expires on June 30, 2008. Interested 
persons are requested to fax comments regarding the information 
collection by (see DATES) to the Office of Information and Regulatory 
Affairs, OMB (see ADDRESSES).
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number.

VIII. Environmental Impact

    The agency has determined under 21 CFR 25.30(k) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IX. Federalism

    As stated in the preamble, FDA has analyzed this interim final rule 
in accordance with the principles set forth in Executive Order 13132. 
Section 4(a) of this Executive Order requires agencies to ``construe * 
* * a Federal statute to preempt State law only where the statute 
contains an express preemption provision or there is some other clear 
evidence that the Congress intended preemption of State law, or where 
the exercise of State authority conflicts with the exercise of Federal 
authority under the Federal statute.'' In this rule, FDA is revising 
certain requirements concerning the format and content of labeling for 
human drugs, biological products, and medical devices that are or will 
be included in the SNS to provide for exceptions or alternatives to 
these requirements under specified circumstances. To the extent that a 
State requires labeling that directly conflicts with, is different 
from, or is in addition, to any exceptions or alternatives granted 
under this rule, the State-required labeling would be subject to 
implied conflict preemption. Moreover, certain State requirements 
regarding the format and content of nonprescription drug labeling and/
or labeling of approved medical devices may be subject to the express 
preemption provisions in section 751 of the FFD&C Act (21 U.S.C. 360k) 
(nonprescription drugs) and section 521 of the FFD&C Act (approved 
medical devices).
    FDA is aware that State requirements on medical product labeling, 
often as a result of product liability lawsuits, may conflict with 
Federal requirements. FDA restated its longstanding views on preemption 
in the preamble to the recently promulgated final rule entitled 
``Requirements on Content and Format of Labeling for Human Prescription 
Drug and Biological Products'' (see 71 FR 3922 at 3933 through 3936 and 
3967 through 3969). That discussion is applicable to this interim final 
rule as well, and reflects the agency's current position on this issue.
    Section 4(c) of Executive Order 13132 instructs us to restrict any 
Federal preemption of State law to the ``minimum level necessary to 
achieve the objectives of the statute pursuant to which the regulations 
are promulgated.'' This interim final rule meets the preceding 
requirement because, as discussed previously, it would preempt only 
State laws that directly conflict with, are different from, or are in 
addition to any Federal requirements. Section 4(d) of Executive Order 
13132 states that when an agency foresees the possibility of a conflict 
between State law and federally protected interests within the agency's 
area of regulatory responsibility, the agency ``shall consult, to the 
extent practicable, with appropriate State and local officials in an 
effort to avoid such a conflict.'' In this case, FDA foresees the 
possibility of a conflict between State law and federally protected 
interests within the agency's area of regulatory responsibility.
    Section 4(e) of Executive Order 13132 adds that ``when an agency 
proposes to act through adjudication or rulemaking to preempt State 
law, the agency ``shall provide all affected State and local officials 
notice and an opportunity for appropriate participation in the 
proceedings.'' FDA is seeking input from all stakeholders on the 
provisions of this interim final rule through publication of the rule 
in the Federal Register, and will consult with State and local 
officials in an effort to avoid conflicts between State law and Federal 
protected interests in accordance with Executive Order 13132.
    In conclusion, the agency believes that it has complied with all of 
the applicable requirements under Executive Order 13132 and has 
determined that this interim final rule is consistent with the 
Executive order.

X. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see

[[Page 73599]]

ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

List of Subjects

21 CFR Part 201

    Drugs, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 312

    Drugs, Exports, Imports, Investigations, Labeling, Medical 
research, Reporting and recordkeeping requirements, Safety.

21 CFR Part 314

    Administrative practice and procedure, Confidential business 
information, Drugs, Reporting and recordkeeping requirements.

21 CFR Part 601

    Administrative practice and procedure, Biologics, Confidential 
business information.

21 CFR Part 610

    Biologics, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 801

    Labeling, Medical devices, Reporting and recordkeeping 
requirements.

21 CFR Part 807

    Confidential business information, Imports, Medical devices, 
Reporting and recordkeeping requirements.

21 CFR Part 809

    Labeling, Medical devices.

21 CFR Part 812

    Health records, Medical devices, Medical research, Reporting and 
recordkeeping requirements.

21 CFR Part 814

    Administrative practice and procedure, Confidential business 
information, Medical devices, Medical research, Reporting and 
recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and the 
Public Health Service Act, and under authority delegated to the 
Commissioner of Food and Drugs, 21 CFR chapter I is amended as follows:

PART 201--LABELING

0
1. The authority citation for 21 CFR part 201 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360, 
360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.

0
2. Add Sec.  201.26 to subpart A to read as follows:

Sec.  201.26  Exceptions or alternatives to labeling requirements for 
human drug products held by the Strategic National Stockpile.

    (a) The appropriate FDA Center Director may grant an exception or 
alternative to any provision listed in paragraph (f) of this section 
and not explicitly required by statute, for specified lots, batches, or 
other units of a human drug product, if the Center Director determines 
that compliance with such labeling requirement could adversely affect 
the safety, effectiveness, or availability of such product that is or 
will be included in the Strategic National Stockpile.
    (b)(1)(i) A Strategic National Stockpile official or any entity 
that manufactures (including labeling, packing, relabeling, or 
repackaging), distributes, or stores a human drug product that is or 
will be included in the Strategic National Stockpile may submit, with 
written concurrence from a Strategic National Stockpile official, a 
written request for an exception or alternative described in paragraph 
(a) of this section to the Center Director.
    (ii) The Center Director may grant an exception or alternative 
described in paragraph (a) of this section on his or her own 
initiative.
    (2) A written request for an exception or alternative described in 
paragraph (a) of this section must:
    (i) Identify the specified lots, batches, or other units of the 
human drug product that would be subject to the exception or 
alternative;
    (ii) Identify the labeling provision(s) listed in paragraph (f) of 
this section that are the subject of the exception or alternative 
request;
    (iii) Explain why compliance with such labeling provision(s) could 
adversely affect the safety, effectiveness, or availability of the 
specified lots, batches, or other units of a human drug product that 
are or will be held in the Strategic National Stockpile;
    (iv) Describe any proposed safeguards or conditions that will 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 of the product;
    (v) Provide a draft of the proposed labeling of the specified lots, 
batches, or other units of the human drug product subject to the 
exception or alternative; and
    (vi) Provide any other information requested by the Center Director 
in support of the request.
    (c) The Center Director must respond in writing to all requests 
under this section.
    (d) A grant of an exception or alternative under this section will 
include any safeguards or conditions deemed appropriate by the Center 
Director so that the labeling of product subject to the exception or 
alternative includes the information necessary for the safe and 
effective use of the product, given the anticipated circumstances of 
use.
    (e) If you are a sponsor receiving a grant of a request for an 
exception or alternative to the labeling requirements under this 
section:
    (1) You need not submit a supplement under Sec.  314.70(a) through 
(c) or Sec.  601.12(f)(1) through (f)(2) of this chapter; however,
    (2) You must report any grant of a request for an exception or 
alternative under this section as part of your annual report under 
Sec. Sec.  314.70(d) or 601.12(f)(3) of this chapter.
    (f) The Center Director may grant an exception or alternative under 
this section to the following provisions of this chapter, to the extent 
that the requirements in these provisions are not explicitly required 
by statute:
    (1) Sec.  201.1(h)(1) through (h)(2), (h)(5) through (h)(6), and 
(i);
    (2) Sec.  201.10(a), (d)(2), (f), (g)(1), and (h)(1);
    (3) Sec.  201.17;
    (4) Sec.  201.18;
    (5) Sec.  201.19;
    (6) Sec.  201.20;
    (7) Sec.  201.21;
    (8) Sec.  201.22;
    (9) Sec.  201.24; and
    (10) Sec.  312.6.

PART 312--INVESTIGATIONAL NEW DRUG APPLICATION

0
3. The authority citation for 21 CFR part 312 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 371, 
381, 382, 383, 393; 42 U.S.C. 262.

0
4. Section 312.6 is amended by adding paragraph (c) to read as follows:

Sec.  312.6  Labeling of an investigational new drug.

* * * * *
    (c) The appropriate FDA Center Director, according to the 
procedures set

[[Page 73600]]

forth in Sec. Sec.  201.26 or 610.68 of this chapter, may grant an 
exception or alternative to the provision in paragraph (a) of this 
section, to the extent that this provision is not explicitly required 
by statute, for specified lots, batches, or other units of a human drug 
product that is or will be included in the Strategic National 
Stockpile.

PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

0
5. The authority citation for 21 CFR part 314 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 356, 
356a, 356b, 356c, 371, 374, 379e.

0
6. Section 314.70 is amended by revising paragraph (a)(1) to read as 
follows:

Sec.  314.70  Supplements and other changes to an approved application.

    (a) * * *
    (1)(i) Except as provided in paragraph (a)(1)(ii) of this section, 
the applicant must notify FDA about each change in each condition 
established in an approved application beyond the variations already 
provided for in the application. The notice is required to describe the 
change fully. Depending on the type of change, the applicant must 
notify FDA about the change in a supplement under paragraph (b) or (c) 
of this section or by inclusion of the information in the annual report 
to the application under paragraph (d) of this section.
    (ii) The submission and grant of a written request for an exception 
or alternative under Sec.  201.26 of this chapter satisfies the 
applicable requirements in paragraphs (a) through (c) of this section. 
However, any grant of a request for an exception or alternative under 
Sec.  201.26 of this chapter must be reported as part of the annual 
report to the application under paragraph (d) of this section.
* * * * *

PART 601--LICENSING

0
7. The authority citation for 21 CFR part 601 continues to read as 
follows:

    Authority: 15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353, 
355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C. 
216, 241, 262, 263, 264; sec 122, Pub. L. 105-115, 111 Stat. 2322 
(21 U.S.C. 355 note).

0
8. Section 601.12 is amended by revising paragraph (f)(3)(i)(D) and by 
adding paragraph (f)(5) to read as follows:

Sec.  601.12  Changes to an approved application.

* * * * *
    (f) * * *
    (3)(i) * * *
    (D) A change made pursuant to an exception or alternative granted 
under Sec.  201.26 or Sec.  610.68 of this chapter.
* * * * *
    (5) The submission and grant of a written request for an exception 
or alternative under Sec.  201.26 or Sec.  610.68 of this chapter 
satisfies the requirements in paragraphs (f)(1) through (f)(2) of this 
section.
* * * * *

PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS

0
9. The authority citation for 21 CFR part 610 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 
360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 
264.

0
10. Add Sec.  610.68 to subpart G to read as follows:

Sec.  610.68  Exceptions or alternatives to labeling requirements for 
biological products held by the Strategic National Stockpile.

    (a) The appropriate FDA Center Director may grant an exception or 
alternative to any provision listed in paragraph (f) of this section 
and not explicitly required by statute, for specified lots, batches, or 
other units of a biological product, if the Center Director determines 
that compliance with such labeling requirement could adversely affect 
the safety, effectiveness, or availability of such product that is or 
will be included in the Strategic National Stockpile.
    (b)(1)(i) A Strategic National Stockpile official or any entity 
that manufactures (including labeling, packing, relabeling, or 
repackaging), distributes, or stores a biological product that is or 
will be included in the Strategic National Stockpile may submit, with 
written concurrence from a Strategic National Stockpile official, a 
written request for an exception or alternative described in paragraph 
(a) of this section to the Center Director.
    (ii) The Center Director may grant an exception or alternative 
described in paragraph (a) of this section on his or her own 
initiative.
    (2) A written request for an exception or alternative described in 
paragraph (a) of this section must:
    (i) Identify the specified lots, batches, or other units of the 
biological product that would be subject to the exception or 
alternative;
    (ii) Identify the labeling provision(s) listed in paragraph (f) of 
this section that are the subject of the exception or alternative 
request;
    (iii) Explain why compliance with such labeling provision(s) could 
adversely affect the safety, effectiveness, or availability of the 
specified lots, batches, or other units of the biological product that 
are or will be included in the Strategic National Stockpile;
    (iv) Describe any proposed safeguards or conditions that will 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 of the product;
    (v) Provide a draft of the proposed labeling of the specified lots, 
batches, or other units of the biological product subject to the 
exception or alternative; and
    (vi) Provide any other information requested by the Center Director 
in support of the request.
    (c) The Center Director must respond in writing to all requests 
under this section.
    (d) A grant of an exception or alternative under this section will 
include any safeguards or conditions deemed appropriate by the Center 
Director so that the labeling of product subject to the exception or 
alternative includes the information necessary for the safe and 
effective use of the product, given the anticipated circumstances of 
use.
    (e) If you are a sponsor receiving a grant of a request for an 
exception or alternative to the labeling requirements under this 
section:
    (1) You need not submit a supplement under Sec.  601.12(f)(1) 
through (f)(2) of this chapter; however,
    (2) You must report any grant of a request for an exception or 
alternative under this section as part of your annual report under 
Sec.  601.12(f)(3) of this chapter.
    (f) The Center Director may grant an exception or alternative under 
this section to the following provisions of this chapter, to the extent 
that the requirements in these provisions are not explicitly required 
by statute:
    (1) Sec.  610.60;
    (2) Sec.  610.61(c) and (e) through (r);
    (3) Sec.  610.62;
    (4) Sec.  610.63;
    (5) Sec.  610.64;
    (6) Sec.  610.65; and
    (7) Sec.  312.6.

PART 801--LABELING

0
11. The authority citation for 21 CFR part 801 continues to read as 
follows:

[[Page 73601]]

    Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.

0
12. Add Sec.  801.128 to subpart D to read as follows:

Sec.  801.128  Exceptions or alternatives to labeling requirements for 
medical devices held by the Strategic National Stockpile.

    (a) The appropriate FDA Center Director may grant an exception or 
alternative to any provision listed in paragraph (f) of this section 
and not explicitly required by statute, for specified lots, batches, or 
other units of a medical device, if the Center Director determines that 
compliance with such labeling requirement could adversely affect the 
safety, effectiveness, or availability of such devices that are or will 
be included in the Strategic National Stockpile.
    (b)(1)(i) A Strategic National Stockpile official or any entity 
that manufactures (including labeling, packing, relabeling, or 
repackaging), distributes, or stores devices that are or will be 
included in the Strategic National Stockpile may submit, with written 
concurrence from a Strategic National Stockpile official, a written 
request for an exception or alternative described in paragraph (a) of 
this section to the Center Director.
    (ii) The Center Director may grant an exception or alternative 
described in paragraph (a) of this section on his or her own 
initiative.
    (2) A written request for an exception or alternative described in 
paragraph (a) of this section must:
    (i) Identify the specified lots, batches, or other units of the 
medical device that would be subject to the exception or alternative;
    (ii) Identify the labeling provision(s) listed in paragraph (f) of 
this section that are the subject of the exception or alternative 
request;
    (iii) Explain why compliance with the labeling provision(s) could 
adversely affect the safety, effectiveness, or availability of the 
specified lots, batches, or other units of a medical device that are or 
will be held in the Strategic National Stockpile;
    (iv) Describe any proposed safeguards or conditions that will be 
implemented so that the labeling of the device includes appropriate 
information necessary for the safe and effective use of the device, 
given the anticipated circumstances of use of the device;
    (v) Provide a draft of the proposed labeling of the specified lots, 
batches, or other units of the medical device subject to the exception 
or alternative; and
    (vi) Provide any other information requested by the Center Director 
in support of the request.
    (c) The Center Director must respond in writing to all requests 
under this section. The Center Director may impose appropriate 
conditions when granting such an exception or alternative under this 
section.
    (d) A grant of an exception or alternative under this section will 
include any safeguards or conditions deemed appropriate by the Center 
Director so that the labeling of devices subject to the exception or 
alternative includes the information necessary for the safe and 
effective use of the device, given the anticipated circumstances of 
use.
    (e) If the Center Director grants a request for an exception or 
alternative to the labeling requirements under this section:
    (1) The Center Director may determine that the submission and grant 
of a written request under this section satisfies the provisions 
relating to premarket notification submissions under Sec.  807.81(a)(3) 
of this chapter.
    (2)(i) For a Premarket Approval Application (PMA)-approved device, 
the submission and grant of a written request under this section 
satisfies the provisions relating to submission of PMA supplements 
under Sec.  814.39 of this chapter; however,
    (ii) The grant of the request must be identified in a periodic 
report under Sec.  814.84 of this chapter.
    (f) The Center Director may grant an exception or alternative under 
this section to the following provisions of this chapter, to the extent 
that the requirements in these provisions are not explicitly required 
by statute:
    (1) Sec.  801.1(d);
    (2) Sec.  801.60;
    (3) Sec.  801.61;
    (4) Sec.  801.62;
    (5) Sec.  801.63;
    (6) Sec.  801.109; and
    (7) Part 801, subpart H.

PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR 
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

0
13. The authority citation for 21 CFR part 807 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i, 
360j, 371, 374, 381, 393; 42 U.S.C. 264, 271.

0
14. Section 807.81 is amended by revising paragraph (b) to read as 
follows:

Sec.  807.81  When a premarket notification submission is required.

* * * * *
    (b)(1) A premarket notification under this subpart is not required 
for a device for which a premarket approval application under section 
515 of the act, or for which a petition to reclassify under section 
513(f)(2) of the act, is pending before the Food and Drug 
Administration.
    (2) The appropriate FDA Center Director may determine that the 
submission and grant of a written request for an exception or 
alternative under Sec.  801.128 or Sec.  809.11 of this chapter 
satisfies the requirement in paragraph (a)(3) of this section.
* * * * *

PART 809--IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

0
15. The authority citation for 21 CFR part 809 continues to read as 
follows:

    Authority: 21 U.S.C. 331, 351, 352, 355, 360b, 360c, 360d, 360h, 
360i, 360j, 371, 372, 374, 381.

0
16. Add Sec.  809.11 to subpart B to read as follows:

Sec.  809.11  Exceptions or alternatives to labeling requirements for 
in vitro diagnostic products for human use held by the Strategic 
National Stockpile.

    (a) The appropriate FDA Center Director may grant an exception or 
alternative to any provision listed in paragraph (f) of this section 
and not explicitly required by statute, for specified lots, batches, or 
other units of an in vitro diagnostic product for human use, if the 
Center Director determines that compliance with such labeling 
requirement could adversely affect the safety, effectiveness, or 
availability of such products that are or will be included in the 
Strategic National Stockpile.
    (b)(1)(i) A Strategic National Stockpile official or any entity 
that manufactures (including labeling, packing, relabeling, or 
repackaging), distributes, or stores an in vitro diagnostic product for 
human use that is or will be included in the Strategic National 
Stockpile may submit, with written concurrence from a Strategic 
National Stockpile official, a written request for an exception or 
alternative described in paragraph (a) of this section to the Center 
Director.
    (ii) The Center Director may grant an exception or alternative 
described in paragraph (a) of this section on his or her own 
initiative.
    (2) A written request for an exception or alternative described in 
paragraph (a) of this section must:
    (i) Identify the specified lots, batches, or other units of an in 
vitro diagnostic product for human use that would be subject to the 
exception or alternative;
    (ii) Identify the labeling provision(s) listed in paragraph (f) of 
this section that are the subject of the exception or alternative 
request;
    (iii) Explain why compliance with such labeling provision(s) could

[[Page 73602]]

adversely affect the safety, effectiveness, or availability of the 
specified lots, batches, or other units of the in vitro diagnostic 
product for human use that are or will be held in the Strategic 
National Stockpile;
    (iv) Describe any proposed safeguards or conditions that will 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 of the product;
    (v) Provide a draft of the proposed labeling of the specified lots, 
batches, or other units of the in vitro diagnostic products for human 
use subject to the exception or alternative; and
    (vi) Provide any other information requested by the Center Director 
in support of the request.
    (c) The Center Director must respond in writing to all requests 
under this section. The Center Director may impose appropriate 
conditions or safeguards when granting such an exception or alternative 
under this section.
    (d) A grant of an exception or alternative under this section will 
include any safeguards or conditions deemed appropriate by the Center 
Director to ensure that the labeling of the product subject to the 
exception or alternative includes the information necessary for the 
safe and effective use of the product, given the anticipated 
circumstances of use.
    (e) If the Center Director grants a request for an exception or 
alternative to the labeling requirements under this section:
    (1) The Center Director may determine that the submission and grant 
of a written request under this section satisfies the provisions 
relating to premarket notification submissions under Sec.  807.81(a)(3) 
of this chapter.
    (2)(i) For a Premarket Approval Application (PMA)-approved in vitro 
diagnostic product for human use, the submission and grant of a written 
request under this section satisfies the provisions relating to 
submission of PMA supplements under Sec.  814.39 of this chapter; 
however,
    (ii) The grant of the request must be identified in a periodic 
report under Sec.  814.84 of this chapter.
    (f) The Center Director may grant an exception or alternative under 
this section to the following provisions of this part, to the extent 
that the requirements in these provisions are not explicitly required 
by statute:
    (1) Sec.  809.10(a)(1) through (a)(6) and (a)(9);
    (2) Sec.  809.10(b);
    (3) Sec.  809.10(c)(2);
    (4) Sec.  809.10(d)(1)(i) through (d)(1)(v), (d)(1)(viii), and 
(d)(2); and
    (5) Sec.  809.10(e)(1)(i) through (e)(1)(vi) and (e)(1)(ix) through 
(e)(1)(xi).

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

0
17. The authority citation for 21 CFR part 812 continues to read as 
follows:

    Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 
360h-360j, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C. 216, 241, 
262, 263b-263n.

0
18. Section 812.5 is amended by adding paragraph (d) to read as 
follows:

Sec.  812.5  Labeling of investigational devices.

* * * * *
    (d) The appropriate FDA Center Director, according to the 
procedures set forth in Sec.  801.128 or Sec.  809.11 of this chapter, 
may grant an exception or alternative to the provisions in paragraphs 
(a) and (c) of this section, to the extent that these provisions are 
not explicitly required by statute, for specified lots, batches, or 
other units of a device that are or will be included in the Strategic 
National Stockpile.

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
19. The authority citation for 21 CFR part 814 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 
373, 374, 375, 379, 379e, 381.

0
20. Section 814.39 is amended by adding paragraph (g) to read as 
follows:

Sec.  814.39  PMA Supplements.

* * * * *
    (g) The submission and grant of a written request for an exception 
or alternative under Sec.  801.128 or Sec.  809.11 of this chapter 
satisfies the requirement in paragraph (a) of this section.

0
21. Section 814.84 is amended by adding paragraph (b)(3) to read as 
follows:

Sec.  814.84  Reports.

* * * * *
    (b) * * *
    (3) Identify changes made pursuant to an exception or alternative 
granted under Sec.  801.128 or Sec.  809.11 of this chapter.

    Dated: December 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-25165 Filed 12-27-07; 8:45 am]

BILLING CODE 4160-01-S