80_FR_55415 80 FR 55237 - Administrative Destruction of Certain Drugs Refused Admission to the United States

80 FR 55237 - Administrative Destruction of Certain Drugs Refused Admission to the United States

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 178 (September 15, 2015)

Page Range55237-55242
FR Document2015-23124

The Food and Drug Administration (FDA or Agency) is implementing its authority to destroy a drug valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been refused admission into the United States under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), by issuing a rule that provides to the owner or consignee notice and an opportunity to appear and introduce testimony to the Agency prior to destruction. This regulation is authorized by amendments made to the FD&C Act by the Food and Drug Administration Safety and Innovation Act (FDASIA). Implementation of this authority will allow FDA to better protect the public health by providing an administrative process for the destruction of certain refused drugs, thus increasing the integrity of the drug supply chain.

Federal Register, Volume 80 Issue 178 (Tuesday, September 15, 2015)
[Federal Register Volume 80, Number 178 (Tuesday, September 15, 2015)]
[Rules and Regulations]
[Pages 55237-55242]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-23124]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2014-N-0504]
RIN 0910-AH12


Administrative Destruction of Certain Drugs Refused Admission to 
the United States

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
implementing its authority to destroy a drug valued at $2,500 or less 
(or such higher amount as the Secretary of the Treasury may set by 
regulation) that has been refused admission into the United States 
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), by 
issuing a rule that provides to the owner or consignee notice and an 
opportunity to appear and introduce testimony to the Agency prior to 
destruction. This regulation is authorized by amendments made to the 
FD&C Act by the Food and Drug Administration Safety and Innovation Act 
(FDASIA). Implementation of this authority will allow FDA to better 
protect the public health by providing an administrative process for 
the destruction of certain refused drugs, thus increasing the integrity 
of the drug supply chain.

DATES: This rule is effective October 15, 2015.

FOR FURTHER INFORMATION CONTACT: Ann M. Metayer, Office of Regulatory 
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 4338, Silver Spring, MD 20993-0002, 301-796-3324, 
[email protected].

SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Regulatory Action

    Implementation of FDA's administrative destruction authority will 
better protect the integrity of the

[[Page 55238]]

drug supply chain by providing a disincentive for the importation of 
drugs that are adulterated, misbranded, or unapproved in violation of 
section 505 of the FD&C Act (21 U.S.C. 355) (unapproved drugs) and 
reducing the likelihood of such drugs being refused admission and 
subsequently offered for reimportation. In 2012, Congress amended 
section 801(a) of the FD&C Act (21 U.S.C. 381(a)) to provide FDA with 
the authority to destroy a refused drug valued at $2,500 or less (or 
such higher amount as the Secretary of the Treasury may set by 
regulation) without providing the owner or consignee with the 
opportunity to export the drug. Congress directed FDA to issue 
regulations that provide the drug's owner or consignee with notice and 
an opportunity to present testimony to the Agency prior to the drug's 
destruction (section 708 of FDASIA). The final rule provides the owner 
or consignee of a drug that has been refused admission into the United 
States, and that is valued at $2,500 or less (or such higher amount as 
the Secretary of the Treasury may set by regulation) with: (1) Written 
notice that FDA intends to destroy the drug and (2) an opportunity to 
present testimony to the Agency before the drug is destroyed.
    FDA is issuing this final rule under section 801(a) of the FD&C 
Act.

Summary of the Major Provisions

    The final rule implements the authority of FDA to destroy a drug 
after providing the owner or consignee of a drug that has been refused 
admission into the United States under section 801(a) of the FD&C Act, 
and that is valued at $2,500 or less (or such higher amount as the 
Secretary of the Treasury may set by regulation) with: (1) Written 
notice that FDA intends to destroy the drug and (2) an opportunity to 
present testimony to the Agency before the drug is destroyed.
    FDA is amending part 1 (21 CFR part 1) by expanding the scope of 
Sec.  1.94 (21 CFR 1.94) to include administrative destruction. 
Currently this provision provides the owner or consignee of an FDA-
regulated product offered for import into the United States with notice 
and opportunity to present testimony to the Agency prior to refusal of 
admission of the product. The final rule expands the scope of Sec.  
1.94 to also provide an owner or consignee with notice and opportunity 
to present testimony to the Agency prior to the destruction of certain 
refused drugs.
    Section 708 of FDASIA and the final rule allow FDA to provide two 
separate notices and hearings--one for refusal of admission and one for 
destruction of a refused drug product--or to combine both notices and 
hearings into one notice and proceeding. Whether the determinations 
occur separately or in one combined proceeding, the determination of 
refusal and the determination regarding destruction of a drug will be 
made separately by the Agency as the findings are separate and 
distinct.

Costs and Benefits

    The primary public health benefit from adoption of the rule would 
be the value of the illnesses and deaths avoided because FDA destroyed 
a drug valued at $2,500 or less (or such higher amount as the Secretary 
of the Treasury may set by regulation) that posed a public health risk. 
This benefit accrues whenever the Agency's other enforcement tools 
would not have prevented a drug, including a biological product, which 
does not comply with the requirements of the FD&C Act (violative drug) 
from entering the U.S. market. The estimated primary costs of the final 
rule include the additional costs to destroy a violative drug and the 
one-time costs of updating the FDA Operational and Administrative 
System for Import Support (OASIS), making appropriate revisions to 
Chapter 9 of the FDA Regulatory Procedures Manual (RPM) and the 
Agency's internal import operations guidelines, and training for FDA 
personnel. FDA estimates the quantifiable net annual effect of the 
final rule to range between a cost of $54,325 and a cost savings of 
$901,950 for an estimated 15,100 destructions each year. The Agency 
estimates that it will also incur one-time costs of $531,670.

I. Background and Legal Authority

    In the Federal Register of May 6, 2014 (79 FR 25758), FDA proposed 
a rule to implement its new authority under section 708 of FDASIA to 
destroy a refused drug valued at $2,500 or less (or such higher amount 
as the Secretary of the Treasury may set by regulation). As discussed 
in the preamble to the proposed rule, President Obama signed FDASIA 
(Pub. L. 112-144) into law on July 9, 2012. Title VII of FDASIA 
provides FDA with important new authorities to help the Agency better 
protect the integrity of the drug supply chain. One of those new 
authorities is provided in section 708 of FDASIA, which amends section 
801(a) of the FD&C Act, to provide FDA with the authority to use an 
administrative procedure to destroy a drug valued at $2,500 or less (or 
such higher amount as the Secretary of the Treasury may set by 
regulation) that was not brought into compliance as described in 
section 801(b) of the FD&C Act and was refused admission into the 
United States. Section 708 of FDASIA authorizes FDA to use this new 
administrative procedure without offering the owner or consignee the 
opportunity to export the drug. The statute further provides that FDA 
will store and, as applicable, dispose of the drug that the Agency 
intends to destroy. The drug's owner or consignee is liable for FDA's 
storage and disposal costs under section 801(c) of the FD&C Act.
    Section 708 of FDASIA directs FDA to issue regulations that provide 
the owner or consignee of a drug designated by the Agency for 
administrative destruction with notice and an opportunity to introduce 
testimony to the Agency prior to the destruction of the drug. The 
provision further states that this process may be combined with the 
notice and opportunity to appear before FDA and introduce testimony on 
the admissibility of the drug under section 801(a) of the FD&C Act, as 
long as appropriate notice is provided to the owner or consignee.

II. Overview of the Final Rule Including Changes to the Proposed Rule

    FDA is amending part 1 to implement the administrative destruction 
of refused drugs. The amendment to part 1 consists of amendments to 
Sec.  1.94, including two technical changes to Sec.  1.94(b) where 
``his'' is now changed to ``his or her'' and ``act'' is now changed to 
``Federal Food, Drug, and Cosmetic Act'' in the final rule. No changes 
have been made to the proposed regulation and, therefore, FDA is 
finalizing the implementing regulation as proposed.

III. Comments on the Proposed Rule

    FDA received 22 comments in the public docket for the May 6, 2014, 
proposed rule by the close of the comment period, July 7, 2014, each 
containing one or more comments. One comment was received in the public 
docket on July 8, 2014, 1 day after the docket closed. These comments 
were submitted by consumers, consumer advocacy groups, industry and 
trade organizations, industry, and a member of Congress. One comment 
consisted of a ``placeholder'' and did not contain any substantive 
remarks.
    After considering the comments responsive to the proposed rule, the 
Agency is not making any changes to the regulatory language included in 
the proposed rule.
    This section contains summaries of the relevant portions of the 
responsive comments and the Agency's responses to those comments. To 
make it easier to

[[Page 55239]]

identify the comments and our responses, the word ``Comment,'' in 
parentheses, appears before the comment's description, and the word 
``Response,'' in parentheses, appears before our response. We have 
numbered each comment and response to help distinguish between 
different types of comments. Similar comments are grouped together 
under the same number. The number assigned to each comment is purely 
for organizational purposes and does not signify the comment's value, 
importance, or the order in which it was received.
    The Agency also received some general comments that were not 
responsive to the content of the rule, and therefore were not 
considered in its final development. Some of these comments, however, 
are summarized in this section and the Agency responded to those 
comments to provide clarity for the public and industry on the Agency's 
implementation of its administrative destruction authority under 
section 708 of FDASIA.

A. Notice and Hearing Process

    Two comments suggested that FDA modify the notice and hearing 
process in the proposed rule.
    (Comment 1) One comment asserted that the procedure set forth in 
Sec.  1.94 appears to apply only to large commercial drug imports, not 
drugs offered for import by individuals, and that FDA should create a 
separate administrative hearing process for individuals.
    (Response 1) The proposed rule amends Sec.  1.94 to add 
administrative destruction of certain drugs to the current 
administrative hearing process for refusal of admission of an FDA-
regulated product. The current rule applies to all imports regardless 
of how they enter the United States, e.g., via a commercial port or an 
International Mail Facility (IMF), and regardless of who seeks to 
import the drug. As amended by this final rule, Sec.  1.94 will provide 
an administrative hearing process to any owner or consignee of a 
refused drug with a value of $2,500 or less (or such higher amount as 
the Secretary of the Treasury may set by regulation) that FDA intends 
to destroy whether that owner or consignee is an individual owner or 
consignee or a commercial importer. There is, therefore, no need to 
establish a separate administrative hearing process for individuals 
whose drugs have been refused and designated for administrative 
destruction.
    (Comment 2) One comment stated that FDA should provide clarity for 
consumers regarding how they can introduce testimony to the Agency to 
challenge the administrative destruction of drugs they attempted to 
import but which were refused admission. The comment suggested that FDA 
allow testimony to be submitted by an affected owner or consignee 
through an online platform, email, regular mail, or facsimile and that 
the Agency include a supplemental document in the notice that instructs 
consumers on how to provide testimony to FDA to prevent administrative 
destruction of their drugs.
    (Response 2) As described in Chapter 9 of the RPM, the type of 
administrative hearing under Sec.  1.94 may vary from a series of 
telephone conversations to a more formal procedure. Introduction of 
testimony by the owner or consignee for Agency review and consideration 
can take many forms, including a telephone conversation, a facsimile, 
or mail, and does not have to be introduced in person. However, an in-
person hearing will be scheduled if requested by the owner or 
consignee. (http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074300.pdf). Current Agency procedures 
also allow such testimony to be submitted by the owner or consignee by 
email. Under the final rule, owners or consignees will have the same 
options for submitting testimony in opposition to the destruction of 
their drugs. Given the variety of options historically available to 
owners and consignees for submission of testimony, which will continue 
under the final rule, FDA does not believe that a dedicated online 
platform for submission of testimony is currently needed. If 
circumstances change in the future, FDA will consider whether such a 
system is appropriate.
    FDA recognizes that an owner or consignee importing a drug for his/
her own personal use may need information about the administrative 
hearing process when that drug has been detained by FDA for 
administrative destruction. Accordingly, the Agency will provide 
information on the administrative hearing process under Sec.  1.94, as 
amended in this rule, by providing an insert in the Agency's notice of 
detention or by establishing a Web page on the FDA Web site containing 
information about the administrative destruction process including ways 
to submit testimony to the Agency in opposition to the destruction of a 
drug. FDA will also consider issuing guidance or other explanatory 
materials, as appropriate.

B. Drugs Subject to Administrative Destruction by FDA

    Two comments requested clarity regarding what drugs will be 
destroyed by FDA under section 708 of FDASIA.
    (Comment 3) Two commenters requested clarity on when a refused drug 
will be destroyed under section 708 of FDASIA and when the Agency will 
give the owner or consignee the option to destroy or export a refused 
drug.
    (Response 3) Currently, owners or consignees of drugs that have 
been refused admission into the United States under section 801(a) of 
the FD&C Act have the option to destroy or export those drugs. Drugs 
imported via an IMF that have been refused admission are sent back to 
the United States Postal Service (USPS) for export. After 
implementation of section 708 of FDASIA, FDA anticipates that owners or 
consignees will still have the option to destroy or export a refused 
drug in at least two situations. First, only a drug valued at $2,500 or 
less (or such higher amount as the Secretary of the Treasury may set by 
regulation) is subject to administrative destruction under section 708 
of FDASIA. Owners or consignees of a drug valued over the current 
$2,500 threshold that has been refused admission will still have the 
option to destroy or export that drug unless the drug has been imported 
via an IMF. For a drug valued at $2,500 or less (or such higher amount 
as the Secretary of the Treasury may set by regulation) that has been 
refused admission, section 708 of FDASIA allows FDA to destroy the drug 
without providing the owner or consignee with the opportunity to 
destroy or export the drug.
    The second situation where owners or consignees will still have the 
option to destroy or export a refused drug is when FDA refuses 
admission to a drug, including a biological product, that is subject to 
destruction under section 708 of FDASIA, but the Agency is not able to 
make a determination that the drug is, in fact, adulterated, 
misbranded, or unapproved in violation of section 505 of the FD&C Act. 
As stated in the proposed rule, FDA intends to administratively destroy 
a drug only where the Agency has made a determination that the drug is 
adulterated, misbranded, or is an unapproved drug. There may be 
situations where the Agency refuses admission to a drug that is valued 
at $2,500 or less (or such higher amount as the Secretary of the 
Treasury may set by regulation) because it appears to be an 
adulterated, misbranded, or unapproved

[[Page 55240]]

drug but the Agency does not have sufficient information to make a 
determination that the drug is, in fact, an adulterated, misbranded, or 
unapproved drug. Under those circumstances, the owner or consignee will 
be given the opportunity to destroy or export that refused drug. If 
such a drug has come into the United States via an IMF, however, FDA 
will generally return the drug to the USPS for export.

C. Storage and Destruction Costs of Drugs Designated for Destruction

    Section 708 of FDASIA provides that FDA will store and, as 
applicable, dispose of a drug where the Agency has made the 
determination to destroy that drug. The drug's owner or consignee is 
liable for FDA's storage and disposal costs under section 801(c) of the 
FD&C Act.
    (Comment 4) One comment asked when FDA will take physical 
possession of drugs designated for destruction at express courier 
facilities and expressed concern about the possibility of extended 
storage time for these drugs at the expense of the express courier. The 
commenter also requested clarification regarding whether an express 
courier could be held liable for the costs of storage and destruction 
of a refused drug under section 801(c) of the FD&C Act.
    (Response 4) If FDA designates a drug for possible destruction that 
has been offered for import into the United States via an express 
courier, FDA intends to take physical possession of that drug when the 
Agency has made the determination to destroy the drug. The Agency 
expects that by combining the notice and introduction of testimony on 
destruction with the notice and introduction of testimony on refusal of 
admission, any additional storage time at an express courier due to 
implementation of section 708 of FDASIA will be minimal.
    An express courier is not liable for the storage or destruction 
costs under section 801(c) of the FD&C Act unless that courier is also 
the owner or consignee of a destroyed drug, which would be unusual. As 
stated in the proposed rule, if a drug is sent by international mail, 
FDA generally considers the addressee of the parcel to be the owner or 
consignee of the drug.
    (Comment 5) One commenter requested that FDA clearly define and 
outline the storage and destruction costs to consumers under section 
801(c) of the FD&C Act and that the Agency provide offsets to those 
costs for consumers unable to pay due to financial stress.
    (Response 5) FDA generally does not intend to pursue recovery of 
storage and destruction costs under section 801(c) of the FD&C Act 
against individual consumers who seek to import a drug for their own 
personal use that is then refused and destroyed by the Agency under 
section 708 of FDASIA.

D. General Comments

    The final rule provides the owner or consignee of a drug valued at 
$2,500 or less (or such higher amount as the Secretary of the Treasury 
may set by regulation) that is refused admission into the United States 
with: (1) Written notice that FDA intends to destroy the drug and (2) 
an opportunity to present testimony to the Agency before the drug is 
destroyed.
    (Comment 6) Many comments made general remarks expressing support 
or opposition to the authority granted to FDA by section 708 of FDASIA 
to administratively destroy certain refused drugs and did not focus on 
the rule or a particular section of the rule.
    One comment supported the administrative destruction of certain 
refused drugs while several comments expressed concern about the 
potential impact of administrative destruction on a consumer's access 
to foreign drugs. These comments cited a patient's inability to comply 
with a drug treatment plan as a consequence of that lack of access. One 
comment requested that FDA change its current Personal Importation 
Policy to allow importation of any drug from a ``safe'' foreign 
pharmacy or for which there is a ``valid'' prescription. The comment 
further requested that FDA define the term ``safe personal drug 
import'' in the final rule.
    (Response 6) As required for implementation of section 708 of 
FDASIA, the final rule provides appropriate due process to the owner or 
consignee of a drug that has been refused admission under section 
801(a) of the FD&C Act, and that FDA intends to destroy. The new 
authority granted to FDA by section 708 of FDASIA to administratively 
destroy a drug applies only after the Agency has made the final 
decision to refuse admission to the drug. This new authority, 
therefore, does not affect a consumer's access to a foreign drug 
because consumers have no access to a refused drug under the FD&C Act. 
The final rule does not modify FDA's current policy with respect to 
personal importation of drugs.
    (Comment 7) One comment suggested that implementation of section 
708 of FDASIA could adversely affect the supply of low-value excipients 
and other drug components potentially leading to a drug shortage. The 
commenter suggested that FDA closely coordinate with manufacturers to 
limit the impact on the drug supply chain when the Agency exercises its 
authority to destroy low-value excipients or other drug components. The 
commenter further suggested that FDA's Drug Shortages Task Force 
monitor and publicly report on the effects of section 708 of FDASIA on 
the drug supply in the United States.
    (Response 7) Excipients and other components of a drug are defined 
as drugs under section 201(g)(1) of the FD&C Act. An excipient or other 
drug component is therefore subject to administrative destruction under 
section 708 of FDASIA if that excipient or drug component offered for 
import is valued at $2,500 or less (or such higher amount as the 
Secretary of the Treasury may set by regulation) and is refused 
admission. FDA does not expect that administrative destruction of 
refused excipients or other drug components will lead to shortages of 
medically necessary drugs. The majority of excipients and drug 
components are imported into the United States as commercial entries. 
Currently, where excipients or drug components are refused admission, 
they are exported or destroyed. Refused excipients or other drug 
components, therefore, are not currently available for drug 
manufacturing in the United States. The Agency's exercise of 
administrative destruction will not affect a manufacturer's access to 
these refused excipients or other drug components and, therefore, will 
not contribute to shortages of drugs manufactured in the United States.
    (Comment 8) One comment asserted that FDA only quantified the 
benefits but not the costs of the proposed rule which, according to the 
comment, should include the societal costs attributable to a patient's 
lack of access to an imported drug that does not pose a public health 
risk, and that patient's non-adherence to a medical plan that includes 
such drug.
    (Response 8) In the proposed rule, FDA estimated both the costs and 
the benefits of the implementation of section 708 of FDASIA and the 
result was a quantifiable net annual social benefit. The detailed 
analysis of the estimated economic impact as provided in Ref. 10 in the 
proposed rule can be found at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm#.
    The preliminary Regulatory Impact Analysis did not include any 
costs attributable to lack of access to an imported drug by a patient 
as this is not a cost attributable to administrative destruction. 
Currently, drugs that are

[[Page 55241]]

refused admission are destroyed or exported by the importer or, in the 
case of international mail, returned to the USPS for export. 
Consequently, patients do not have access to those drugs. Only refused 
drugs are subject to administrative destruction under section 708 of 
FDASIA and, therefore, implementation of this authority does not result 
in a quantifiable cost to be included in the regulatory impact analysis 
of the implementation of section 708.
    (Comment 9) A number of comments requested that FDA flag shipments 
in Customs and Border Protection's Automated Commercial System (ACS) or 
the Automated Commercial Environment (ACE) system, which is expected to 
replace ACS by December 2016, when a drug is destroyed. Another comment 
suggested that FDA establish a public database listing drugs destroyed 
by FDA under the authority of section 708 of FDASIA.
    (Response 9) These comments relate to the Agency's operations 
implementing the final rule and, as FDA stated in the proposed rule, 
the Agency plans to specify the operational details of its process for 
destruction by guidance, operating guidelines, or similar means.

IV. Analysis of Impacts (Summary of the Final Regulatory Impact 
Analysis)

    FDA has examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct 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 final rule is not a significant 
regulatory action under Executive Order 12866.
    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 small number of expected destructions 
each year and the very small value per event, the Agency certifies that 
this 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 finalizing ``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 $141 million, using the most current (2013) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.
    The primary public health benefit from adoption of the rule will be 
the value of the illnesses or deaths avoided because the Agency 
destroyed a refused drug valued at $2,500 or less (or such higher 
amount as the Secretary of the Treasury may set by regulation) that 
posed a public health risk. Additionally, the final rule may benefit 
firms through increases in sales, brand value, and investment in 
research and development if the destroyed drug is a counterfeit or an 
otherwise falsified version of an approved drug. The threat of 
destruction may also have a deterrent effect resulting in a reduction 
in the amount of violative drugs shipped into the United States in the 
future. These benefits accrue whenever the Agency's other enforcement 
tools would not have prevented a violative drug from entering the U.S. 
market. The current procedure whereby a drug refused admission might be 
exported does not ensure that the drug would not be imported into the 
United States in the future. These benefits are not quantified.
    The estimated primary costs to FDA include the additional costs 
incurred by FDA to destroy a refused drug as opposed to the costs 
related to exportation of the drug and the one-time costs of updating 
OASIS, revising Chapter 9 of the RPM and other internal import 
operations guidelines, and training for FDA personnel. Our estimates of 
the primary costs assume that all refused drugs valued at $2,500 or 
less (or such higher amount as the Secretary of the Treasury may set by 
regulation) would be destroyed (estimated 15,100 destructions performed 
each year), that FDA would contract the act of destruction out to 
another government agency or private firm, and the notice and hearing 
process for destruction will be combined with the current FDA notice 
and hearing process for refusal of drugs. The assumption that FDA will 
destroy all refused drugs represents an upper bound and may not always 
hold. If FDA chooses to destroy less than all of the refused drugs, all 
annual costs will decrease but the one-time costs will stay the same.
    Based on an assumed 15,100 administrative destructions performed 
each year, the Agency estimates the quantifiable net annual effect of 
the final rule to be between a cost of $54,325 and a cost savings of 
$901,950, in addition to one-time costs of $531,670. Annualized over 20 
years, the final rule is estimated to produce a net effect ranging from 
a cost of $89,021 to a cost savings of $867,254 at a 3 percent discount 
rate and a cost of $101,228 to a cost savings of $855,047 at a 7 
percent discount rate. The present discounted value of the quantifiable 
net effect over 20 years ranges from a cost of $1,324,403 to a cost 
savings of $12,902,554 at a 3 percent discount rate and a cost of 
$1,072,408 to a cost savings of $9,058,383 at a 7 percent discount 
rate.
    Our estimates do not include net benefits of the final rule because 
we have not quantified the potential health benefits of reducing the 
probability that a refused drug will be imported into the United States 
in the future. However, because the final rule likely represents a cost 
savings and the health benefits, though not quantified, will be 
positive even if one violative drug that would have caused an adverse 
event is destroyed rather than entering the U.S. market, the net 
benefits of the rule are likely positive.
    FDA has examined the economic implications of the final rule as 
required by the Regulatory Flexibility Act. If a rule will have 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. U.S. Federal Government Agencies will bear the costs of the 
final rule with FDA bearing most of the cost as the Agency is 
responsible under section 708 of FDASIA for implementation of the rule 
and for the costs of storage and destruction. Therefore we certify that 
this final rule will not have a significant economic impact on a 
substantial number of small entities. This analysis, together with 
other relevant sections of this document, serves as the Final 
Regulatory Flexibility Analysis, as required under the Regulatory 
Flexibility Act.
    The full discussion of economic impacts, which includes a list of 
changes made in the final regulatory impact analysis, is available in 
Docket No. FDA-2014-N-0504 and at http://www.fda.gov/AboutFDA/
ReportsManualsForms/Reports/

[[Page 55242]]

EconomicAnalyses/default.htm# (Ref. 1).

V. Paperwork Reduction Act of 1995

    This final rule contains no collection of information under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3518(c)(1)(B)(ii)). 
Therefore, clearance by the Office of Management and Budget is not 
required under the Paperwork Reduction Act of 1995.

VI. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the Agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

VII. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) 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.

VIII. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and is available electronically at http://www.regulations.gov. (FDA has 
verified the Web site address in this Reference section, but FDA is not 
responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register.)

    1. Final Regulatory Impact Analysis, Final Regulatory 
Flexibility Analysis, and Final Unfunded Mandates Reform Act 
Analysis for Administrative Destruction of Certain Drugs Refused 
Admission to the United States, available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm#.

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, 21 CFR 
part 1 is amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

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

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 
350d, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 
381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264.


0
2. Revise Sec.  1.94 to read as follows:


Sec.  1.94  Hearing on refusal of admission or destruction.

    (a) If it appears that the article may be subject to refusal of 
admission, or that the article is a drug that may be subject to 
destruction under section 801(a) of the Federal Food, Drug, and 
Cosmetic Act, the district director shall give the owner or consignee a 
written notice to that effect, stating the reasons therefor. The notice 
shall specify a place and a period of time during which the owner or 
consignee shall have an opportunity to introduce testimony. Upon timely 
request giving reasonable grounds therefor, such time and place may be 
changed. Such testimony shall be confined to matters relevant to the 
admissibility or destruction of the article, and may be introduced 
orally or in writing.
    (b) If such owner or consignee submits or indicates his or her 
intention to submit an application for authorization to relabel or 
perform other action to bring the article into compliance with the 
Federal Food, Drug, and Cosmetic Act or to render it other than a food, 
drug, device, or cosmetic, such testimony shall include evidence in 
support of such application. If such application is not submitted at or 
prior to the hearing on refusal of admission, the district director 
shall specify a time limit, reasonable in the light of the 
circumstances, for filing such application.
    (c) If the article is a drug that may be subject to destruction 
under section 801(a) of the Federal Food, Drug, and Cosmetic Act, the 
district director may give the owner or consignee a single written 
notice that provides the notice on refusal of admission and the notice 
on destruction of an article described in paragraph (a) of this 
section. The district director may also combine the hearing on refusal 
of admission with the hearing on destruction of the article described 
in paragraph (a) of this section into a single proceeding.

    Dated: September 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23124 Filed 9-14-15; 8:45 am]
 BILLING CODE 4164-01-P



                                                                 Federal Register / Vol. 80, No. 178 / Tuesday, September 15, 2015 / Rules and Regulations                                            55237

                                                § 39.13   [Amended]                                       (iii) If any magnetic particles, including            Issued in Burlington, Massachusetts, on
                                                                                                        fuzz, are seen, determine with laboratory             August 28, 2015.
                                                ■ 2. The FAA amends § 39.13 by adding
                                                                                                        analysis if the particles are 73-tooth or 41-         Ann C. Mollica,
                                                the following new airworthiness
                                                                                                        tooth gearshaft material.                             Acting Directorate Manager, Engine &
                                                directive (AD):
                                                                                                          (iv) If the particles are 73-tooth or 41-tooth      Propeller Directorate, Aircraft Certification
                                                2015–18–04 CFM International S.A.:                      gearshaft material, remove the affected               Service.
                                                    Amendment 39–18262; Docket No.                      gearshaft(s) within 75 FHs since the AGB/             [FR Doc. 2015–22598 Filed 9–14–15; 8:45 am]
                                                    FAA–2015–0277; Directorate Identifier               TGB MCD inspection.
                                                    2015–NE–05–AD.                                                                                            BILLING CODE 4910–13–P
                                                                                                        (f) Mandatory Terminating Action
                                                (a) Effective Date
                                                                                                          (1) Remove the affected 73-tooth gearshaft
                                                  This AD is effective October 20, 2015.                                                                      DEPARTMENT OF HEALTH AND
                                                                                                        prior to the gearshaft accumulating 6,000 FHs
                                                (b) Affected ADs                                        since new or within 50 FHs after the effective        HUMAN SERVICES
                                                  None.                                                 date of this AD, whichever comes later.
                                                                                                          (2) Remove the affected 41-tooth gearshaft          Food and Drug Administration
                                                (c) Applicability                                       prior to the gearshaft accumulating 9,000 FHs
                                                   This AD applies to CFM International S.A.            since new or within 50 FHs after the effective        21 CFR Part 1
                                                (CFM) CFM56–7B and CFM56–3 engines                      date of this AD, whichever comes later.
                                                with a 73-tooth or 41-tooth gearshaft installed                                                               [Docket No. FDA–2014–N–0504]
                                                in the accessory gearbox (AGB), that has a              (g) Installation Prohibition                          RIN 0910–AH12
                                                gearshaft serial number in Appendix A or                  After the effective date of this AD, do not
                                                Appendix B of CFM Service Bulletin (SB) No.             install an affected gearshaft into an AGB.            Administrative Destruction of Certain
                                                CFM56–7B S/B 72–0964, Revision 1, dated                                                                       Drugs Refused Admission to the
                                                December 15, 2014.                                      (h) Alternative Methods of Compliance                 United States
                                                                                                        (AMOCs)
                                                (d) Unsafe Condition
                                                                                                          The Manager, Engine Certification Office,           AGENCY:    Food and Drug Administration,
                                                   This AD was prompted by a report of an
                                                                                                        FAA, may approve AMOCs for this AD. Use               HHS.
                                                uncommanded in-flight shutdown on a CFM
                                                CFM56–7B engine following rupture of the                the procedures found in 14 CFR 39.19 to               ACTION:   Final rule.
                                                73-tooth gearshaft located in the engine AGB.           make your request. You may email your
                                                We are issuing this AD to prevent failure of            request to: ANE-AD-AMOC@faa.gov.                      SUMMARY:   The Food and Drug
                                                certain AGB gearshafts, which could lead to                                                                   Administration (FDA or Agency) is
                                                                                                        (i) Related Information
                                                failure of one or more engines, loss of thrust                                                                implementing its authority to destroy a
                                                control, and damage to the airplane.                      For more information about this AD,                 drug valued at $2,500 or less (or such
                                                                                                        contact Kyle Gustafson, Aerospace Engineer,           higher amount as the Secretary of the
                                                (e) Compliance
                                                                                                        Engine Certification Office, FAA, Engine &            Treasury may set by regulation) that has
                                                   Comply with this AD within the                       Propeller Directorate, 12 New England
                                                compliance times specified, unless already                                                                    been refused admission into the United
                                                                                                        Executive Park, Burlington, MA 01803;                 States under the Federal Food, Drug,
                                                done.                                                   phone: 781–238–7183; fax: 781–238–7199;               and Cosmetic Act (the FD&C Act), by
                                                (1) Initial AGB/Transfer Gearbox (TGB)/                 email: kyle.gustafson@faa.gov.                        issuing a rule that provides to the owner
                                                Magnetic Chip Detector (MCD) Inspection
                                                                                                        (j) Material Incorporated by Reference                or consignee notice and an opportunity
                                                and Analysis
                                                                                                           (1) The Director of the Federal Register           to appear and introduce testimony to
                                                   (i) For affected 73-tooth gearshafts, perform                                                              the Agency prior to destruction. This
                                                an AGB/TGB MCD inspection within 250                    approved the incorporation by reference
                                                flight hours (FHs) since last inspection,               (IBR) of the service information listed in this       regulation is authorized by amendments
                                                within 25 FHs from the effective date of this           paragraph under 5 U.S.C. 552(a) and 1 CFR             made to the FD&C Act by the Food and
                                                AD, or when the gearshaft accumulates 3,000             part 51.                                              Drug Administration Safety and
                                                FHs since new, whichever comes later.                      (2) You must use this service information          Innovation Act (FDASIA).
                                                   (ii) For affected 41-tooth gearshafts,               as applicable to do the actions required by           Implementation of this authority will
                                                perform an AGB/TGB MCD inspection within                this AD, unless the AD specifies otherwise.           allow FDA to better protect the public
                                                250 FHs since last inspection, within 25 FHs               (3) The following service information was          health by providing an administrative
                                                from the effective date of this AD, or when             approved for IBR on October 20, 2015.                 process for the destruction of certain
                                                the gearshaft accumulates 6,000 FHs since
                                                new, whichever comes later.
                                                                                                           (i) CFM International Service Bulletin No.         refused drugs, thus increasing the
                                                                                                        CFM56–7B S/B 72–0964, Revision 1, dated               integrity of the drug supply chain.
                                                   (iii) If any magnetic particles, including
                                                fuzz, are seen, determine with laboratory               December 15, 2014.                                    DATES: This rule is effective October 15,
                                                analysis if the particles are 73-tooth or 41-              (ii) Reserved.                                     2015.
                                                tooth gearshaft material.                                  (4) For CFM service information identified
                                                                                                        in this AD, contact CFM International Inc.,           FOR FURTHER INFORMATION CONTACT: Ann
                                                   (iv) If the particles are 73-tooth or 41-tooth
                                                gearshaft material, remove the affected                 Aviation Operations Center, 1 Neumann                 M. Metayer, Office of Regulatory Affairs,
                                                gearshaft(s) within 75 FHs since the AGB/               Way, M/D Room 285, Cincinnati, OH 45125;              Food and Drug Administration, 10903
                                                TGB MCD inspection.                                     phone: 877–432–3272; fax: 877–432–3329;               New Hampshire Ave., Bldg. 32, Rm.
                                                                                                        email: aviation.fleetsupport@ge.com.                  4338, Silver Spring, MD 20993–0002,
                                                (2) Repetitive AGB/TGB MCD Inspection and
                                                                                                           (5) You may view this service information          301–796–3324,
                                                Analysis
                                                                                                        at FAA, Engine & Propeller Directorate, 12            FDASIAImplementationORA@
                                                  (i) For affected 73-tooth gearshafts, perform                                                               fda.hhs.gov.
                                                                                                        New England Executive Park, Burlington,
                                                an AGB/TGB MCD inspection and laboratory
                                                                                                        MA. For information on the availability of
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                                                analysis within every 500 FHs since the last                                                                  SUPPLEMENTARY INFORMATION:
                                                AGB/TGB MCD inspection until affected                   this material at the FAA, call 781–238–7125.
                                                gearshaft is removed.                                      (6) You may view this service information          Executive Summary
                                                  (ii) For affected 41-tooth gearshafts,                at the National Archives and Records
                                                                                                                                                              Purpose of the Regulatory Action
                                                perform an AGB/TGB MCD inspection and                   Administration (NARA). For information on
                                                laboratory analysis within every 500 FHs                the availability of this material at NARA, call         Implementation of FDA’s
                                                since the last AGB/TGB MCD inspection                   202–741–6030, or go to: http://www.archives.          administrative destruction authority
                                                until affected gearshaft is removed.                    gov/federal-register/cfr/ibr-locations.html.          will better protect the integrity of the


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                                                55238            Federal Register / Vol. 80, No. 178 / Tuesday, September 15, 2015 / Rules and Regulations

                                                drug supply chain by providing a                        refused drug product—or to combine                    compliance as described in section
                                                disincentive for the importation of drugs               both notices and hearings into one                    801(b) of the FD&C Act and was refused
                                                that are adulterated, misbranded, or                    notice and proceeding. Whether the                    admission into the United States.
                                                unapproved in violation of section 505                  determinations occur separately or in                 Section 708 of FDASIA authorizes FDA
                                                of the FD&C Act (21 U.S.C. 355)                         one combined proceeding, the                          to use this new administrative
                                                (unapproved drugs) and reducing the                     determination of refusal and the                      procedure without offering the owner or
                                                likelihood of such drugs being refused                  determination regarding destruction of a              consignee the opportunity to export the
                                                admission and subsequently offered for                  drug will be made separately by the                   drug. The statute further provides that
                                                reimportation. In 2012, Congress                        Agency as the findings are separate and               FDA will store and, as applicable,
                                                amended section 801(a) of the FD&C Act                  distinct.                                             dispose of the drug that the Agency
                                                (21 U.S.C. 381(a)) to provide FDA with                                                                        intends to destroy. The drug’s owner or
                                                                                                        Costs and Benefits
                                                the authority to destroy a refused drug                                                                       consignee is liable for FDA’s storage and
                                                valued at $2,500 or less (or such higher                   The primary public health benefit                  disposal costs under section 801(c) of
                                                amount as the Secretary of the Treasury                 from adoption of the rule would be the                the FD&C Act.
                                                may set by regulation) without                          value of the illnesses and deaths                        Section 708 of FDASIA directs FDA to
                                                providing the owner or consignee with                   avoided because FDA destroyed a drug                  issue regulations that provide the owner
                                                the opportunity to export the drug.                     valued at $2,500 or less (or such higher              or consignee of a drug designated by the
                                                Congress directed FDA to issue                          amount as the Secretary of the Treasury               Agency for administrative destruction
                                                regulations that provide the drug’s                     may set by regulation) that posed a                   with notice and an opportunity to
                                                owner or consignee with notice and an                   public health risk. This benefit accrues              introduce testimony to the Agency prior
                                                opportunity to present testimony to the                 whenever the Agency’s other                           to the destruction of the drug. The
                                                Agency prior to the drug’s destruction                  enforcement tools would not have                      provision further states that this process
                                                (section 708 of FDASIA). The final rule                 prevented a drug, including a biological              may be combined with the notice and
                                                provides the owner or consignee of a                    product, which does not comply with                   opportunity to appear before FDA and
                                                drug that has been refused admission                    the requirements of the FD&C Act                      introduce testimony on the
                                                into the United States, and that is                     (violative drug) from entering the U.S.               admissibility of the drug under section
                                                valued at $2,500 or less (or such higher                market. The estimated primary costs of                801(a) of the FD&C Act, as long as
                                                amount as the Secretary of the Treasury                 the final rule include the additional                 appropriate notice is provided to the
                                                may set by regulation) with: (1) Written                costs to destroy a violative drug and the             owner or consignee.
                                                notice that FDA intends to destroy the                  one-time costs of updating the FDA
                                                                                                        Operational and Administrative System                 II. Overview of the Final Rule Including
                                                drug and (2) an opportunity to present
                                                                                                        for Import Support (OASIS), making                    Changes to the Proposed Rule
                                                testimony to the Agency before the drug
                                                is destroyed.                                           appropriate revisions to Chapter 9 of the                FDA is amending part 1 to implement
                                                   FDA is issuing this final rule under                 FDA Regulatory Procedures Manual                      the administrative destruction of
                                                section 801(a) of the FD&C Act.                         (RPM) and the Agency’s internal import                refused drugs. The amendment to part 1
                                                                                                        operations guidelines, and training for               consists of amendments to § 1.94,
                                                Summary of the Major Provisions                         FDA personnel. FDA estimates the                      including two technical changes to
                                                   The final rule implements the                        quantifiable net annual effect of the                 § 1.94(b) where ‘‘his’’ is now changed to
                                                authority of FDA to destroy a drug after                final rule to range between a cost of                 ‘‘his or her’’ and ‘‘act’’ is now changed
                                                providing the owner or consignee of a                   $54,325 and a cost savings of $901,950                to ‘‘Federal Food, Drug, and Cosmetic
                                                drug that has been refused admission                    for an estimated 15,100 destructions                  Act’’ in the final rule. No changes have
                                                into the United States under section                    each year. The Agency estimates that it               been made to the proposed regulation
                                                801(a) of the FD&C Act, and that is                     will also incur one-time costs of                     and, therefore, FDA is finalizing the
                                                valued at $2,500 or less (or such higher                $531,670.                                             implementing regulation as proposed.
                                                amount as the Secretary of the Treasury
                                                                                                        I. Background and Legal Authority                     III. Comments on the Proposed Rule
                                                may set by regulation) with: (1) Written
                                                notice that FDA intends to destroy the                     In the Federal Register of May 6, 2014                FDA received 22 comments in the
                                                drug and (2) an opportunity to present                  (79 FR 25758), FDA proposed a rule to                 public docket for the May 6, 2014,
                                                testimony to the Agency before the drug                 implement its new authority under                     proposed rule by the close of the
                                                is destroyed.                                           section 708 of FDASIA to destroy a                    comment period, July 7, 2014, each
                                                   FDA is amending part 1 (21 CFR part                  refused drug valued at $2,500 or less (or             containing one or more comments. One
                                                1) by expanding the scope of § 1.94 (21                 such higher amount as the Secretary of                comment was received in the public
                                                CFR 1.94) to include administrative                     the Treasury may set by regulation). As               docket on July 8, 2014, 1 day after the
                                                destruction. Currently this provision                   discussed in the preamble to the                      docket closed. These comments were
                                                provides the owner or consignee of an                   proposed rule, President Obama signed                 submitted by consumers, consumer
                                                FDA-regulated product offered for                       FDASIA (Pub. L. 112–144) into law on                  advocacy groups, industry and trade
                                                import into the United States with                      July 9, 2012. Title VII of FDASIA                     organizations, industry, and a member
                                                notice and opportunity to present                       provides FDA with important new                       of Congress. One comment consisted of
                                                testimony to the Agency prior to refusal                authorities to help the Agency better                 a ‘‘placeholder’’ and did not contain any
                                                of admission of the product. The final                  protect the integrity of the drug supply              substantive remarks.
                                                rule expands the scope of § 1.94 to also                chain. One of those new authorities is                   After considering the comments
                                                provide an owner or consignee with                      provided in section 708 of FDASIA,                    responsive to the proposed rule, the
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                                                notice and opportunity to present                       which amends section 801(a) of the                    Agency is not making any changes to
                                                testimony to the Agency prior to the                    FD&C Act, to provide FDA with the                     the regulatory language included in the
                                                destruction of certain refused drugs.                   authority to use an administrative                    proposed rule.
                                                   Section 708 of FDASIA and the final                  procedure to destroy a drug valued at                    This section contains summaries of
                                                rule allow FDA to provide two separate                  $2,500 or less (or such higher amount as              the relevant portions of the responsive
                                                notices and hearings—one for refusal of                 the Secretary of the Treasury may set by              comments and the Agency’s responses
                                                admission and one for destruction of a                  regulation) that was not brought into                 to those comments. To make it easier to


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                                                                 Federal Register / Vol. 80, No. 178 / Tuesday, September 15, 2015 / Rules and Regulations                                     55239

                                                identify the comments and our                           introduce testimony to the Agency to                  B. Drugs Subject to Administrative
                                                responses, the word ‘‘Comment,’’ in                     challenge the administrative destruction              Destruction by FDA
                                                parentheses, appears before the                         of drugs they attempted to import but                    Two comments requested clarity
                                                comment’s description, and the word                     which were refused admission. The                     regarding what drugs will be destroyed
                                                ‘‘Response,’’ in parentheses, appears                   comment suggested that FDA allow                      by FDA under section 708 of FDASIA.
                                                before our response. We have numbered                   testimony to be submitted by an affected                 (Comment 3) Two commenters
                                                each comment and response to help                       owner or consignee through an online                  requested clarity on when a refused
                                                distinguish between different types of                  platform, email, regular mail, or                     drug will be destroyed under section
                                                comments. Similar comments are                          facsimile and that the Agency include a               708 of FDASIA and when the Agency
                                                grouped together under the same                         supplemental document in the notice                   will give the owner or consignee the
                                                number. The number assigned to each                     that instructs consumers on how to                    option to destroy or export a refused
                                                comment is purely for organizational                    provide testimony to FDA to prevent                   drug.
                                                purposes and does not signify the                       administrative destruction of their                      (Response 3) Currently, owners or
                                                comment’s value, importance, or the                     drugs.                                                consignees of drugs that have been
                                                order in which it was received.                                                                               refused admission into the United States
                                                   The Agency also received some                           (Response 2) As described in Chapter
                                                                                                        9 of the RPM, the type of administrative              under section 801(a) of the FD&C Act
                                                general comments that were not
                                                                                                        hearing under § 1.94 may vary from a                  have the option to destroy or export
                                                responsive to the content of the rule,
                                                                                                        series of telephone conversations to a                those drugs. Drugs imported via an IMF
                                                and therefore were not considered in its
                                                                                                        more formal procedure. Introduction of                that have been refused admission are
                                                final development. Some of these
                                                                                                        testimony by the owner or consignee for               sent back to the United States Postal
                                                comments, however, are summarized in
                                                                                                        Agency review and consideration can                   Service (USPS) for export. After
                                                this section and the Agency responded
                                                                                                        take many forms, including a telephone                implementation of section 708 of
                                                to those comments to provide clarity for
                                                                                                        conversation, a facsimile, or mail, and               FDASIA, FDA anticipates that owners or
                                                the public and industry on the Agency’s
                                                                                                        does not have to be introduced in                     consignees will still have the option to
                                                implementation of its administrative
                                                destruction authority under section 708                 person. However, an in-person hearing                 destroy or export a refused drug in at
                                                of FDASIA.                                              will be scheduled if requested by the                 least two situations. First, only a drug
                                                                                                        owner or consignee. (http://                          valued at $2,500 or less (or such higher
                                                A. Notice and Hearing Process                           www.fda.gov/downloads/ICECI/                          amount as the Secretary of the Treasury
                                                  Two comments suggested that FDA                       ComplianceManuals/                                    may set by regulation) is subject to
                                                modify the notice and hearing process                   RegulatoryProceduresManual/                           administrative destruction under
                                                in the proposed rule.                                   UCM074300.pdf). Current Agency                        section 708 of FDASIA. Owners or
                                                  (Comment 1) One comment asserted                      procedures also allow such testimony to               consignees of a drug valued over the
                                                that the procedure set forth in § 1.94                  be submitted by the owner or consignee                current $2,500 threshold that has been
                                                appears to apply only to large                          by email. Under the final rule, owners                refused admission will still have the
                                                commercial drug imports, not drugs                      or consignees will have the same                      option to destroy or export that drug
                                                offered for import by individuals, and                  options for submitting testimony in                   unless the drug has been imported via
                                                that FDA should create a separate                       opposition to the destruction of their                an IMF. For a drug valued at $2,500 or
                                                administrative hearing process for                      drugs. Given the variety of options                   less (or such higher amount as the
                                                individuals.                                            historically available to owners and                  Secretary of the Treasury may set by
                                                  (Response 1) The proposed rule                                                                              regulation) that has been refused
                                                                                                        consignees for submission of testimony,
                                                amends § 1.94 to add administrative                                                                           admission, section 708 of FDASIA
                                                                                                        which will continue under the final
                                                destruction of certain drugs to the                                                                           allows FDA to destroy the drug without
                                                                                                        rule, FDA does not believe that a
                                                current administrative hearing process                                                                        providing the owner or consignee with
                                                                                                        dedicated online platform for
                                                for refusal of admission of an FDA-                                                                           the opportunity to destroy or export the
                                                                                                        submission of testimony is currently
                                                regulated product. The current rule                                                                           drug.
                                                                                                        needed. If circumstances change in the                   The second situation where owners or
                                                applies to all imports regardless of how
                                                                                                        future, FDA will consider whether such                consignees will still have the option to
                                                they enter the United States, e.g., via a
                                                                                                        a system is appropriate.                              destroy or export a refused drug is when
                                                commercial port or an International
                                                Mail Facility (IMF), and regardless of                     FDA recognizes that an owner or                    FDA refuses admission to a drug,
                                                who seeks to import the drug. As                        consignee importing a drug for his/her                including a biological product, that is
                                                amended by this final rule, § 1.94 will                 own personal use may need information                 subject to destruction under section 708
                                                provide an administrative hearing                       about the administrative hearing process              of FDASIA, but the Agency is not able
                                                process to any owner or consignee of a                  when that drug has been detained by                   to make a determination that the drug is,
                                                refused drug with a value of $2,500 or                  FDA for administrative destruction.                   in fact, adulterated, misbranded, or
                                                less (or such higher amount as the                      Accordingly, the Agency will provide                  unapproved in violation of section 505
                                                Secretary of the Treasury may set by                    information on the administrative                     of the FD&C Act. As stated in the
                                                regulation) that FDA intends to destroy                 hearing process under § 1.94, as                      proposed rule, FDA intends to
                                                whether that owner or consignee is an                   amended in this rule, by providing an                 administratively destroy a drug only
                                                individual owner or consignee or a                      insert in the Agency’s notice of                      where the Agency has made a
                                                commercial importer. There is,                          detention or by establishing a Web page               determination that the drug is
                                                therefore, no need to establish a separate              on the FDA Web site containing                        adulterated, misbranded, or is an
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                                                administrative hearing process for                      information about the administrative                  unapproved drug. There may be
                                                individuals whose drugs have been                       destruction process including ways to                 situations where the Agency refuses
                                                refused and designated for                              submit testimony to the Agency in                     admission to a drug that is valued at
                                                administrative destruction.                             opposition to the destruction of a drug.              $2,500 or less (or such higher amount as
                                                  (Comment 2) One comment stated                        FDA will also consider issuing guidance               the Secretary of the Treasury may set by
                                                that FDA should provide clarity for                     or other explanatory materials, as                    regulation) because it appears to be an
                                                consumers regarding how they can                        appropriate.                                          adulterated, misbranded, or unapproved


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                                                55240            Federal Register / Vol. 80, No. 178 / Tuesday, September 15, 2015 / Rules and Regulations

                                                drug but the Agency does not have                       destruction costs under section 801(c) of             coordinate with manufacturers to limit
                                                sufficient information to make a                        the FD&C Act against individual                       the impact on the drug supply chain
                                                determination that the drug is, in fact,                consumers who seek to import a drug                   when the Agency exercises its authority
                                                an adulterated, misbranded, or                          for their own personal use that is then               to destroy low-value excipients or other
                                                unapproved drug. Under those                            refused and destroyed by the Agency                   drug components. The commenter
                                                circumstances, the owner or consignee                   under section 708 of FDASIA.                          further suggested that FDA’s Drug
                                                will be given the opportunity to destroy                                                                      Shortages Task Force monitor and
                                                                                                        D. General Comments
                                                or export that refused drug. If such a                                                                        publicly report on the effects of section
                                                drug has come into the United States via                   The final rule provides the owner or               708 of FDASIA on the drug supply in
                                                an IMF, however, FDA will generally                     consignee of a drug valued at $2,500 or               the United States.
                                                return the drug to the USPS for export.                 less (or such higher amount as the                       (Response 7) Excipients and other
                                                                                                        Secretary of the Treasury may set by                  components of a drug are defined as
                                                C. Storage and Destruction Costs of                     regulation) that is refused admission                 drugs under section 201(g)(1) of the
                                                Drugs Designated for Destruction                        into the United States with: (1) Written              FD&C Act. An excipient or other drug
                                                   Section 708 of FDASIA provides that                  notice that FDA intends to destroy the                component is therefore subject to
                                                FDA will store and, as applicable,                      drug and (2) an opportunity to present                administrative destruction under
                                                dispose of a drug where the Agency has                  testimony to the Agency before the drug               section 708 of FDASIA if that excipient
                                                made the determination to destroy that                  is destroyed.                                         or drug component offered for import is
                                                drug. The drug’s owner or consignee is                     (Comment 6) Many comments made                     valued at $2,500 or less (or such higher
                                                liable for FDA’s storage and disposal                   general remarks expressing support or                 amount as the Secretary of the Treasury
                                                costs under section 801(c) of the FD&C                  opposition to the authority granted to                may set by regulation) and is refused
                                                Act.                                                    FDA by section 708 of FDASIA to                       admission. FDA does not expect that
                                                   (Comment 4) One comment asked                        administratively destroy certain refused              administrative destruction of refused
                                                when FDA will take physical possession                  drugs and did not focus on the rule or                excipients or other drug components
                                                of drugs designated for destruction at                  a particular section of the rule.                     will lead to shortages of medically
                                                express courier facilities and expressed                   One comment supported the                          necessary drugs. The majority of
                                                concern about the possibility of                        administrative destruction of certain                 excipients and drug components are
                                                extended storage time for these drugs at                refused drugs while several comments                  imported into the United States as
                                                the expense of the express courier. The                 expressed concern about the potential                 commercial entries. Currently, where
                                                commenter also requested clarification                  impact of administrative destruction on               excipients or drug components are
                                                regarding whether an express courier                    a consumer’s access to foreign drugs.                 refused admission, they are exported or
                                                could be held liable for the costs of                   These comments cited a patient’s                      destroyed. Refused excipients or other
                                                storage and destruction of a refused                    inability to comply with a drug                       drug components, therefore, are not
                                                drug under section 801(c) of the FD&C                   treatment plan as a consequence of that               currently available for drug
                                                Act.                                                    lack of access. One comment requested                 manufacturing in the United States. The
                                                   (Response 4) If FDA designates a drug                that FDA change its current Personal                  Agency’s exercise of administrative
                                                for possible destruction that has been                  Importation Policy to allow importation               destruction will not affect a
                                                offered for import into the United States               of any drug from a ‘‘safe’’ foreign                   manufacturer’s access to these refused
                                                via an express courier, FDA intends to                  pharmacy or for which there is a ‘‘valid’’            excipients or other drug components
                                                take physical possession of that drug                   prescription. The comment further                     and, therefore, will not contribute to
                                                when the Agency has made the                            requested that FDA define the term                    shortages of drugs manufactured in the
                                                determination to destroy the drug. The                  ‘‘safe personal drug import’’ in the final            United States.
                                                Agency expects that by combining the                    rule.                                                    (Comment 8) One comment asserted
                                                notice and introduction of testimony on                    (Response 6) As required for                       that FDA only quantified the benefits
                                                destruction with the notice and                         implementation of section 708 of                      but not the costs of the proposed rule
                                                introduction of testimony on refusal of                 FDASIA, the final rule provides                       which, according to the comment,
                                                admission, any additional storage time                  appropriate due process to the owner or               should include the societal costs
                                                at an express courier due to                            consignee of a drug that has been                     attributable to a patient’s lack of access
                                                implementation of section 708 of                        refused admission under section 801(a)                to an imported drug that does not pose
                                                FDASIA will be minimal.                                 of the FD&C Act, and that FDA intends                 a public health risk, and that patient’s
                                                   An express courier is not liable for the             to destroy. The new authority granted to              non-adherence to a medical plan that
                                                storage or destruction costs under                      FDA by section 708 of FDASIA to                       includes such drug.
                                                section 801(c) of the FD&C Act unless                   administratively destroy a drug applies                  (Response 8) In the proposed rule,
                                                that courier is also the owner or                       only after the Agency has made the final              FDA estimated both the costs and the
                                                consignee of a destroyed drug, which                    decision to refuse admission to the drug.             benefits of the implementation of
                                                would be unusual. As stated in the                      This new authority, therefore, does not               section 708 of FDASIA and the result
                                                proposed rule, if a drug is sent by                     affect a consumer’s access to a foreign               was a quantifiable net annual social
                                                international mail, FDA generally                       drug because consumers have no access                 benefit. The detailed analysis of the
                                                considers the addressee of the parcel to                to a refused drug under the FD&C Act.                 estimated economic impact as provided
                                                be the owner or consignee of the drug.                  The final rule does not modify FDA’s                  in Ref. 10 in the proposed rule can be
                                                   (Comment 5) One commenter                            current policy with respect to personal               found at http://www.fda.gov/AboutFDA/
                                                requested that FDA clearly define and                   importation of drugs.                                 ReportsManualsForms/Reports/
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                                                outline the storage and destruction costs                  (Comment 7) One comment suggested                  EconomicAnalyses/default.htm#.
                                                to consumers under section 801(c) of the                that implementation of section 708 of                    The preliminary Regulatory Impact
                                                FD&C Act and that the Agency provide                    FDASIA could adversely affect the                     Analysis did not include any costs
                                                offsets to those costs for consumers                    supply of low-value excipients and                    attributable to lack of access to an
                                                unable to pay due to financial stress.                  other drug components potentially                     imported drug by a patient as this is not
                                                   (Response 5) FDA generally does not                  leading to a drug shortage. The                       a cost attributable to administrative
                                                intend to pursue recovery of storage and                commenter suggested that FDA closely                  destruction. Currently, drugs that are


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                                                                 Federal Register / Vol. 80, No. 178 / Tuesday, September 15, 2015 / Rules and Regulations                                       55241

                                                refused admission are destroyed or                      benefits, before finalizing ‘‘any rule that           decrease but the one-time costs will stay
                                                exported by the importer or, in the case                includes any Federal mandate that may                 the same.
                                                of international mail, returned to the                  result in the expenditure by State, local,               Based on an assumed 15,100
                                                USPS for export. Consequently, patients                 and tribal governments, in the aggregate,             administrative destructions performed
                                                do not have access to those drugs. Only                 or by the private sector, of $100,000,000             each year, the Agency estimates the
                                                refused drugs are subject to                            or more (adjusted annually for inflation)             quantifiable net annual effect of the
                                                administrative destruction under                        in any one year.’’ The current threshold              final rule to be between a cost of
                                                section 708 of FDASIA and, therefore,                   after adjustment for inflation is $141                $54,325 and a cost savings of $901,950,
                                                implementation of this authority does                   million, using the most current (2013)                in addition to one-time costs of
                                                not result in a quantifiable cost to be                 Implicit Price Deflator for the Gross                 $531,670. Annualized over 20 years, the
                                                included in the regulatory impact                       Domestic Product. FDA does not expect                 final rule is estimated to produce a net
                                                analysis of the implementation of                       this final rule to result in any 1-year               effect ranging from a cost of $89,021 to
                                                section 708.                                            expenditure that would meet or exceed                 a cost savings of $867,254 at a 3 percent
                                                  (Comment 9) A number of comments                      this amount.                                          discount rate and a cost of $101,228 to
                                                requested that FDA flag shipments in                       The primary public health benefit                  a cost savings of $855,047 at a 7 percent
                                                Customs and Border Protection’s                         from adoption of the rule will be the                 discount rate. The present discounted
                                                Automated Commercial System (ACS)                       value of the illnesses or deaths avoided              value of the quantifiable net effect over
                                                or the Automated Commercial                             because the Agency destroyed a refused                20 years ranges from a cost of
                                                Environment (ACE) system, which is                      drug valued at $2,500 or less (or such                $1,324,403 to a cost savings of
                                                expected to replace ACS by December                     higher amount as the Secretary of the                 $12,902,554 at a 3 percent discount rate
                                                2016, when a drug is destroyed. Another                 Treasury may set by regulation) that                  and a cost of $1,072,408 to a cost
                                                comment suggested that FDA establish a                  posed a public health risk. Additionally,             savings of $9,058,383 at a 7 percent
                                                public database listing drugs destroyed                 the final rule may benefit firms through              discount rate.
                                                by FDA under the authority of section                   increases in sales, brand value, and                     Our estimates do not include net
                                                708 of FDASIA.                                          investment in research and                            benefits of the final rule because we
                                                  (Response 9) These comments relate
                                                                                                        development if the destroyed drug is a                have not quantified the potential health
                                                to the Agency’s operations
                                                                                                        counterfeit or an otherwise falsified                 benefits of reducing the probability that
                                                implementing the final rule and, as FDA
                                                                                                        version of an approved drug. The threat               a refused drug will be imported into the
                                                stated in the proposed rule, the Agency
                                                                                                        of destruction may also have a deterrent              United States in the future. However,
                                                plans to specify the operational details
                                                                                                        effect resulting in a reduction in the                because the final rule likely represents
                                                of its process for destruction by
                                                                                                        amount of violative drugs shipped into                a cost savings and the health benefits,
                                                guidance, operating guidelines, or
                                                                                                        the United States in the future. These                though not quantified, will be positive
                                                similar means.
                                                                                                        benefits accrue whenever the Agency’s                 even if one violative drug that would
                                                IV. Analysis of Impacts (Summary of                     other enforcement tools would not have                have caused an adverse event is
                                                the Final Regulatory Impact Analysis)                   prevented a violative drug from entering              destroyed rather than entering the U.S.
                                                   FDA has examined the impacts of the                  the U.S. market. The current procedure                market, the net benefits of the rule are
                                                final rule under Executive Order 12866,                 whereby a drug refused admission                      likely positive.
                                                Executive Order 13563, the Regulatory                   might be exported does not ensure that                   FDA has examined the economic
                                                Flexibility Act (5 U.S.C. 601–612), and                 the drug would not be imported into the               implications of the final rule as required
                                                the Unfunded Mandates Reform Act of                     United States in the future. These                    by the Regulatory Flexibility Act. If a
                                                1995 (Pub. L. 104–4). Executive Orders                  benefits are not quantified.                          rule will have a significant economic
                                                12866 and 13563 direct Agencies to                         The estimated primary costs to FDA                 impact on a substantial number of small
                                                assess all costs and benefits of available              include the additional costs incurred by              entities, the Regulatory Flexibility Act
                                                regulatory alternatives and, when                       FDA to destroy a refused drug as                      requires Agencies to analyze regulatory
                                                regulation is necessary, to select                      opposed to the costs related to                       options that would lessen the economic
                                                regulatory approaches that maximize                     exportation of the drug and the one-time              effect of the rule on small entities. U.S.
                                                net benefits (including potential                       costs of updating OASIS, revising                     Federal Government Agencies will bear
                                                economic, environmental, public health                  Chapter 9 of the RPM and other internal               the costs of the final rule with FDA
                                                and safety, and other advantages;                       import operations guidelines, and                     bearing most of the cost as the Agency
                                                distributive impacts; and equity). The                  training for FDA personnel. Our                       is responsible under section 708 of
                                                Agency believes that this final rule is                 estimates of the primary costs assume                 FDASIA for implementation of the rule
                                                not a significant regulatory action under               that all refused drugs valued at $2,500               and for the costs of storage and
                                                Executive Order 12866.                                  or less (or such higher amount as the                 destruction. Therefore we certify that
                                                   The Regulatory Flexibility Act                       Secretary of the Treasury may set by                  this final rule will not have a significant
                                                requires Agencies to analyze regulatory                 regulation) would be destroyed                        economic impact on a substantial
                                                options that would minimize any                         (estimated 15,100 destructions                        number of small entities. This analysis,
                                                significant impact of a rule on small                   performed each year), that FDA would                  together with other relevant sections of
                                                entities. Because of the small number of                contract the act of destruction out to                this document, serves as the Final
                                                expected destructions each year and the                 another government agency or private                  Regulatory Flexibility Analysis, as
                                                very small value per event, the Agency                  firm, and the notice and hearing process              required under the Regulatory
                                                certifies that this final rule will not have            for destruction will be combined with                 Flexibility Act.
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                                                a significant economic impact on a                      the current FDA notice and hearing                       The full discussion of economic
                                                substantial number of small entities.                   process for refusal of drugs. The                     impacts, which includes a list of
                                                   Section 202(a) of the Unfunded                       assumption that FDA will destroy all                  changes made in the final regulatory
                                                Mandates Reform Act of 1995 requires                    refused drugs represents an upper                     impact analysis, is available in Docket
                                                that Agencies prepare a written                         bound and may not always hold. If FDA                 No. FDA–2014–N–0504 and at http://
                                                statement, which includes an                            chooses to destroy less than all of the               www.fda.gov/AboutFDA/
                                                assessment of anticipated costs and                     refused drugs, all annual costs will                  ReportsManualsForms/Reports/


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                                                55242            Federal Register / Vol. 80, No. 178 / Tuesday, September 15, 2015 / Rules and Regulations

                                                EconomicAnalyses/default.htm#                             Therefore, under the Federal Food,                  paragraph (a) of this section into a single
                                                (Ref. 1).                                               Drug, and Cosmetic Act, and under                     proceeding.
                                                                                                        authority delegated to the Commissioner                 Dated: September 9, 2015.
                                                V. Paperwork Reduction Act of 1995
                                                                                                        of Food and Drugs, 21 CFR part 1 is                   Leslie Kux,
                                                  This final rule contains no collection                amended as follows:
                                                of information under the Paperwork                                                                            Associate Commissioner for Policy.
                                                Reduction Act of 1995 (44 U.S.C.                        PART 1—GENERAL ENFORCEMENT                            [FR Doc. 2015–23124 Filed 9–14–15; 8:45 am]
                                                3518(c)(1)(B)(ii)). Therefore, clearance                REGULATIONS                                           BILLING CODE 4164–01–P
                                                by the Office of Management and
                                                Budget is not required under the                        ■ 1. The authority citation for 21 CFR
                                                Paperwork Reduction Act of 1995.                        part 1 continues to read as follows:                  DEPARTMENT OF STATE
                                                VI. Federalism                                            Authority: 15 U.S.C. 1333, 1453, 1454,
                                                                                                        1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C.           22 CFR Part 22
                                                   FDA has analyzed this final rule in                  321, 331, 332, 333, 334, 335a, 343, 350c,
                                                accordance with the principles set forth                350d, 352, 355, 360b, 360ccc, 360ccc–1,               [Public Notice: 9269]
                                                in Executive Order 13132. FDA has                       360ccc–2, 362, 371, 374, 381, 382, 387, 387a,
                                                determined that the rule does not                       387c, 393; 42 U.S.C. 216, 241, 243, 262, 264.         RIN 1400–AD71
                                                contain policies that have substantial
                                                                                                        ■   2. Revise § 1.94 to read as follows:              Schedule of Fees for Consular
                                                direct effects on the States, on the
                                                                                                                                                              Services, Department of State and
                                                relationship between the National                       § 1.94 Hearing on refusal of admission or             Overseas Embassies and
                                                Government and the States, or on the                    destruction.                                          Consulates—Passport and Citizenship
                                                distribution of power and
                                                                                                           (a) If it appears that the article may be          Services Fee Changes; Correction
                                                responsibilities among the various
                                                                                                        subject to refusal of admission, or that
                                                levels of government. Accordingly, the                                                                        AGENCY:    Department of State.
                                                                                                        the article is a drug that may be subject
                                                Agency has concluded that the rule does                                                                       ACTION:   Interim final rule; correction.
                                                                                                        to destruction under section 801(a) of
                                                not contain policies that have
                                                                                                        the Federal Food, Drug, and Cosmetic
                                                federalism implications as defined in                                                                         SUMMARY:   The Department of State
                                                                                                        Act, the district director shall give the
                                                the Executive order and, consequently,                                                                        published an interim final rule on
                                                                                                        owner or consignee a written notice to
                                                a federalism summary impact statement                                                                         September 8, 2015, amending the
                                                                                                        that effect, stating the reasons therefor.
                                                is not required.                                                                                              Schedule of Fees for Consular Services
                                                                                                        The notice shall specify a place and a
                                                VII. Environmental Impact                               period of time during which the owner                 (Schedule) for certain passport fees and
                                                                                                        or consignee shall have an opportunity                citizenship services fees. The document
                                                   The Agency has determined under 21                                                                         contained an incorrect effective date for
                                                CFR 25.30(h) that this action is of a type              to introduce testimony. Upon timely
                                                                                                        request giving reasonable grounds                     a portion of the rule. This document
                                                that does not individually or                                                                                 corrects the rule.
                                                cumulatively have a significant effect on               therefor, such time and place may be
                                                                                                        changed. Such testimony shall be                      DATES: The effective date of the
                                                the human environment. Therefore,
                                                                                                        confined to matters relevant to the                   amendments to § 22.1, Items 2.(a), 2.(b),
                                                neither an environmental assessment
                                                                                                        admissibility or destruction of the                   and 2.(g), published in the Federal
                                                nor an environmental impact statement
                                                                                                        article, and may be introduced orally or              Register on September 8, 2015 (80 FR
                                                is required.
                                                                                                        in writing.                                           53704), is corrected to September 26,
                                                VIII. Reference                                            (b) If such owner or consignee                     2015.
                                                   The following reference has been                     submits or indicates his or her intention             FOR FURTHER INFORMATION CONTACT:      Jill
                                                placed on display in the Division of                    to submit an application for                          Warning, Special Assistant, Office of the
                                                Dockets Management (HFA–305), Food                      authorization to relabel or perform other             Comptroller, Bureau of Consular Affairs,
                                                and Drug Administration, 5630 Fishers                   action to bring the article into                      Department of State; phone: 202–485–
                                                Lane, Rm. 1061, Rockville, MD 20852,                    compliance with the Federal Food,                     6681, telefax: 202–485–6826; email:
                                                and may be seen by interested persons                   Drug, and Cosmetic Act or to render it                fees@state.gov.
                                                between 9 a.m. and 4 p.m., Monday                       other than a food, drug, device, or                   SUPPLEMENTARY INFORMATION: The
                                                through Friday, and is available                        cosmetic, such testimony shall include                Department of State published an
                                                electronically at http://                               evidence in support of such application.              interim final rule on September 8, 2015
                                                www.regulations.gov. (FDA has verified                  If such application is not submitted at               (80 FR 53704); this document corrects
                                                the Web site address in this Reference                  or prior to the hearing on refusal of                 the effective date for one portion of the
                                                section, but FDA is not responsible for                 admission, the district director shall                rulemaking. The other dates applicable
                                                any subsequent changes to the Web site                  specify a time limit, reasonable in the               to the rulemaking, as well as the
                                                after this document publishes in the                    light of the circumstances, for filing                duration of the public comment period,
                                                Federal Register.)                                      such application.                                     are unchanged.
                                                  1. Final Regulatory Impact Analysis, Final               (c) If the article is a drug that may be
                                                Regulatory Flexibility Analysis, and Final              subject to destruction under section                  Corrections
                                                Unfunded Mandates Reform Act Analysis for               801(a) of the Federal Food, Drug, and                   In FR Rule Doc. 2015–22054, in the
                                                Administrative Destruction of Certain Drugs             Cosmetic Act, the district director may               Federal Register of September 8, 2015
                                                Refused Admission to the United States,
                                                                                                        give the owner or consignee a single                  (80 FR 53704), the following corrections
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                                                available at http://www.fda.gov/AboutFDA/
                                                ReportsManualsForms/Reports/                            written notice that provides the notice               are made:
                                                EconomicAnalyses/default.htm#.                          on refusal of admission and the notice                  1. On page 53704 in the second
                                                                                                        on destruction of an article described in             column, the first sentence of the DATES
                                                List of Subjects in 21 CFR Part 1                       paragraph (a) of this section. The district           section is corrected to read: ‘‘Section
                                                  Cosmetics, Drugs, Exports, Food                       director may also combine the hearing                 22.1, Items 2.(a), 2.(b), and 2.(g) of this
                                                labeling, Imports, Labeling, Reporting                  on refusal of admission with the hearing              rule become effective on September 26,
                                                and recordkeeping requirements.                         on destruction of the article described in            2015.’’


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Document Created: 2015-12-15 10:09:31
Document Modified: 2015-12-15 10:09:31
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis rule is effective October 15, 2015.
ContactAnn M. Metayer, Office of Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4338, Silver Spring, MD 20993-0002, 301-796-3324, [email protected]
FR Citation80 FR 55237 
RIN Number0910-AH12
CFR AssociatedCosmetics; Drugs; Exports; Food Labeling; Imports; Labeling and Reporting and Recordkeeping Requirements

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