80 FR 8087 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 30 (February 13, 2015)

Page Range		8087-8088
FR Document		2015-03005

The Food and Drug Administration is correcting a notice entitled ``Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates '' that appeared in the Federal Register of February 6, 2015 (80 FR 6728). The document announced that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. The document was published with three errors. This document corrects those errors.

Federal Register, Volume 80 Issue 30 (Friday, February 13, 2015)

[Federal Register Volume 80, Number 30 (Friday, February 13, 2015)]
[Notices]
[Pages 8087-8088]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03005]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0161]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Export of Food and 
Drug Administration Regulated Products: Export Certificates; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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

SUMMARY: The Food and Drug Administration is correcting a notice 
entitled ``Agency Information Collection Activities; Submission for 
Office of Management and Budget Review; Comment Request; Export of Food 
and Drug Administration Regulated Products: Export Certificates '' that 
appeared in the Federal Register of February 6, 2015 (80 FR 6728). The 
document announced that a proposed collection of information has been 
submitted to the Office of Management and Budget (OMB) for review and 
clearance under the Paperwork Reduction Act of 1995. The document was 
published with three errors. This document corrects those errors.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, February 
6, 2015, in FR Doc. 2015-02348, the following corrections are made:
    1. On page 6728, in the third column, under the heading Export of 
Food and Drug Administration Regulated Products: Export Certificates--
(OMB Control Number 0910-0498)--Extension, the following sentence is 
added at the end of the first paragraph: ``In January 2011, section 
801(e)(4)(A) was amended by the Food Safety Modernization Act (Pub. L. 
111-353) to provide authorization for export certification fees for 
food and animal feed.''
    2. On page 6728, in the third column, under the heading Export of 
Food and Drug Administration Regulated Products: Export Certificates--
(OMB Control Number 0910-0498)--Extension, in the second paragraph, the 
first sentence is revised to read as follows: ``This section of the 
FD&C Act authorizes FDA to issue export certificates for regulated 
food, animal feed, pharmaceuticals, biologics, and devices that are 
legally marketed in the United States, as well as for these same 
products that are not legally marketed but are acceptable to the 
importing country, as specified in sections 801(e) and 802 of the FD&C 
Act.''
    3. On page 6729, Table 2 is corrected as follows:

[[Page 8088]]



                                 Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                               Number of
                                                  Number of    responses      Total       Average
                   FDA center                    respondents      per         annual     burden per  Total hours
                                                               respondent   responses     response
----------------------------------------------------------------------------------------------------------------
Center for Biologics Evaluation and Research...        2,114            1        2,114            1        2,114
Center for Devices and Radiological Health.....       10,528            1       10,528            2       21,056
Center for Veterinary Medicine.................        1,848            1        1,848            1        1,848
                                                ----------------------------------------------------------------
    Total......................................  ...........  ...........  ...........  ...........       25,018
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: February 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03005 Filed 2-12-15; 8:45 am]
BILLING CODE 4164-01-P

8088 Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual
FDA center burden per Total hours
respondents per responses response
respondent

Center for Biologics Evaluation and Research ........................................ 2,114 1 2,114 1 2,114
Center for Devices and Radiological Health ........................................... 10,528 1 10,528 2 21,056
Center for Veterinary Medicine ................................................................ 1,848 1 1,848 1 1,848

Total .................................................................................................. .................... .................... .................... .................... 25,018
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: February 9, 2015. must, with certain exceptions, show that 2002, and later approved in another
Leslie Kux, the drug for which they are seeking dosage form (sublingual film) on August
Associate Commissioner for Policy. approval contains the same active 30, 2010, under NDA 22–410. In March
[FR Doc. 2015–03005 Filed 2–12–15; 8:45 am] ingredient in the same strength and 2013, Reckitt discontinued marketing
BILLING CODE 4164–01–P dosage form as the ‘‘listed drug,’’ which the sublingual tablet dosage form of
is a version of the drug that was SUBOXONE.1 All three products are
previously approved. Sponsors of approved for treatment of opioid
DEPARTMENT OF HEALTH AND ANDAs do not have to repeat the dependence.2
HUMAN SERVICES extensive clinical testing otherwise Actavis Elizabeth LLC submitted a
necessary to gain approval of a new citizen petition dated August 16, 2013
Food and Drug Administration drug application (NDA). (Docket No. FDA–2013–P–1055), under
[Docket No. FDA–2013–P–1055]
The 1984 amendments include what 21 CFR 10.30, requesting that FDA
is now section 505(j)(7) of the Federal determine whether SUBUTEX was
Determination That SUBUTEX Food, Drug, and Cosmetic Act (21 U.S.C. withdrawn from sale for reasons of
(Buprenorphine Hydrochloride) 355(j)(7)), which requires FDA to safety or effectiveness. The petition
Sublingual Tablets, Equivalent 2 publish a list of all approved drugs. contains no data or other information
Milligrams Base and Equivalent 8 FDA publishes this list as part of the suggesting that SUBUTEX was
Milligrams Base, Were Not Withdrawn ‘‘Approved Drug Products with withdrawn for reasons of safety or
From Sale for Reasons of Safety or Therapeutic Equivalence Evaluations,’’ effectiveness.
Effectiveness which is known generally as the We have carefully reviewed our
‘‘Orange Book.’’ Under FDA regulations, records concerning the withdrawal of
AGENCY: Food and Drug Administration, a drug is removed from the list if the SUBUTEX from sale. Based on the
HHS. Agency withdraws or suspends information we have at this time, FDA
ACTION: Notice. approval of the drug’s NDA or ANDA has determined under § 314.161 that
for reasons of safety or effectiveness or SUBUTEX was not withdrawn for
SUMMARY: The Food and Drug if FDA determines that the listed drug reasons of safety or effectiveness.
Administration (FDA) has determined was withdrawn from sale for reasons of The buprenorphine in both SUBUTEX
that SUBUTEX (buprenorphine safety or effectiveness (21 CFR 314.162). and SUBOXONE is a mu opioid partial
hydrochloride (HCl)) Sublingual Under § 314.161(a) (21 CFR agonist that can precipitate withdrawal
Tablets, Equivalent (Eq) 2 milligrams 314.161(a)), the Agency must determine in patients physically dependent on full
(mg) base and Eq 8 mg base, were not whether a listed drug was withdrawn opioid agonists. That is, the relative
withdrawn from sale for reasons of from sale for reasons of safety or reduction in activity at the mu receptor
safety or effectiveness. This effectiveness: (1) Before an ANDA that when buprenorphine replaces a full
determination means that FDA will not refers to that listed drug may be opioid agonist can cause symptoms of
begin procedures to withdraw approval approved, (2) whenever a listed drug is opioid withdrawal. SUBOXONE also
of abbreviated new drug applications voluntarily withdrawn from sale and contains naloxone. Naloxone is a potent
(ANDAs) that refer to SUBUTEX, and it ANDAs that refer to the listed drug have
will allow FDA to continue to approve been approved, and (3) when a person 1 On September 27, 2012, after Reckitt publicly
ANDAs that refer to SUBUTEX as long petitions for such a determination under announced that it was planning to discontinue the
as they meet relevant legal and 21 CFR 10.25(a) and 10.30.
product, Lachman Consultant Services Inc.
regulatory requirements. (Lachman) submitted a citizen petition requesting
SUBUTEX (buprenorphine HCl) that the Agency determine whether SUBOXONE
FOR FURTHER INFORMATION CONTACT: Sublingual Tablets is the subject of NDA Sublingual Tablets were withdrawn from sale for
Ayako Sato, Center for Drug Evaluation 20–732, held by Reckitt Benckiser reasons of safety or effectiveness (Docket No. FDA–
and Research, Food and Drug Pharmaceuticals, Inc. (Reckitt). It was 2012–P–1034). After considering Lachman’s citizen
petition and reviewing our records, including the
Administration, 10903 New Hampshire approved on October 8, 2002. After analysis that the Agency prepared in connection
Ave., Bldg. 51, Rm. 6228, Silver Spring, Reckitt discontinued marketing with Reckitt’s citizen petition (Docket No. FDA–
MD 20993–0002, 240–402–4191. SUBUTEX in 2011, FDA moved 2012–P–1028), FDA determined that SUBOXONE
SUPPLEMENTARY INFORMATION: In 1984, SUBUTEX to the ‘‘Discontinued Drug Sublingual Tablets was not discontinued for
reasons of safety or effectiveness (78 FR 34108).
tkelley on DSK3SPTVN1PROD with NOTICES

Congress enacted the Drug Price Product List’’ section of the Orange 2 On September 25, 2012, Reckitt submitted a
Competition and Patent Term Book. Another buprenorphine- citizen petition requesting that FDA not approve
Restoration Act of 1984 (Pub. L. 98–417) containing product, SUBOXONE any new drug application or abbreviated new drug
(the 1984 amendments), which (buprenorphine HCl and naloxone HCl) application (ANDA) for a buprenorphine product
for treatment of opioid dependence unless the
authorized the approval of duplicate Sublingual Tablets, is the subject of applications and products met certain criteria. On
versions of drug products under an NDA 20–733, also held by Reckitt. It February 22, 2013, FDA denied Reckitt’s petition
ANDA procedure. ANDA sponsors was originally approved on October 8, (Docket No. FDA–2012–P–1028).

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Document Created: 2015-12-18 13:17:44
Document Modified: 2015-12-18 13:17:44

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; correction.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 8087

80 FR 8087 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 30 (February 13, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration