Determination That BENADRYL (diphenhydramine hydrochloride) Injection and Two Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 17933-17934 [2013-06726]

Download as PDF 17933 Federal Register / Vol. 78, No. 57 / Monday, March 25, 2013 / Notices ‘‘[a]nalysis of the sample may be performed for the plant by competent commercial laboratories (e.g., Environmental Protection Agency (EPA) and State-certified laboratories)’’ (§ 129.35(a)(3)(iii)). For product water, the regulations also state that bottled water manufacturers will ‘‘[a]nalyze such samples by methods approved by the government agency or agencies having jurisdiction’’ (§ 129.80(g)(3)). One comment noted that the EPA issued a final rule on February 13, 2013, that established a maximum contaminant level for E. coli and stated that E. coli is a more specific indicator of fecal contamination and the potential presence of associated pathogen occurrence than fecal coliforms. FDA agrees that E. coli is an appropriate indicator of fecal contamination and that the presence of fecal indicators demonstrates the potential for the presence of fecal pathogens. FDA requires bottled water manufacturers to sample and analyze source water obtained from other than a public water system for total coliform at least once each week. If any coliform organisms are detected, manufacturers must conduct followup testing to determine whether any of the coliform organisms are E. coli. Source water found to contain E. coli is not considered water of a safe, sanitary quality as required for use in bottled water. Manufacturers must also analyze product water samples at least once a week for total coliform, and, if any coliform organisms are detected, they must conduct followup testing to determine whether any of the coliform organisms are E. coli. Product water containing E. coli is considered adulterated. Thus, the presence of the fecal indicator E. coli is the key factor for determining whether source water is of a safe, sanitary quality, and whether product water is adulterated. FDA is reviewing the EPA final rule referenced in the comment (National Primary Drinking Water Regulations: Revisions to the Total Coliform Rule, 78 FR 10269; February 13, 2013) to determine what actions, if any, FDA needs to take to respond to the rule. To the extent that the comments recommended changes to FDA’s bottled water regulations, which can only be accomplished by rulemaking, the comments were outside the scope of the four collection of information topics on which the notice requested comments and will not be discussed in this document. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 Number of records per recordkeeper Total annual records Average burden per recordkeeping 21 CFR Section Number of recordkeepers §§ 129.35(a)(3)(i) and 129.80(h) ...... 6 1,914 0.08 (5 minutes) 153 3 285 0.08 (5 minutes) 23 5 15 0.08 (5 minutes) 1 §§ 129.35(a)(3)(i) and 129.80(h) ...... 319 (bottlers subject to source water and finished product testing). 95 (bottlers testing finished product only). 3 (bottlers conducting secondary testing of source water). 3 (bottlers rectifying contamination) 3 9 0.25 (15 minutes) 2 Total .......................................... .......................................................... ........................ ........................ § 129.80(g) and 129.80(h) ............... §§ 129.35(a)(3)(i) and 129.80(h) ...... mstockstill on DSK4VPTVN1PROD with NOTICES 1 There Total hours 179 are no capital costs or operating and maintenance costs associated with this collection of information. The current CGMP regulations already reflect the time and associated recordkeeping costs for those bottlers that are required to conduct microbiological testing of their source water, as well as total coliform testing of their finished bottled water products. We therefore conclude that any additional burden and costs in recordkeeping based on followup testing that is required if any coliform organisms detected in the source water test positive for E.coli are negligible. We estimate that the labor burden of keeping records of each test is about 5 minutes per test. We also require followup testing of source water and finished bottled water products for E. coli when total coliform positives occur. We expect that 319 bottlers that use sources other than PWSs may find a total coliform positive sample about 3 times per year in source testing and about 3 times in finished product testing, for a total of 153 hours of recordkeeping. In addition to the 319 bottlers, about 95 bottlers that use PWSs VerDate Mar<15>2010 17:34 Mar 22, 2013 Jkt 229001 may find a total coliform positive sample about 3 times per year in finished product testing, for a total of 23 hours of recordkeeping. Upon finding a total coliform sample, bottlers will then have to conduct a followup test for E. coli. We expect that recordkeeping for the followup test for E. coli will also take about 5 minutes per test. As shown in table 1 of this document, we expect that 3 bottlers per year will have to carry out the additional E. coli testing, with a burden of 1 hour. These bottlers will also have to keep records about rectifying the source contamination, for a burden of 2 hours. For all expected total coliform testing, E. coli testing, and source rectification, we estimate a total burden of 179 hours. We base our estimate on our experience with the current CGMP regulations. PO 00000 Dated: March 20, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–06727 Filed 3–22–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0320] Determination That BENADRYL (diphenhydramine hydrochloride) Injection and Two Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined that the three drug products listed in this document were not withdrawn from SUMMARY: Frm 00014 Fmt 4703 Sfmt 4703 E:\FR\FM\25MRN1.SGM 25MRN1 17934 Federal Register / Vol. 78, No. 57 / Monday, March 25, 2013 / Notices sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Mark Geanacopoulos, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD 20993–0002, 301– 796–6925. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA sponsors must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. Sponsors of ANDAs do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is generally known as the ‘‘Orange Book.’’ Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug. FDA has become aware that the drug products listed in the table in this document are no longer being marketed. Application No. Drug Applicant NDA 006146 ...... BENADRYL (diphenhydramine hydrochloride) Injection, 50 milligrams (mg)/milliliter (mL). BENADRYL PRESERVATIVE FREE (diphenhydramine hydrochloride) Injection, 50 mg/mL. FLEXERIL (cyclobenzaprine hydrochloride) Tablets, 5 mg and 10 mg. McNeil Consumer Healthcare, 7050 Camp Hill Rd., Fort Washington, PA 19034. Do. NDA 009486 ...... mstockstill on DSK4VPTVN1PROD with NOTICES NDA 017821 ...... FDA has reviewed its records and, under § 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products listed in this document in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. Approved ANDAs that refer to the NDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. VerDate Mar<15>2010 17:34 Mar 22, 2013 Jkt 229001 Janssen Research & Development, LLC, 920 Rt. 202, Raritan, NJ 08869. Dated: March 19, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–06726 Filed 3–22–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Standardized Medical Device Labeling.’’ The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. DATES: Submit either electronic or written comments by May 17, 2013. ADDRESSES: You may submit comments, identified by Docket No. FDA–2012–N– 1205, by any of the following methods: Electronic Submissions [Docket No. FDA–2012–N–1205] Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Notice of public workshop; request for comments; extension of comment period. ACTION: The Food and Drug Administration (FDA) is extending the comment period for the notice that appeared in the Federal Register of January 7, 2013 (78 FR 951). In the notice, FDA requested comments on the public workshop entitled ‘‘Accessible SUMMARY: PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Written Submissions Submit written submissions in the following ways: • Mail/Hand delivery/Courier (for paper or CD–ROM submissions): Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the agency name and Docket No. FDA–2012–N–1205. All comments received may be posted E:\FR\FM\25MRN1.SGM 25MRN1

Agencies

[Federal Register Volume 78, Number 57 (Monday, March 25, 2013)]
[Notices]
[Pages 17933-17934]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06726]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0320]


Determination That BENADRYL (diphenhydramine hydrochloride) 
Injection and Two Other Drug Products Were Not Withdrawn From Sale for 
Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined that the 
three drug products listed in this document were not withdrawn from

[[Page 17934]]

sale for reasons of safety or effectiveness. This determination means 
that FDA will not begin procedures to withdraw approval of abbreviated 
new drug applications (ANDAs) that refer to these drug products, and it 
will allow FDA to continue to approve ANDAs that refer to the products 
as long as they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT:  Mark Geanacopoulos, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 301-
796-6925.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products approved under an ANDA procedure. ANDA 
sponsors must, with certain exceptions, show that the drug for which 
they are seeking approval contains the same active ingredient in the 
same strength and dosage form as the ``listed drug,'' which is a 
version of the drug that was previously approved. Sponsors of ANDAs do 
not have to repeat the extensive clinical testing otherwise necessary 
to gain approval of a new drug application (NDA). The only clinical 
data required in an ANDA are data to show that the drug that is the 
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 
requires FDA to publish a list of all approved drugs. FDA publishes 
this list as part of the ``Approved Drug Products With Therapeutic 
Equivalence Evaluations,'' which is generally known as the ``Orange 
Book.'' Under FDA regulations, a drug is removed from the list if the 
Agency withdraws or suspends approval of the drug's NDA or ANDA for 
reasons of safety or effectiveness, or if FDA determines that the 
listed drug was withdrawn from sale for reasons of safety or 
effectiveness (21 CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must 
determine whether a listed drug was withdrawn from sale for reasons of 
safety or effectiveness: (1) Before an ANDA that refers to that listed 
drug may be approved, (2) whenever a listed drug is voluntarily 
withdrawn from sale and ANDAs that refer to the listed drug have been 
approved, and (3) when a person petitions for such a determination 
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if 
FDA determines that a listed drug was withdrawn from sale for safety or 
effectiveness reasons, the Agency will initiate proceedings that could 
result in the withdrawal of approval of the ANDAs that refer to the 
listed drug.
    FDA has become aware that the drug products listed in the table in 
this document are no longer being marketed.

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 006146.............  BENADRYL                 McNeil Consumer
                          (diphenhydramine         Healthcare, 7050 Camp
                          hydrochloride)           Hill Rd., Fort
                          Injection, 50            Washington, PA 19034.
                          milligrams (mg)/
                          milliliter (mL).
NDA 009486.............  BENADRYL PRESERVATIVE    Do.
                          FREE (diphenhydramine
                          hydrochloride)
                          Injection, 50 mg/mL.
NDA 017821.............  FLEXERIL                 Janssen Research &
                          (cyclobenzaprine         Development, LLC, 920
                          hydrochloride)           Rt. 202, Raritan, NJ
                          Tablets, 5 mg and 10     08869.
                          mg.
------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has 
determined that the drug products listed in this document were not 
withdrawn from sale for reasons of safety or effectiveness. 
Accordingly, the Agency will continue to list the drug products listed 
in this document in the ``Discontinued Drug Product List'' section of 
the Orange Book. The ``Discontinued Drug Product List'' identifies, 
among other items, drug products that have been discontinued from 
marketing for reasons other than safety or effectiveness.
    Approved ANDAs that refer to the NDAs listed in this document are 
unaffected by the discontinued marketing of the products subject to 
those NDAs. Additional ANDAs that refer to these products may also be 
approved by the Agency if they comply with relevant legal and 
regulatory requirements. If FDA determines that labeling for these drug 
products should be revised to meet current standards, the Agency will 
advise ANDA applicants to submit such labeling.

    Dated: March 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06726 Filed 3-22-13; 8:45 am]
BILLING CODE 4160-01-P