81_FR_34451 81 FR 34347 - Determination That LEVOTHROID (Levothyroxine Sodium) Tablets, 0.025 Milligram, 0.05 Milligram, 0.075 Milligram, 0.088 Milligram, 0.112 Milligram, 0.125 Milligram, 0.137 Milligram, 0.15 Milligram, 0.175 Milligram, 0.1 Milligram, 0.2 Milligram, and 0.3 Milligram, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

81 FR 34347 - Determination That LEVOTHROID (Levothyroxine Sodium) Tablets, 0.025 Milligram, 0.05 Milligram, 0.075 Milligram, 0.088 Milligram, 0.112 Milligram, 0.125 Milligram, 0.137 Milligram, 0.15 Milligram, 0.175 Milligram, 0.1 Milligram, 0.2 Milligram, and 0.3 Milligram, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 104 (May 31, 2016)

Page Range34347-34348
FR Document2016-12655

The Food and Drug Administration (FDA or Agency) has determined that LEVOTHROID (levothyroxine sodium) tablets, 0.025 milligram (mg), 0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for LEVOTHROID (levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg, if all other legal and regulatory requirements are met.

Federal Register, Volume 81 Issue 104 (Tuesday, May 31, 2016)
[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34347-34348]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-12655]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-P-0403]


Determination That LEVOTHROID (Levothyroxine Sodium) Tablets, 
0.025 Milligram, 0.05 Milligram, 0.075 Milligram, 0.088 Milligram, 
0.112 Milligram, 0.125 Milligram, 0.137 Milligram, 0.15 Milligram, 
0.175 Milligram, 0.1 Milligram, 0.2 Milligram, and 0.3 Milligram, 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Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 or Agency) has 
determined that LEVOTHROID

[[Page 34348]]

(levothyroxine sodium) tablets, 0.025 milligram (mg), 0.05 mg, 0.075 
mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 
0.2 mg, and 0.3 mg, were not withdrawn from sale for reasons of safety 
or effectiveness. This determination will allow FDA to approve 
abbreviated new drug applications (ANDAs) for LEVOTHROID (levothyroxine 
sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125 
mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg, if all 
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Reena Raman, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6284, Silver Spring, MD 20993-0002, 301-
796-7577.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products under an ANDA procedure. ANDA applicants 
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. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA).
    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 known generally as the ``Orange 
Book.'' Under FDA regulations, drugs are 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).
    A person may petition the Agency to determine, or the Agency may 
determine on its own initiative, whether a listed drug was withdrawn 
from sale for reasons of safety or effectiveness. This determination 
may be made at any time after the drug has been withdrawn from sale, 
but must be made prior to approving an ANDA that refers to the listed 
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    LEVOTHROID (levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 
mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 
0.2 mg, and 0.3 mg, are the subject of NDA 021116, held by Lloyd Inc., 
and initially approved on October 24, 2002. LEVOTHROID is used for the 
following indications:
     Hypothyroidism--As replacement or supplemental therapy in 
congenital or acquired hypothyroidism of any etiology, except transient 
hypothyroidism during the recovery phase of subacute thyroiditis. 
Specific indications include: Primary (thyroidal), secondary 
(pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical 
hypothyroidism. Primary hypothyroidism may result from functional 
deficiency, primary atrophy, partial or total congenital absence of the 
thyroid gland, or from the effects of surgery, radiation, or drugs, 
with or without the presence of goiter.
     Pituitary Thyrotropine-Stimulating Hormone Suppression--In 
the treatment or prevention of various types of euthyroid goiters, 
including thyroid nodules, subacute or chronic lymphocytic thyroiditis 
(Hashimoto's thyroiditis), multinodular goiter, and as an adjunct to 
surgery and radioiodine therapy in the management of thyrotropin-
dependent well-differentiated thyroid cancer.
    LEVOTHROID (levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 
mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 
0.2 mg, and 0.3 mg are currently listed in the ``Discontinued Drug 
Product List'' section of the Orange Book.
    Lachman Consultant Services, Inc., submitted a citizen petition 
dated February 4, 2015 (Docket No. FDA-2015-P-0403), under 21 CFR 
10.30, requesting that the Agency determine whether LEVOTHROID 
(levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 
0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 
0.3 mg, were withdrawn from sale for reasons of safety or 
effectiveness.
    After considering the citizen petition and reviewing Agency records 
and based on the information we have at this time, FDA has determined 
under Sec.  314.161 that LEVOTHROID (levothyroxine sodium) tablets, 
0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 
0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg, were not withdrawn for 
reasons of safety or effectiveness. The petitioner has identified no 
data or other information suggesting that this drug product was 
withdrawn for reasons of safety or effectiveness. We have carefully 
reviewed our files for records concerning the withdrawal of LEVOTHROID 
(levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 
0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 
0.3 mg, from sale. We have also independently evaluated relevant 
literature and data for possible postmarketing adverse events. We have 
found no information that would indicate that this drug product was 
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list LEVOTHROID 
(levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 
0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 
0.3 mg, in the ``Discontinued Drug Product List'' section of the Orange 
Book. The ``Discontinued Drug Product List'' delineates, among other 
items, drug products that have been discontinued from marketing for 
reasons other than safety or effectiveness. ANDAs that refer to this 
drug product may be approved by the Agency as long as they meet all 
other legal and regulatory requirements for the approval of ANDAs. If 
FDA determines that labeling for this drug product should be revised to 
meet current standards, the Agency will advise ANDA applicants to 
submit such labeling.

    Dated: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12655 Filed 5-27-16; 8:45 am]
 BILLING CODE 4164-01-P



                                                                                          Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices                                                         34347

                                                                           TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR HUMAN DRUGS 1—Continued
                                                                                                                                                                 Number of                           Average bur-
                                                  E6(R2) Good Clinical Practice; International Council for                                    Number of                          Total annual
                                                                                                                                                                records per                          den per rec-   Total hours
                                                       Harmonisation; Draft Guidance for Industry                                           recordkeepers                          records
                                                                                                                                                               recordkeeper                           ordkeeping

                                                Developing a Quality Management System.
                                                   1 There     are no capital costs or operating and maintenance costs associated with this collection of information.

                                                                                           TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1
                                                                                                                                                              Number of re-                          Average bur-
                                                  E6(R2) Good Clinical Practice; International Council for                                  Number of re-                        Total annual
                                                                                                                                                               sponses per                            den per re-   Total hours
                                                       Harmonisation; Draft Guidance for Industry                                            spondents                            responses
                                                                                                                                                                respondent                              sponse

                                                Section 5.0.7—Risk Reporting .............................................                     1,457                  4.6           6,702                 3           20,107
                                                Describing the Quality Management Approach Imple-
                                                  mented in a Clinical Trial and Summarizing Important
                                                  Deviations From the Predefined Quality Tolerance Lim-
                                                  its in a Clinical Study Report.
                                                   1 There     are no capital costs or operating and maintenance costs associated with this collection of information.

                                                                                          TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS 1
                                                                                                                                                                 Number of
                                                  E6(R2) Good Clinical Practice; International Council for                                    Number of                                           Average bur-
                                                                                                                                                                records per      Total records                      Total hours
                                                       Harmonisation; Draft Guidance for Industry                                           recordkeepers                                        den per record
                                                                                                                                                               recordkeeper

                                                Section 5.0—Quality Management (including 5.0.1 to
                                                  5.0.7) ................................................................................       218                    1             218                 60           13,080
                                                Developing a Quality Management System.
                                                   1 There     are no capital costs or operating and maintenance costs associated with this collection of information.

                                                                                               TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS 1
                                                                                                                                                              Number of re-                          Average bur-
                                                  E6(R2) Good Clinical Practice; International Council for                                  Number of re-                        Total annual
                                                                                                                                                               sponses per                            den per re-   Total hours
                                                       Harmonisation; Draft Guidance for Industry                                             sponses                             responses
                                                                                                                                                                respondent                              sponse

                                                Section 5.0.7—Risk Reporting .............................................                      218                   3.69           804                  3           2,413
                                                Describing the Quality Management Approach Imple-
                                                  mented in a Clinical Trial and Summarizing Important
                                                  Deviations From the Predefined Quality Tolerance Lim-
                                                  its in a Clinical Study Report.
                                                   1 There     are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   The collections of information                                           Dated: May 24, 2016.                                   DEPARTMENT OF HEALTH AND
                                                included in the sections marked as                                        Leslie Kux,                                              HUMAN SERVICES
                                                ‘‘ADDENDUM’’ in the E6(R2) draft                                          Associate Commissioner for Policy.
                                                guidance also refers to previously                                                                                                 Food and Drug Administration
                                                                                                                          [FR Doc. 2016–12651 Filed 5–27–16; 8:45 am]
                                                approved collections of information                                       BILLING CODE 4164–01–P                                   [Docket No. FDA–2015–P–0403]
                                                found in FDA regulations. These
                                                collections of information are subject to                                                                                          Determination That LEVOTHROID
                                                review by OMB under the PRA. The                                                                                                   (Levothyroxine Sodium) Tablets, 0.025
                                                collections of information found in 21                                                                                             Milligram, 0.05 Milligram, 0.075
                                                CFR part 11 have been approved under                                                                                               Milligram, 0.088 Milligram, 0.112
                                                OMB control number 0910–0303; the                                                                                                  Milligram, 0.125 Milligram, 0.137
                                                collections of information found in 21                                                                                             Milligram, 0.15 Milligram, 0.175
                                                CFR part 312 have been approved under                                                                                              Milligram, 0.1 Milligram, 0.2 Milligram,
                                                OMB control number 0910–0014; and                                                                                                  and 0.3 Milligram, Were Not Withdrawn
                                                collections of information found in 21                                                                                             From Sale for Reasons of Safety or
                                                                                                                                                                                   Effectiveness
sradovich on DSK3TPTVN1PROD with NOTICES




                                                CFR part 314 have been approved under
                                                OMB control number 0910–0001. The                                                                                                  AGENCY:   Food and Drug Administration,
                                                collections of information found in 21                                                                                             HHS.
                                                CFR part 601 have been approved under                                                                                              ACTION:   Notice.
                                                OMB control number 0910–0338.
                                                                                                                                                                                   SUMMARY: The Food and Drug
                                                                                                                                                                                   Administration (FDA or Agency) has
                                                                                                                                                                                   determined that LEVOTHROID


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                                                34348                          Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices

                                                (levothyroxine sodium) tablets, 0.025                   FDA may not approve an ANDA that                      suggesting that this drug product was
                                                milligram (mg), 0.05 mg, 0.075 mg,                      does not refer to a listed drug.                      withdrawn for reasons of safety or
                                                0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg,                    LEVOTHROID (levothyroxine                          effectiveness. We have carefully
                                                0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and                  sodium) tablets, 0.025 mg, 0.05 mg,                   reviewed our files for records
                                                0.3 mg, were not withdrawn from sale                    0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg,               concerning the withdrawal of
                                                for reasons of safety or effectiveness.                 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2              LEVOTHROID (levothyroxine sodium)
                                                This determination will allow FDA to                    mg, and 0.3 mg, are the subject of NDA                tablets, 0.025 mg, 0.05 mg, 0.075 mg,
                                                approve abbreviated new drug                            021116, held by Lloyd Inc., and initially             0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg,
                                                applications (ANDAs) for LEVOTHROID                     approved on October 24, 2002.                         0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and
                                                (levothyroxine sodium) tablets, 0.025                   LEVOTHROID is used for the following                  0.3 mg, from sale. We have also
                                                mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112                  indications:                                          independently evaluated relevant
                                                mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175                     • Hypothyroidism—As replacement                    literature and data for possible
                                                mg, 0.1 mg, 0.2 mg, and 0.3 mg, if all                  or supplemental therapy in congenital                 postmarketing adverse events. We have
                                                other legal and regulatory requirements                 or acquired hypothyroidism of any                     found no information that would
                                                are met.                                                etiology, except transient                            indicate that this drug product was
                                                FOR FURTHER INFORMATION CONTACT:
                                                                                                        hypothyroidism during the recovery                    withdrawn from sale for reasons of
                                                                                                        phase of subacute thyroiditis. Specific               safety or effectiveness.
                                                Reena Raman, Center for Drug
                                                                                                        indications include: Primary (thyroidal),                Accordingly, the Agency will
                                                Evaluation and Research, Food and
                                                                                                        secondary (pituitary), and tertiary                   continue to list LEVOTHROID
                                                Drug Administration, 10903 New
                                                                                                        (hypothalamic) hypothyroidism and                     (levothyroxine sodium) tablets, 0.025
                                                Hampshire Ave., Bldg. 51, Rm. 6284,
                                                                                                        subclinical hypothyroidism. Primary                   mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112
                                                Silver Spring, MD 20993–0002, 301–
                                                                                                        hypothyroidism may result from                        mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175
                                                796–7577.
                                                                                                        functional deficiency, primary atrophy,               mg, 0.1 mg, 0.2 mg, and 0.3 mg, in the
                                                SUPPLEMENTARY INFORMATION: In 1984,                     partial or total congenital absence of the
                                                Congress enacted the Drug Price                                                                               ‘‘Discontinued Drug Product List’’
                                                                                                        thyroid gland, or from the effects of                 section of the Orange Book. The
                                                Competition and Patent Term                             surgery, radiation, or drugs, with or
                                                Restoration Act of 1984 (Pub. L. 98–417)                                                                      ‘‘Discontinued Drug Product List’’
                                                                                                        without the presence of goiter.                       delineates, among other items, drug
                                                (the 1984 amendments), which                               • Pituitary Thyrotropine-Stimulating
                                                authorized the approval of duplicate                                                                          products that have been discontinued
                                                                                                        Hormone Suppression—In the treatment
                                                versions of drug products under an                                                                            from marketing for reasons other than
                                                                                                        or prevention of various types of
                                                ANDA procedure. ANDA applicants                                                                               safety or effectiveness. ANDAs that refer
                                                                                                        euthyroid goiters, including thyroid
                                                must, with certain exceptions, show that                                                                      to this drug product may be approved
                                                                                                        nodules, subacute or chronic
                                                the drug for which they are seeking                                                                           by the Agency as long as they meet all
                                                                                                        lymphocytic thyroiditis (Hashimoto’s
                                                approval contains the same active                                                                             other legal and regulatory requirements
                                                                                                        thyroiditis), multinodular goiter, and as
                                                ingredient in the same strength and                                                                           for the approval of ANDAs. If FDA
                                                                                                        an adjunct to surgery and radioiodine
                                                dosage form as the ‘‘listed drug,’’ which               therapy in the management of                          determines that labeling for this drug
                                                is a version of the drug that was                       thyrotropin-dependent well-                           product should be revised to meet
                                                previously approved. ANDA applicants                    differentiated thyroid cancer.                        current standards, the Agency will
                                                do not have to repeat the extensive                        LEVOTHROID (levothyroxine                          advise ANDA applicants to submit such
                                                clinical testing otherwise necessary to                 sodium) tablets, 0.025 mg, 0.05 mg,                   labeling.
                                                gain approval of a new drug application                 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg,                 Dated: May 24, 2016.
                                                (NDA).                                                  0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2              Leslie Kux,
                                                   The 1984 amendments include what                     mg, and 0.3 mg are currently listed in                Associate Commissioner for Policy.
                                                is now section 505(j)(7) of the Federal                 the ‘‘Discontinued Drug Product List’’                [FR Doc. 2016–12655 Filed 5–27–16; 8:45 am]
                                                Food, Drug, and Cosmetic Act (21 U.S.C.                 section of the Orange Book.                           BILLING CODE 4164–01–P
                                                355(j)(7)), which requires FDA to                          Lachman Consultant Services, Inc.,
                                                publish a list of all approved drugs.                   submitted a citizen petition dated
                                                FDA publishes this list as part of the                  February 4, 2015 (Docket No. FDA–                     DEPARTMENT OF HEALTH AND
                                                ‘‘Approved Drug Products With                           2015–P–0403), under 21 CFR 10.30,                     HUMAN SERVICES
                                                Therapeutic Equivalence Evaluations,’’                  requesting that the Agency determine
                                                which is known generally as the                         whether LEVOTHROID (levothyroxine                     Food and Drug Administration
                                                ‘‘Orange Book.’’ Under FDA regulations,                 sodium) tablets, 0.025 mg, 0.05 mg,
                                                drugs are removed from the list if the                                                                        [Docket No. FDA–2016–N–0001]
                                                                                                        0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg,
                                                Agency withdraws or suspends                            0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2              Clinical Trial Design Considerations
                                                approval of the drug’s NDA or ANDA                      mg, and 0.3 mg, were withdrawn from                   for Malaria Drug Development; Notice
                                                for reasons of safety or effectiveness or               sale for reasons of safety or                         of Public Workshop; Correction
                                                if FDA determines that the listed drug                  effectiveness.
                                                was withdrawn from sale for reasons of                     After considering the citizen petition             AGENCY:   Food and Drug Administration,
                                                safety or effectiveness (21 CFR 314.162).               and reviewing Agency records and                      HHS.
                                                   A person may petition the Agency to                  based on the information we have at this              ACTION:   Notice; correction.
                                                determine, or the Agency may                            time, FDA has determined under
                                                determine on its own initiative, whether                § 314.161 that LEVOTHROID                             SUMMARY:   The Food and Drug
sradovich on DSK3TPTVN1PROD with NOTICES




                                                a listed drug was withdrawn from sale                   (levothyroxine sodium) tablets, 0.025                 Administration (FDA) is correcting a
                                                for reasons of safety or effectiveness.                 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112                notice that appeared in the Federal
                                                This determination may be made at any                   mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175                Register of Tuesday, May 10, 2016 (81
                                                time after the drug has been withdrawn                  mg, 0.1 mg, 0.2 mg, and 0.3 mg, were                  FR 28876). The document announced a
                                                from sale, but must be made prior to                    not withdrawn for reasons of safety or                public workshop entitled ‘‘Clinical Trial
                                                approving an ANDA that refers to the                    effectiveness. The petitioner has                     Design Considerations for Malaria Drug
                                                listed drug (§ 314.161 (21 CFR 314.161)).               identified no data or other information               Development.’’ The document was


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Document Created: 2016-05-28 03:57:38
Document Modified: 2016-05-28 03:57:38
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactReena Raman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6284, Silver Spring, MD 20993-0002, 301- 796-7577.
FR Citation81 FR 34347 

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