82 FR 7837 - Determination That ACTHAR GEL SYNTHETIC (Seractide Acetate) Injection, 80 Units/Milliliter and 40 Units/Milliliter, Was Withdrawn From Sale for Reasons of Safety or Effectiveness
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 13 (January 23, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 13 (January 23, 2017)
| Page Range | 7837-7839 | |
| FR Document | 2017-01249 |
[Federal Register Volume 82, Number 13 (Monday, January 23, 2017)] [Notices] [Pages 7837-7839] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-01249] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-P-0377] Determination That ACTHAR GEL SYNTHETIC (Seractide Acetate) Injection, 80 Units/Milliliter and 40 Units/Milliliter, Was Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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 we) has determined that ACTHAR GEL SYNTHETIC (seractide acetate) injection, 80 units/ milliliter (mL) and 40 units/mL, was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for seractide acetate injection, 80 units/mL and 40 units/mL. FOR FURTHER INFORMATION CONTACT: David E. Markert, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301- 796-0752. SUPPLEMENTARY INFORMATION: I. Background 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 (21 CFR 314.161). FDA may not approve an ANDA that does not refer to a listed drug. ACTHAR GEL SYNTHETIC (seractide acetate) injection, 80 units/mL and 40 units/mL was the subject of NDA 017861, which was held by Armour Pharmaceutical Co. (Armour), and initially approved on February 21, 1978. ACTHAR GEL SYNTHETIC is indicated for diagnostic testing of adrenocortical function. The labeling also provides that ACTHAR GEL SYNTHETIC may be employed in the following disorders: Endocrine Disorders: Nonsuppurative thyroiditis; Hypercalcemia associated with cancer. Nervous System Diseases: Acute exacerbations of multiple sclerosis. Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis; rheumatoid arthritis, including juvenile [[Page 7838]] rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute non-specific tenosynovitis; acute gouty arthritis; post-traumatic arthritis; synovitis of osteoarthritis; epicondylitis. Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus; systemic dermatomyositis (polymyositis); acute rheumatic carditis. Dermatologic Diseases: Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; severe psoriasis; severe seborrheic dermatitis; mycosis fungoides. Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment-- seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness. Ophthalmic Diseases: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic conjunctivitis; keratitis; herpes zoster ophthalmicus; iritis and iridocyclitis; diffuse posterior uveitis and choroiditis; optic neuritis; sympathetic ophthalmia; chorioretinitis; anterior segment inflammation; allergic corneal marginal ulcers. Respiratory Diseases: Symptomatic sarcoidosis; Loeffler's syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with anti-tuberculous chemotherapy; aspiration pneumonitis. Hematologic Disorders: Acquired (autoimmune) hemolytic anemia; secondary thrombocytopenia in adults; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic Diseases: For palliative management of: Leukemias and lymphomas in adults; acute leukemia of childhood. Edematous State: To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases: To tide the patient over a critical period of the disease in: Ulcerative colitis; regional enteritis. Miscellaneous: Tuberculous meningitis with subarachnoid block or impending block when concurrently accompanied by appropriate anti- tuberculous chemotherapy; trichinosis with neurologic or myocardial involvement. Armour never marketed ACTHAR GEL SYNTHETIC (seractide acetate) injection, 80 units/mL and 40 units/mL. In previous instances (see, e.g., 72 FR 9763, March 5, 2007 and 61 FR 25497, May 21, 1996), the Agency has determined that for purposes of Sec. Sec. 314.161 and 314.162, never marketing an approved drug product is equivalent to withdrawing the drug from sale. FDA withdrew approval of the NDA for ACTHAR GEL SYNTHETIC in 2014 because Armour had repeatedly failed to file annual reports for the application (79 FR 68454, November 17, 2014). Hyman, Phelps & McNamara, P.C., submitted a citizen petition dated April 1, 2014 (Docket No. FDA-2014-P-0377), under 21 CFR 10.30, requesting that the Agency determine whether ACTHAR GEL SYNTHETIC (seractide acetate) injection, 80 units/mL and 40 units/mL, was withdrawn from sale for reasons of safety or effectiveness. II. Response to Citizen Petition We have carefully reviewed the citizen petition (and comments submitted to the docket); our records for ACTHAR GEL SYNTHETIC (seractide acetate) injection, 80 units/mL and 40 units/mL; the scientific literature on seractide acetate; and other relevant information. Based on that review, and for the reasons set forth in this section, we have concluded that additional studies of safety would be necessary before ACTHAR GEL SYNTHETIC could be considered for introduction to the market today. Consequently, FDA has determined under Sec. 314.161 that ACTHAR GEL SYNTHETIC (seractide acetate) injection, 80 units/mL and 40 units/mL, was withdrawn for reasons of safety.\1\ --------------------------------------------------------------------------- \1\ In light of this conclusion, it is unnecessary for us to determine whether ACTHAR GEL SYNTHETIC was also withdrawn from sale for reasons of effectiveness. This notice does not address the effectiveness of ACTHAR GEL SYNTHETIC for its labeled indications. --------------------------------------------------------------------------- The labeling for ACTHAR GEL SYNTHETIC describes the product as ``a highly purified synthetic polypeptide containing thirty-nine amino acids in the sequence described for human corticotropin by Lee, T.H.; Lerner, A.B.; and Buettner-Janusch, Vina (J. Biol Chem, 236:2970-2974, Nov. 1961)'' (Refs. 1 and 2). At the time of ACTHAR GEL SYNTHETIC's approval, FDA believed the amino acid sequence described by Lee et al. was the correct sequence for human corticotropin and, therefore, that ACTHAR GEL SYNTHETIC was identical to human corticotropin.\2\ However, since approval, the Agency has learned that ACTHAR GEL SYNTHETIC is not identical to the human corticotropin sequence. We now know that the amino acid sequence described by Lee et al. is a deamidated version of human corticotropin that differs from full length human corticotropin at four positions.\3\ --------------------------------------------------------------------------- \2\ The Agency's Institutional Summary of Basis of Approval (Ref. 3) describes ACTHAR GEL SYNTHETIC as ``a synthetic peptide of 39 amino acids identical with that of natural human'' corticotropin. \3\ The record for human pro-opiomelanocortin preproprotein in the National Center for Biotechnology Information's ``Protein'' database (Reference Sequence NP_000930.1) contains the correct amino acid sequence for human corticotropin. The record is available at the following URL: https://www.ncbi.nlm.nih.gov/protein/NP_000930.1. The sequence described by Lee et al. differs from the correct sequence at positions 25-27 and 30. --------------------------------------------------------------------------- The fact that ACTHAR GEL SYNTHETIC has a different amino acid sequence from human corticotropin raises significant safety concerns. Due to its different amino acid sequence, ACTHAR GEL SYNTHETIC might have a structure or function that is not recognized as endogenous by the immune system. ACTHAR GEL SYNTHETIC thus poses a higher risk of immunogenicity than a synthetic peptide product that is, in fact, identical to human corticotropin. The health consequences of immunogenicity range from subacute, minor reactions to severe, even deadly, reactions (e.g., anaphylaxis). In addition, frequent stimulation of the immune system could produce antibodies that cross- react with human corticotropin and other closely related endogenous peptides, resulting in the loss of those peptides' physiological functions. Such an effect could last long after treatment with ACTHAR GEL SYNTHETIC has stopped. The safety concerns noted in this section have not been adequately investigated. ACTHAR GEL SYNTHETIC was studied in two clinical trials in 51 healthy adult men between 21 and 54 years old. Although no unusual adverse effects were reported during these trials, the trials did not assess the impact of immunogenicity on safety. Nor were they designed to assess immunogenicity. Moreover, because ACTHAR GEL SYNTHETIC was never marketed, the Agency has no postmarketing safety data or information confirming that the product is safe for human use, notwithstanding the differences between ACTHAR GEL SYNTHETIC's amino acid sequence and that of human corticotropin. Given the lack of any premarket or postmarket [[Page 7839]] immunogenicity safety data, FDA cannot conclude that ACTHAR GEL SYNTHETIC would be safe for human use if it were introduced to the market today. Accordingly, the Agency will remove ACTHAR GEL SYNTHETIC (seractide acetate) injection, 80 units/mL and 40 units/mL, from the list of drug products published in the Orange Book. FDA will not accept or approve ANDAs that refer to this drug product. III. References The following references have 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 are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. 1. Armour Pharmaceutical Co., ``ACTHAR[supreg] Gel Synthetic (SERACTIDE ACETATE), Synthetic Corticotropin,'' Product Labeling, 1979. 2. Lee, T. H., A. B. Lerner, and V. Buettner-Janusch, ``On the Structure of Human Corticotropin (Adrenocorticotropic Hormone),'' The Journal of Biological Chemistry, vol. 236, pp. 2970-2974, 1961. 3. FDA, ``Seractide Acetate: Institutional Summary of Basis of Approval,'' August 22, 1977. Dated: January 13, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-01249 Filed 1-19-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices 7837
• Ensure adequate and timely Tribal HV Form 2 will provide a Respondents: Tribal Maternal, Infant,
reporting of program data to relevant template for Tribal MIECHV grantees to and Early Childhood Home Visiting
federal agencies and stakeholders report data on their progress under the Program Grantees.
including the Congress, and members of six benchmark areas as stipulated in
the public. legislation.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
Tribal Maternal, Infant, and Early Childhood Home Visiting Performance Re-
porting Form ................................................................................................. 20 1 500 10,000
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND clinical testing otherwise necessary to
Hours: 10,000. HUMAN SERVICES gain approval of a new drug application
In compliance with the requirements (NDA).
Food and Drug Administration The 1984 amendments include what
of Section 3506(c)(2)(A) of the
is now section 505(j)(7) of the Federal
Paperwork Reduction Act of 1995, the [Docket No. FDA–2014–P–0377]
Food, Drug, and Cosmetic Act (21 U.S.C.
Administration for Children and
Determination That ACTHAR GEL 355(j)(7)), which requires FDA to
Families is soliciting public comment
SYNTHETIC (Seractide Acetate) publish a list of all approved drugs.
on the specific aspects of the FDA publishes this list as part of the
Injection, 80 Units/Milliliter and 40
information collection described above. ‘‘Approved Drug Products With
Units/Milliliter, Was Withdrawn From
Copies of the proposed collection of Therapeutic Equivalence Evaluations,’’
Sale for Reasons of Safety or
information can be obtained and which is known generally as the
Effectiveness
comments may be forwarded by writing ‘‘Orange Book.’’ Under FDA regulations,
to the Administration for Children and AGENCY: Food and Drug Administration, drugs are removed from the list if the
Families, Office of Planning, Research HHS. Agency withdraws or suspends
and Evaluation, 330 C St. SW., ACTION: Notice. approval of the drug’s NDA or ANDA
Washington, DC 20201, Attn: OPRE for reasons of safety or effectiveness or
Reports Clearance Officer. Email SUMMARY: The Food and Drug if FDA determines that the listed drug
address: OPREinfocollection@ Administration (FDA or we) has was withdrawn from sale for reasons of
acf.hhs.gov. All requests should be determined that ACTHAR GEL safety or effectiveness (21 CFR 314.162).
identified by the title of the information SYNTHETIC (seractide acetate) A person may petition the Agency to
collection. injection, 80 units/milliliter (mL) and 40 determine, or the Agency may
units/mL, was withdrawn from sale for determine on its own initiative, whether
The Department specifically requests reasons of safety or effectiveness. The a listed drug was withdrawn from sale
comments on: (a) Whether the proposed Agency will not accept or approve for reasons of safety or effectiveness.
collection of information is necessary abbreviated new drug applications This determination may be made at any
for the proper performance of the (ANDAs) for seractide acetate injection, time after the drug has been withdrawn
functions of the agency, including 80 units/mL and 40 units/mL. from sale, but must be made prior to
whether the information shall have FOR FURTHER INFORMATION CONTACT: approving an ANDA that refers to the
practical utility; (b) the accuracy of the David E. Markert, Center for Drug listed drug (21 CFR 314.161). FDA may
agency’s estimate of the burden of the Evaluation and Research, Food and not approve an ANDA that does not
proposed collection of information; (c) Drug Administration, 10903 New refer to a listed drug.
the quality, utility, and clarity of the Hampshire Ave., Bldg. 51, Rm. 6222, ACTHAR GEL SYNTHETIC (seractide
information to be collected; and (d) Silver Spring, MD 20993–0002, 301– acetate) injection, 80 units/mL and 40
ways to minimize the burden of the 796–0752. units/mL was the subject of NDA
collection of information on SUPPLEMENTARY INFORMATION: 017861, which was held by Armour
respondents, including through the use Pharmaceutical Co. (Armour), and
of automated collection techniques or I. Background initially approved on February 21, 1978.
other forms of information technology. In 1984, Congress enacted the Drug ACTHAR GEL SYNTHETIC is indicated
Consideration will be given to Price Competition and Patent Term for diagnostic testing of adrenocortical
comments and suggestions submitted Restoration Act of 1984 (Pub. L. 98–417) function. The labeling also provides that
within 60 days of this publication. (the 1984 amendments), which ACTHAR GEL SYNTHETIC may be
authorized the approval of duplicate employed in the following disorders:
Mary Jones, versions of drug products under an Endocrine Disorders: Nonsuppurative
ACF/OPRE Certifying Officer. ANDA procedure. ANDA applicants thyroiditis; Hypercalcemia associated
must, with certain exceptions, show that with cancer.
mstockstill on DSK3G9T082PROD with NOTICES
[FR Doc. 2017–01276 Filed 1–19–17; 8:45 am]
BILLING CODE 4184–01–P the drug for which they are seeking Nervous System Diseases: Acute
approval contains the same active exacerbations of multiple sclerosis.
ingredient in the same strength and Rheumatic Disorders: As adjunctive
dosage form as the ‘‘listed drug,’’ which therapy for short-term administration (to
is a version of the drug that was tide the patient over an acute episode or
previously approved. ANDA applicants exacerbation) in: Psoriatic arthritis;
do not have to repeat the extensive rheumatoid arthritis, including juvenile
VerDate Sep<11>2014 19:02 Jan 19, 2017 Jkt 241001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\23JAN1.SGM 23JAN1](https://thefederalregister.org/doc/82_FR_7850/page/1.svg)
![Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices 7839
immunogenicity safety data, FDA ADDRESSES: To ensure that comments on determines substantial equivalence after
cannot conclude that ACTHAR GEL the information collection are received, reviewing an applicant’s premarket
SYNTHETIC would be safe for human OMB recommends that written notification submitted in accordance
use if it were introduced to the market comments be faxed to the Office of with section 510(k) of the FD&C Act (21
today. Information and Regulatory Affairs, U.S.C. 360(k)). Postamendments devices
Accordingly, the Agency will remove OMB, Attn: FDA Desk Officer, FAX: determined by FDA to be not
ACTHAR GEL SYNTHETIC (seractide 202–395–7285, or emailed to oira_ substantially equivalent to either
acetate) injection, 80 units/mL and 40 submission@omb.eop.gov. All preamendments devices or
units/mL, from the list of drug products comments should be identified with the postamendments devices classified into
published in the Orange Book. FDA will OMB control number 0910–0231. Also class I or II are ‘‘new’’ devices and fall
not accept or approve ANDAs that refer include the FDA docket number found automatically into class III. Before such
to this drug product. in brackets in the heading of this devices can be marketed, they must
III. References document. have an approved PMA application or
FOR FURTHER INFORMATION CONTACT: FDA be must reclassified into class I or class
The following references have been II.
placed on display in the Division of PRA Staff, Office of Operations, Food
and Drug Administration, Three White The Food and Drug Modernization
Dockets Management (HFA–305), Food Act of 1997 (FDAMA) (Pub. L. 105–115)
and Drug Administration, 5630 Fishers Flint North 10A63, 11601 Landsdown
St., North Bethesda, MD 20852, was enacted on November 21, 1997, to
Lane, Rm. 1061, Rockville, MD 20852,
PRAStaff@fda.hhs.gov. implement revisions to the FD&C Act by
and are available for viewing by
SUPPLEMENTARY INFORMATION: In
streamlining the process of bringing safe
interested persons between 9 a.m. and 4
compliance with 44 U.S.C. 3507, FDA and effective drugs, medical devices,
p.m., Monday through Friday; they are
has submitted the following proposed and other therapies to the U.S. market.
also available electronically at https://
collection of information to OMB for FDAMA added section 515(d)(6) to the
www.regulations.gov.
review and clearance. FD&C Act (21 U.S.C. 360e(d)(6)), which
1. Armour Pharmaceutical Co., ‘‘ACTHAR® provided that PMA supplements were
Gel Synthetic (SERACTIDE ACETATE), Premarket Approval of Medical required for all device changes that
Synthetic Corticotropin,’’ Product Devices—OMB Control Number 0910–
Labeling, 1979.
affect safety and effectiveness unless
2. Lee, T. H., A. B. Lerner, and V. Buettner- 0231—Extension such changes are modifications to
Janusch, ‘‘On the Structure of Human Under section 515 of the Federal manufacturing procedures or method of
Corticotropin (Adrenocorticotropic Food, Drug, and Cosmetic Act (the manufacture. That type of
Hormone),’’ The Journal of Biological FD&C Act) (21 U.S.C. 360e) all devices manufacturing change will require a 30-
Chemistry, vol. 236, pp. 2970–2974, day notice, or where FDA finds such
1961.
placed into class III by FDA are subject
to premarket approval (PMA) notice inadequate, a 135-day PMA
3. FDA, ‘‘Seractide Acetate: Institutional
requirements. PMA is the process of supplement.
Summary of Basis of Approval,’’ August
22, 1977. scientific and regulatory review to The implementing regulations,
ensure the safety and effectiveness of contained in part 814 (21 CFR part 814),
Dated: January 13, 2017.
class III devices. An approved PMA is, further specify the contents of a PMA
Leslie Kux, for a medical device and the criteria
in effect, a private license granted to the
Associate Commissioner for Policy. FDA will employ in approving, denying,
applicant for marketing a particular
[FR Doc. 2017–01249 Filed 1–19–17; 8:45 am] or withdrawing approval of a PMA and
medical device. A class III device that
BILLING CODE 4164–01–P
fails to meet PMA requirements is supplements to PMAs. The regulations’
considered to be adulterated under purpose is to establish an efficient and
section 501(f) of the FD&C Act (21 thorough procedure for FDA’s review of
DEPARTMENT OF HEALTH AND PMAs and supplements to PMAs for
U.S.C. 351(f)) and cannot be marketed.
HUMAN SERVICES class III medical devices. The
PMA requirements apply differently to
preamendments devices, regulations facilitate the approval of
Food and Drug Administration
postamendments devices, and PMAs and supplements to PMAs for
[Docket No. FDA–2013–N–0825] transitional class III devices. devices that have been shown to be
Manufacturers of class III reasonably safe and effective and
Agency Information Collection preamendments devices, devices that otherwise meet the statutory criteria for
Activities; Submission for Office of were in commercial distribution before approval. The regulations also ensure
Management and Budget Review; May 28, 1976, are not required to submit the denial of PMAs and supplements to
Comment Request; Premarket a PMA until 30 months after the PMAs for devices that have not been
Approval of Medical Devices issuance of a final classification shown to be reasonably safe and
AGENCY: Food and Drug Administration, regulation or until 90 days after the effective and that do not otherwise meet
HHS. publication of a final regulation the statutory criteria for approval.
ACTION: Notice. requiring the submission of a PMA, The industry-wide burden estimate
whichever period is later. FDA may for PMAs is based on an FDA average
SUMMARY: The Food and Drug allow more than 90 days after issuance fiscal year (FY) annual rate of receipt of
Administration (FDA) is announcing of a final rule for submission of a PMA. PMA submissions data FYs 2013
that a proposed collection of A postamendments device is one that through 2015 and our expectation of
mstockstill on DSK3G9T082PROD with NOTICES
information has been submitted to the was first distributed commercially on or submissions to come in the next few
Office of Management and Budget after May 28, 1976. Postamendments years. The burden data for PMAs is
(OMB) for review and clearance under devices determined by FDA to be based on data provided by applicants by
the Paperwork Reduction Act of 1995. substantially equivalent to device type and cost element in an
DATES: Fax written comments on the preamendments class III devices are earlier study.
collection of information by February subject to the same requirements as the Reporting Burden: The reporting
22, 2017. preamendments devices. FDA burden can be broken out by certain
VerDate Sep<11>2014 19:02 Jan 19, 2017 Jkt 241001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\23JAN1.SGM 23JAN1](https://thefederalregister.org/doc/82_FR_7850/page/3.svg)
Document Created: 2017-01-20 01:29:52
Document Modified: 2017-01-20 01:29:52
| 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. | |
| Contact | David E. Markert, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301- 796-0752. | |
| FR Citation | 82 FR 7837 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR