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Federal Register / Vol. 86, No. 104 / Wednesday, June 2, 2021 / Notices
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 505j7 of the Federal Food, Drug, and Cosmetic Act 21 U.S.C.
355j7, 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 drugs 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for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness 21 CFR 314.162.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may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness.
This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug 314.161 21 CFR 314.161.
FDA may not approve an ANDA that does not refer to a listed drug.
SANDOSTATIN octreotide acetate injection, EQ 0.2 mg base/mL and EQ 1
mg base/mL, is the subject of NDA
19667, held by Novartis Pharmaceuticals Corporation. NDA
19667 was initially approved on October 21, 1988, and the EQ 0.2 mg base/mL and EQ 1 mg base/mL strengths were approved on June 12, 1991.
SANDOSTATIN is indicated to reduce blood levels of growth hormone and IGFI somatomedin C in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses.
SANDOSTATIN is also indicated for the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease.
SANDOSTATIN is also indicated for the treatment of profuse watery diarrhea associated with vasoactive intestinal peptide-secreting tumors.
In a letter received by the Agency on May 11, 2020, Novartis Pharmaceuticals Corporation notified FDA that
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SANDOSTATIN octreotide acetate injection, EQ 0.2 mg base/mL and EQ 1
mg base/mL, was being discontinued, and FDA moved the drug product to the Discontinued Drug Product List section of the Orange Book. Caplin Steriles Limited submitted a citizen petition dated February 5, 2021 Docket No. FDA2021P0163, under 21 CFR
10.30, requesting that the Agency determine whether SANDOSTATIN
octreotide acetate injection, EQ 0.2 mg base/mL and EQ 1 mg base/mL, was 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 314.161 that SANDOSTATIN
octreotide acetate injection, EQ 0.2 mg base/mL and EQ 1 mg base/mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that SANDOSTATIN
octreotide acetate injection, EQ 0.2 mg base/mL and EQ 1 mg base/mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of SANDOSTATIN octreotide acetate injection, EQ 0.2 mg base/mL and EQ 1
mg base/mL, 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 SANDOSTATIN
octreotide acetate injection, EQ 0.2 mg base/mL and EQ 1 mg base/mL, 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. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also 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.

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Dated: May 26, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202111575 Filed 6121; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Rural Health Care Coordination Program Performance Improvement and Measurement System Database, OMB No. 0906
0024Reinstate With Changes Health Resources and Services Administration HRSA, Department of Health and Human Services HHS.
ACTION: Notice.
AGENCY:

In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request ICR to the Office of Management and Budget OMB for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB.
OMB will accept further comments from the public during the review and approval period.
DATES: Comments on this ICR should be received no later than July 2, 2021.
ADDRESSES: Submit your comments, including the ICR Title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202 3955806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call 301 4431984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference.
Information Collection Request Title:
Rural Health Care Coordination Program Performance Improvement and Measurement System Database, OMB
No. 09060024Reinstate with Changes.
Abstract: The Rural Health Care Coordination Care Coordination program is authorized under Section 330Ae of the Public Health Service PHS Act 42 U.S.C. 254e, as amended, to improve access and SUMMARY:

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