[Federal Register Volume 84, Number 40 (Thursday, February 28, 2019)]
[Rules and Regulations]
[Pages 6672-6673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03542]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 312 and 314
[Docket No. FDA-2019-N-0646]
Change of Address; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is amending
its regulations to reflect a change of address for the Center for Drug
Evaluation and Research's (CDER's) Office of Generic Drugs (OGD)
Document Room from Rockville, MD, to Beltsville, MD. This action is
being taken to ensure accuracy and clarity in the Agency's regulations.
[[Page 6673]]
DATES: This rule is effective April 1, 2019.
FOR FURTHER INFORMATION CONTACT: Jonathan Resnick, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-7997.
SUPPLEMENTARY INFORMATION: FDA is amending its regulations in parts 312
and 314 (21 CFR parts 312 and 314) to reflect a change of address for
CDER's OGD Document Room from Rockville, MD, to Beltsville, MD. The new
address is as follows: Central Document Room, Center for Drug
Evaluation and Research, Food and Drug Administration, 5901-B Ammendale
Rd., Beltsville, MD 20705-1266. This action is being taken to ensure
accuracy and clarity in the Agency's regulations.
Publication of this document constitutes final action on these
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has
determined that notice and public comment are unnecessary because this
amendment to the regulations provides only technical changes to update
a mailing address for those submissions not required to be submitted
through FDA's Electronic Submission Gateway. Unless granted a waiver or
exemption from the requirements of section 745A of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1), submissions under
section 505(j) of the FD&C Act (21 U.S.C. 355(j)) are required to be
submitted in electronic format.\1\
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\1\ See FDA guidance for industry entitled ``Providing
Regulatory Submissions in Electronic Format--Certain Human
Pharmaceutical Product Applications and Related Submissions Using
the eCTD Specifications'' (January 2019, Revision 6). We update
guidances periodically. For the most recent version of a guidance,
check the FDA guidance web page at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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The amendments are as follows:
In Sec. 312.140(a)(1), the address for applicants to
submit investigational new drug applications (INDs) for in vivo
bioavailability and bioequivalence studies to support abbreviated new
drug applications (ANDAs) is updated to the Beltsville Central Document
Room location.
In Sec. 314.52(a)(2), for 505(b)(2) applicants submitting
a patent certification, the address to send written or electronic
communication to obtain the address of a new drug application (NDA)
holder or its attorney, agent, or authorized official is updated to the
Beltsville Central Document Room location.
In Sec. 314.53(f)(1), the address for persons other than
the NDA holder to send patent listing dispute communication is updated
to the Beltsville Central Document Room location.
In Sec. 314.95(a)(2), for ANDA applicants submitting a
patent certification, the address to send written or electronic
communication to obtain the address of an NDA holder or its attorney,
agent, or authorized official is updated to the Beltsville Central
Document Room location.
In Sec. 314.440(a)(2), the address for applicants to
submit ANDAs, amendments, supplements, resubmissions, and
correspondence not associated with an ANDA is updated to the Beltsville
Central Document Room location.
List of Subjects
21 CFR Part 312
Drugs, Exports, Imports, Investigations, Labeling, Medical
research, Reporting and recordkeeping requirements, Safety.
21 CFR Part 314
Administrative practice and procedure, Confidential business
information, Drugs, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
312 and 314 are amended as follows:
PART 312--INVESTIGATIONAL NEW DRUG APPLICATION
0
1. The authority citation for part 312 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371;
42 U.S.C. 262.
0
2. In Sec. 312.140, revise paragraph (a)(1) to read as follows:
Sec. 312.140 Address for correspondence.
(a) * * *
(1) For drug products regulated by CDER. Send the IND submission to
the Central Document Room, Center for Drug Evaluation and Research,
Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD
20705-1266.
* * * * *
PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
0
3. The authority citation for part 314 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f,
356, 356a, 356b, 356c, 356e, 360cc, 371, 374, 379e, 379k-1.
Sec. 314.52 [Amended]
0
4. In Sec. 314.52(a)(2), remove the text ``Orange Book Staff, Office
of Generic Drugs, 7620 Standish Pl., Rockville, MD 20855'' and add in
its place the text ``Central Document Room, Attn: Orange Book Staff,
Center for Drug Evaluation and Research, Food and Drug Administration,
5901-B Ammendale Rd., Beltsville, MD 20705-1266''.
Sec. 314.53 [Amended]
0
5. In Sec. 314.53(f)(1), remove the text ``Office of Generic Drugs,
OGD Document Room, Attention: Orange Book Staff, 7620 Standish Pl.,
Rockville, MD 20855'' and add in its place the text ``Central Document
Room, Attn: Orange Book Staff, Center for Drug Evaluation and Research,
Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD
20705-1266''.
Sec. 314.95 [Amended]
0
6. In Sec. 314.95(a)(2), remove the text ``Orange Book Staff, Office
of Generic Drugs, 7620 Standish Pl., Rockville, MD 20855'' and add in
its place the text ``Central Document Room, Attn: Orange Book Staff,
Center for Drug Evaluation and Research, Food and Drug Administration,
5901-B Ammendale Rd., Beltsville, MD 20705-1266''.
0
7. In Sec. 314.440, revise paragraph (a)(2) to read as follows:
Sec. 314.440 Addresses for applications and abbreviated applications.
(a) * * *
(2) Except as provided in paragraph (a)(4) of this section, an
abbreviated application under Sec. 314.94, and amendments,
supplements, and resubmissions should be directed to the Central
Document Room, Center for Drug Evaluation and Research, Food and Drug
Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266. This
includes items sent by parcel post or overnight courier service.
Correspondence not associated with an abbreviated application also
should be addressed to 5901-B Ammendale Rd., Beltsville, MD 20705-1266.
* * * * *
Dated: February 22, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03542 Filed 2-27-19; 8:45 am]
BILLING CODE 4164-01-P