80 FR 38211 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Controlled Correspondence Related to Generic Drug Development
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 127 (July 2, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 127 (July 2, 2015)
| Page Range | 38211-38212 | |
| FR Document | 2015-16358 |
[Federal Register Volume 80, Number 127 (Thursday, July 2, 2015)] [Notices] [Pages 38211-38212] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-16358] [[Page 38211]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-1167] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Controlled Correspondence Related to Generic Drug Development AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by August 3, 2015. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected]. All comments should be identified with the title. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Guidance for Industry on Controlled Correspondence Related to Generic Drug Development OMB Control Number 0910-NEW In the Federal Register of August 27, 2014 (79 FR 51180), FDA announced the availability of a draft guidance for industry entitled ``Controlled Correspondence Related to Generic Drug Development.'' The draft guidance provided information regarding the process by which human generic drug manufacturers and related industry can submit correspondence to FDA requesting information on generic drug development. This guidance also described FDA's process for providing communications related to such correspondence. On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) were signed into law by the President to speed the delivery of safe and effective generic drugs to the public and to reduce costs to industry. Under GDUFA, FDA agreed to certain obligations as laid out in the GDUFA Commitment Letter that accompanies the legislation (Ref. 1). The GDUFA Commitment Letter described controlled correspondence as follows: ``FDA's Office of Generic Drugs provides assistance to pharmaceutical firms and related industry regarding a variety of questions posed as `controlled documents.' See http://www.fda.gov/AboutFDA/CentersOffices/officeofmedicalproductsandtobacco/CDER/ucm120610.htm (Ref. 2). Controlled correspondence does not include citizen petitions, petitions for reconsideration, or requests for stay.'' The draft guidance is intended to further refine this description to best support the aims identified in the GDUFA Commitment Letter of ensuring the safety of generic drug products; enhancing access by expediting the availability of these products; and enhancing transparency by, among other things, improving FDA's communications and feedback with industry in order to expedite product access. In addition, this guidance provides detail and recommendations concerning what inquiries FDA considers as controlled correspondence for the purposes of meeting the Agency's GDUFA commitment, what information requestors can include in a controlled correspondence to facilitate FDA's consideration of and response to a controlled correspondence, and what information FDA will provide in its communications to entities that have submitted a controlled correspondence. Under GDUFA, FDA has agreed to specific program enhancements and performance goals specified in the GDUFA Commitment Letter. One of the performance goals applies to controlled correspondence related to generic drug development. The Commitment Letter includes details on FDA's commitment to respond to questions submitted as controlled correspondence within certain time frames. To facilitate FDA's prompt consideration of the controlled correspondence and response, and to assist in meeting the prescribed time frames, FDA recommends including the following information in the inquiry: (1) Name, title, address, phone number, and entity of the person submitting the inquiry; (2) an email address; (3) an FDA-assigned control number and submission date of any previous related correspondence, if applicable; (4) the relevant reference listed drug, as applicable, including the application number, proprietary (brand) name, manufacturer, active ingredient, dosage form, and strength(s); (5) a concise statement of the inquiry; (6) a recommendation of the appropriate FDA review discipline; and (7) relevant prior research and supporting materials. In the Federal Register of August 27, 2014 (79 FR 51180), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received several comments pertaining to the scope of controlled correspondence. We summarize the comments and provide our response below: (Comment) Several comments expressed concern related to three types of requests that FDA proposed to exclude from the definition of controlled correspondence. The three exclusions are: (1) Requests for recommendations on the appropriate design of bioequivalence (BE) studies for a specific drug product (BE guidance requests); (2) requests for review of BE clinical protocols (clinical protocol requests); and (3) requests for meetings to discuss generic drug development prior to ANDA submission (pre-ANDA meeting requests). (Response) FDA has not changed its policy regarding its consideration of requests for bioequivalence guidance, clinical protocol reviews, and pre-ANDA meetings. FDA will consider them promptly upon their electronic submission and will respond as expeditiously as practicable. Although the guidance states that these requests are not considered controlled correspondence submissions, requests for BE guidance and pre-ANDA meetings are included in the 1,020 total annual responses estimated in table 1 because these requests will utilize the same information collection pathway as a request that is considered controlled correspondence. For reasons described in the draft guidance, however, controlled correspondence GDUFA metrics will not apply to FDA's responses to the three excluded requests. The following information is based on inquiries considered controlled correspondence and submitted to FDA for FYs 2011, 2012, and 2013. FDA estimates approximately 217 generic drug manufacturers and related industry (e.g., contract research organizations conducting bioanalytical or bioequivalence clinical trials) or their representatives would each submit an average of 4.7 inquiries annually for a [[Page 38212]] total of 1,020 inquiries (1,020 / 217 = 4.7). Information submitted with each inquiry varies widely in content, depending on the complexity of the request. Inquiries that are defined as controlled correspondence (i.e., inquiries that request information on a specific element of generic drug product development) may range from a simple inquiry on generic drug labeling to a more complex inquiry for a formulation assessment for a specific proposed generic drug product. As a result, these inquiries can vary between 1 to 10 burden hours, respectively. Because the content of inquiries considered controlled correspondence is widely varied, we are providing an average burden hour for each inquiry. We estimate that it will take an average of 5 hours per inquiry for industry to gather necessary information, prepare the request, and submit the request to FDA. As a result, we estimate that it will take an average of 5,100 total hours annually for industry to prepare and submit inquiries considered controlled correspondence. Description of Respondents: Respondents are human generic drug manufacturers and related industry. Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Submission of controlled correspondence Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Manufacturers, Related Industry, and Representatives............... 217 4.7 1,020 5 5,100 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. References 1. ``Generic Drug User Fee Act Program Performance Goals and Procedures'' (GDUFA Commitment Letter) for fiscal years 2013 through 2017, available at http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf). 2. Id. at p. 15. The Web page quoted in the controlled correspondence definition has been updated as the link provided in the GDUFA Commitment Letter is no longer accessible. Dated: June 26, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-16358 Filed 7-1-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 127 / Thursday, July 2, 2015 / Notices 38211
DEPARTMENT OF HEALTH AND described FDA’s process for providing submission date of any previous related
HUMAN SERVICES communications related to such correspondence, if applicable; (4) the
correspondence. relevant reference listed drug, as
Food and Drug Administration On July 9, 2012, the Generic Drug applicable, including the application
User Fee Amendments of 2012 (GDUFA) number, proprietary (brand) name,
[Docket No. FDA–2014–D–1167]
were signed into law by the President to manufacturer, active ingredient, dosage
Agency Information Collection speed the delivery of safe and effective form, and strength(s); (5) a concise
Activities; Submission for Office of generic drugs to the public and to statement of the inquiry; (6) a
Management and Budget Review; reduce costs to industry. Under GDUFA, recommendation of the appropriate FDA
Comment Request; Guidance for FDA agreed to certain obligations as laid review discipline; and (7) relevant prior
Industry on Controlled out in the GDUFA Commitment Letter research and supporting materials.
Correspondence Related to Generic that accompanies the legislation (Ref. 1). In the Federal Register of August 27,
Drug Development The GDUFA Commitment Letter 2014 (79 FR 51180), FDA published a
described controlled correspondence as 60-day notice requesting public
AGENCY: Food and Drug Administration, follows: ‘‘FDA’s Office of Generic Drugs comment on the proposed collection of
HHS. provides assistance to pharmaceutical information. FDA received several
ACTION: Notice. firms and related industry regarding a comments pertaining to the scope of
variety of questions posed as ‘controlled controlled correspondence. We
SUMMARY: The Food and Drug documents.’ See http://www.fda.gov/ summarize the comments and provide
Administration (FDA) is announcing AboutFDA/CentersOffices/ our response below:
that a proposed collection of officeofmedicalproductsandtobacco/ (Comment) Several comments
information has been submitted to the CDER/ucm120610.htm (Ref. 2). expressed concern related to three types
Office of Management and Budget Controlled correspondence does not of requests that FDA proposed to
(OMB) for review and clearance under include citizen petitions, petitions for exclude from the definition of
the Paperwork Reduction Act of 1995. reconsideration, or requests for stay.’’ controlled correspondence. The three
DATES: Fax written comments on the The draft guidance is intended to exclusions are: (1) Requests for
collection of information by August 3, further refine this description to best recommendations on the appropriate
2015. support the aims identified in the design of bioequivalence (BE) studies
ADDRESSES: To ensure that comments on GDUFA Commitment Letter of ensuring for a specific drug product (BE guidance
the information collection are received, the safety of generic drug products; requests); (2) requests for review of BE
OMB recommends that written enhancing access by expediting the clinical protocols (clinical protocol
comments be faxed to the Office of availability of these products; and requests); and (3) requests for meetings
Information and Regulatory Affairs, enhancing transparency by, among other to discuss generic drug development
OMB, Attn: FDA Desk Officer, FAX: things, improving FDA’s prior to ANDA submission (pre-ANDA
202–395–7285, or emailed to communications and feedback with meeting requests).
industry in order to expedite product (Response) FDA has not changed its
oira_submission@omb.eop.gov. All
access. In addition, this guidance policy regarding its consideration of
comments should be identified with the
provides detail and recommendations requests for bioequivalence guidance,
title. Also include the FDA docket
concerning what inquiries FDA clinical protocol reviews, and pre-
number found in brackets in the
considers as controlled correspondence ANDA meetings. FDA will consider
heading of this document.
for the purposes of meeting the them promptly upon their electronic
FOR FURTHER INFORMATION CONTACT: FDA submission and will respond as
Agency’s GDUFA commitment, what
PRA Staff, Office of Operations, Food information requestors can include in a expeditiously as practicable. Although
and Drug Administration, 8455 controlled correspondence to facilitate the guidance states that these requests
Colesville Rd., COLE–14526, Silver FDA’s consideration of and response to are not considered controlled
Spring, MD 20993–0002, a controlled correspondence, and what correspondence submissions, requests
PRAStaff@fda.hhs.gov. information FDA will provide in its for BE guidance and pre-ANDA
SUPPLEMENTARY INFORMATION: In communications to entities that have meetings are included in the 1,020 total
compliance with 44 U.S.C. 3507, FDA submitted a controlled correspondence. annual responses estimated in table 1
has submitted the following proposed Under GDUFA, FDA has agreed to because these requests will utilize the
collection of information to OMB for specific program enhancements and same information collection pathway as
review and clearance. performance goals specified in the a request that is considered controlled
GDUFA Commitment Letter. One of the correspondence. For reasons described
Guidance for Industry on Controlled performance goals applies to controlled in the draft guidance, however,
Correspondence Related to Generic correspondence related to generic drug controlled correspondence GDUFA
Drug Development OMB Control development. The Commitment Letter metrics will not apply to FDA’s
Number 0910–NEW includes details on FDA’s commitment responses to the three excluded
In the Federal Register of August 27, to respond to questions submitted as requests.
2014 (79 FR 51180), FDA announced the controlled correspondence within The following information is based on
availability of a draft guidance for certain time frames. To facilitate FDA’s inquiries considered controlled
industry entitled ‘‘Controlled prompt consideration of the controlled correspondence and submitted to FDA
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Correspondence Related to Generic Drug correspondence and response, and to for FYs 2011, 2012, and 2013. FDA
Development.’’ The draft guidance assist in meeting the prescribed time estimates approximately 217 generic
provided information regarding the frames, FDA recommends including the drug manufacturers and related industry
process by which human generic drug following information in the inquiry: (1) (e.g., contract research organizations
manufacturers and related industry can Name, title, address, phone number, and conducting bioanalytical or
submit correspondence to FDA entity of the person submitting the bioequivalence clinical trials) or their
requesting information on generic drug inquiry; (2) an email address; (3) an representatives would each submit an
development. This guidance also FDA-assigned control number and average of 4.7 inquiries annually for a
VerDate Sep<11>2014 21:16 Jul 01, 2015 Jkt 235001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\02JYN1.SGM 02JYN1](https://thefederalregister.org/doc/80_FR_38338/page/1.svg)
![38212 Federal Register / Vol. 80, No. 127 / Thursday, July 2, 2015 / Notices
total of 1,020 inquiries (1,020 ÷ 217 = assessment for a specific proposed the request, and submit the request to
4.7). Information submitted with each generic drug product. As a result, these FDA. As a result, we estimate that it will
inquiry varies widely in content, inquiries can vary between 1 to 10 take an average of 5,100 total hours
depending on the complexity of the burden hours, respectively. annually for industry to prepare and
request. Inquiries that are defined as Because the content of inquiries submit inquiries considered controlled
controlled correspondence (i.e., considered controlled correspondence is correspondence.
inquiries that request information on a widely varied, we are providing an
specific element of generic drug product average burden hour for each inquiry. Description of Respondents:
development) may range from a simple We estimate that it will take an average Respondents are human generic drug
inquiry on generic drug labeling to a of 5 hours per inquiry for industry to manufacturers and related industry.
more complex inquiry for a formulation gather necessary information, prepare
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Submission of controlled correspondence responses per burden per Total hours
respondents responses
respondent response
Manufacturers, Related Industry, and Representatives ...... 217 4.7 1,020 5 5,100
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
References pramoxine, and hydrocortisone; and Labeling Compliance, Center for Drug
1. ‘‘Generic Drug User Fee Act Program against persons who manufacture or Evaluation and Research, Food and
Performance Goals and Procedures’’ cause the manufacture or distribution of Drug Administration, 10903 New
(GDUFA Commitment Letter) for such products in interstate commerce. Hampshire Ave., Bldg. 51, Rm. 5236,
fiscal years 2013 through 2017, These unapproved and misbranded Silver Spring, MD 20993–0002; 301–
available at http://www.fda.gov/ prescription drug products are marketed 796–3329 or email: Kathleen.Joyce@
downloads/ForIndustry/UserFees/ without evidence of safety and fda.hhs.gov.
GenericDrugUserFees/ effectiveness; may present safety FOR FURTHER INFORMATION CONTACT:
UCM282505.pdf). concerns; and pose a direct challenge to Kathleen Joyce, Division of Prescription
2. Id. at p. 15. The Web page quoted in the new drug approval system and, in Drugs, Office of Unapproved Drugs and
the controlled correspondence some cases, the over-the-counter (OTC) Labeling Compliance, Center for Drug
definition has been updated as the drug monograph system. Evaluation and Research, Food and
link provided in the GDUFA DATES: This notice is effective July 2, Drug Administration, 10903 New
Commitment Letter is no longer 2015. For information about Hampshire Ave., Bldg. 51, rm. 5236,
accessible. enforcement dates, see SUPPLEMENTARY Silver Spring, MD 20993–0002; 301–
INFORMATION, section IV. 796–3329 or email: Kathleen.Joyce@
Dated: June 26, 2015.
Leslie Kux, ADDRESSES: For all communications in fda.hhs.gov.
Associate Commissioner for Policy.
response to this notice, identify with SUPPLEMENTARY INFORMATION:
Docket No. FDA–2015–N–2008 and
[FR Doc. 2015–16358 Filed 7–1–15; 8:45 am] I. Background
direct to the appropriate office listed in
BILLING CODE 4164–01–P
this ADDRESSES section as follows: FDA is announcing its intention to
Applications under section 505(b) of take enforcement action against certain
the Federal Food, Drug, and Cosmetic unapproved and misbranded otic drug
DEPARTMENT OF HEALTH AND
Act (the FD&C Act) (21 U.S.C. 355(b)): products labeled for prescription use.
HUMAN SERVICES
Division of Anesthesia, Analgesia, and These marketed unapproved and
Food and Drug Administration Addiction Products (for drug products misbranded otic drug products are
with analgesic and anti-inflammatory labeled for, among other things, the
[Docket No. FDA–2015–N–2008] indications), or Division of Anti- temporary relief of pain associated with
Infective Drug Products (for drug ear infections or inflammation,
Unapproved and Misbranded Otic products with anti-infective including acute otitis media (middle ear
Prescription Drug Products; indications), Office of New Drugs, infection), otitis media with effusion
Enforcement Action Dates Center for Drug Evaluation and (fluid in the ear, but without infection),
AGENCY: Food and Drug Administration, Research, Food and Drug and acute otitis externa (infection in the
HHS. Administration, 10903 New Hampshire outer ear or ‘‘swimmer’s ear’’). Other
ACTION: Notice. Ave., Bldg. 22, Silver Spring, MD indications for these unapproved drug
20993–0002. products include anti-infective and anti-
SUMMARY: The Food and Drug Applications under section 505(j) of inflammatory claims, as well as claims
Administration (FDA or Agency) is the FD&C Act: Office of Generic Drugs, for the removal of cerumen (earwax).
announcing its intention to take Center for Drug Evaluation and This notice covers the following
asabaliauskas on DSK5VPTVN1PROD with NOTICES
enforcement action against unapproved Research, Food and Drug marketed unapproved prescription otic
and misbranded otic drug products Administration, 10903 New Hampshire drug products: (1) Single-ingredient otic
labeled for prescription use and Ave., Bldg. 75, Silver Spring, MD drug products containing benzocaine;
containing benzocaine; benzocaine and 20993–0002. (2) fixed-dose combination otic drug
antipyrine; benzocaine, antipyrine, and All other communications about this products containing benzocaine and
zinc acetate; benzocaine, chloroxylenol, action should be directed to: Kathleen antipyrine; (3) fixed-dose combination
and hydrocortisone; chloroxylenol and Joyce, Division of Prescription Drugs, otic drug products containing
pramoxine; or chloroxylenol, Office of Unapproved Drugs and benzocaine, antipyrine, and zinc
VerDate Sep<11>2014 21:16 Jul 01, 2015 Jkt 235001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\02JYN1.SGM 02JYN1](https://thefederalregister.org/doc/80_FR_38338/page/2.svg)
Document Created: 2015-12-15 13:14:52
Document Modified: 2015-12-15 13:14:52
| 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. | |
| Dates | Fax written comments on the collection of information by August 3, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 38211 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR