82 FR 49832 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 207 (October 27, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 207 (October 27, 2017)
| Page Range | 49832-49834 | |
| FR Document | 2017-23444 |
[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)] [Notices] [Pages 49832-49834] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23444] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1076] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection in the guidance on ``Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice.'' DATES: Submit either electronic or written comments on the collection of information by December 26, 2017. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 26, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 26, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2014-N-1076 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites [[Page 49833]] comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice OMB Control Number 0910-0563--Extension This information collection supports the guidance for industry on ``Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice.'' The guidance is available at: https://www.fda.gov/downloads/drugs/guidances/ucm070279.pdf. The guidance informs manufacturers of veterinary and human drugs, including human biological drug products, on how to resolve disputes about scientific and technical issues relating to current good manufacturing practice (CGMP). Disputes related to scientific and technical issues may arise during FDA inspections of pharmaceutical manufacturers to determine compliance with CGMP requirements or during FDA's assessment of corrective actions undertaken as a result of such inspections. The guidance provides procedures that encourage open and prompt discussion of disputes and lead to their resolution. The guidance describes procedures for raising such disputes to the Office of Regulatory Affairs (ORA) and center levels and for requesting review by the dispute resolution (DR) panel. When a scientific or technical issue arises during an FDA inspection, the manufacturer should initially attempt to reach agreement on the issue informally with the investigator. Certain scientific or technical issues may be too complex or time consuming to resolve during the inspection. If resolution of a scientific or technical issue is not accomplished through informal mechanisms before the issuance of Form FDA 483, the manufacturer can formally request DR and use the two-tiered DR process described in the guidance. Tier one of the formal DR process involves a manufacturer raising scientific or technical issues to the ORA and center levels. If a manufacturer disagrees with the tier-one decision, tier two of the formal DR process would then be available for appealing that decision to the DR panel. The written request for formal DR to the appropriate ORA unit should be made within 30 days of the completion of an inspection and should include all supporting documentation and arguments for review, as described in this document. The written request for formal DR to the DR panel should be made within 60 days of receipt of the tier-one decision and should include all supporting documentation and arguments, as described in this document. All requests for formal DR should be submitted in writing and include adequate information to explain the nature of the dispute and to allow FDA to act quickly and efficiently. Each request should be sent to the appropriate address listed in the guidance and include the following elements: Cover sheet that clearly identifies the submission as either a tier-one or tier-two DR request. Name and address of manufacturer inspected (as listed on Form FDA 483). Date of inspection (as listed on Form FDA 483). Date Form FDA 483 was issued (as listed on Form FDA 483). Facility Establishment Identifier number, if available (as listed on Form FDA 483). Names and titles of FDA employees who conducted inspection (as listed on Form FDA 483). Office responsible for the inspection (e.g., district office, as listed on Form FDA 483). Application number if the inspection was a preapproval inspection. Comprehensive statement of each issue to be resolved: [cir] Identify the observation in dispute. [cir] Clearly present the manufacturer's scientific position or rationale concerning the issue under dispute with any supporting data. [cir] State the steps that have been taken to resolve the dispute, including any informal DR that may have occurred before the issuance of Form FDA 483. [cir] Identify possible solutions. [cir] State expected outcome. Name, title, telephone and fax numbers, and email address (as available) of manufacturer contact. The guidance responds to industry's request for a formal DR process to resolve differences related to scientific and technical issues that arise between investigators and pharmaceutical manufacturers during FDA inspections of foreign and domestic manufacturers. In addition to encouraging manufacturers to use currently available DR processes, the guidance describes the formal two-tiered DR process explained previously. The guidance also covers the following topics: Suitability of certain issues for the formal DR process, including examples, with a discussion of their appropriateness for the DR process. Instructions on how to submit requests for formal DR, and a list of the supporting information that should accompany these requests. Public availability of decisions reached during the DR process to promote consistent application and interpretation of regulations related to drug quality. We estimate the burden for the information collection as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Annual Activity Number of frequency per Total annual Average burden Total hours respondents response responses per response ---------------------------------------------------------------------------------------------------------------- Requests for tier-one DR........ 2 1 2 30 60 Requests for tier-two DR........ 1 1 1 8 8 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 68 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection. [[Page 49834]] As reflected in table 1, we estimate two manufacturers will submit two requests annually for tier-one DR, and that there will be one appeal of these requests to the DR panel (tier-two DR). We estimate also that it will take manufacturers approximately 30 hours to prepare and submit each request for a tier-one DR, and approximately 8 hours to prepare and submit each request for a tier-two DR. Based on our experience with this collection we have not changed our estimate since our last request for OMB approval. Dated: October 24, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-23444 Filed 10-26-17; 8:45 am] BILLING CODE 4164-01-P
![49832 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
[FR Doc. 2017–23447 Filed 10–26–17; 8:45 am] www.regulations.gov will be posted to the claimed confidential information, in
BILLING CODE 4120–01–C the docket unchanged. Because your its consideration of comments. The
comment will be made public, you are second copy, which will have the
solely responsible for ensuring that your claimed confidential information
DEPARTMENT OF HEALTH AND comment does not include any redacted/blacked out, will be available
HUMAN SERVICES confidential information that you or a for public viewing and posted on
third party may not wish to be posted, https://www.regulations.gov. Submit
Food and Drug Administration such as medical information, your or both copies to the Dockets Management
[Docket No. FDA–2014–N–1076] anyone else’s Social Security number, or Staff. If you do not wish your name and
confidential business information, such contact information to be made publicly
Agency Information Collection as a manufacturing process. Please note available, you can provide this
Activities; Proposed Collection; that if you include your name, contact information on the cover sheet and not
Comment Request; Guidance for information, or other information that in the body of your comments and you
Industry on Formal Dispute identifies you in the body of your must identify this information as
Resolution: Scientific and Technical comments, that information will be ‘‘confidential.’’ Any information marked
Issues Related to Pharmaceutical posted on https://www.regulations.gov. as ‘‘confidential’’ will not be disclosed
Current Good Manufacturing Practice • If you want to submit a comment except in accordance with 21 CFR 10.20
with confidential information that you and other applicable disclosure law. For
AGENCY: Food and Drug Administration, do not wish to be made available to the more information about FDA’s posting
HHS. public, submit the comment as a of comments to public dockets, see 80
ACTION: Notice. written/paper submission and in the FR 56469, September 18, 2015, or access
manner detailed (see ‘‘Written/Paper the information at: https://www.gpo.gov/
SUMMARY: The Food and Drug
Submissions’’ and ‘‘Instructions’’). fdsys/pkg/FR-2015-09-18/pdf/2015-
Administration (FDA or Agency) is
announcing an opportunity for public Written/Paper Submissions 23389.pdf.
comment on the proposed collection of Docket: For access to the docket to
Submit written/paper submissions as read background documents or the
certain information by the Agency. follows: electronic and written/paper comments
Under the Paperwork Reduction Act of • Mail/Hand delivery/Courier (for received, go to https://
1995 (PRA), Federal Agencies are written/paper submissions): Dockets
required to publish notice in the www.regulations.gov and insert the
Management Staff (HFA–305), Food and docket number, found in brackets in the
Federal Register concerning each Drug Administration, 5630 Fishers
proposed collection of information, heading of this document, into the
Lane, Rm. 1061, Rockville, MD 20852.
‘‘Search’’ box and follow the prompts
including each proposed extension of an • For written/paper comments
existing collection of information, and and/or go to the Dockets Management
submitted to the Dockets Management
to allow 60 days for public comment in Staff, FDA will post your comment, as Staff, 5630 Fishers Lane, Rm. 1061,
response to the notice. This notice well as any attachments, except for Rockville, MD 20852.
solicits comments on the information information submitted, marked and FOR FURTHER INFORMATION CONTACT:
collection in the guidance on ‘‘Formal identified, as confidential, if submitted Domini Bean, Office of Operations,
Dispute Resolution: Scientific and as detailed in ‘‘Instructions.’’ Food and Drug Administration, Three
Technical Issues Related to Instructions: All submissions received White Flint North, 10A–12M, 11601
Pharmaceutical Current Good must include the Docket No. FDA– Landsdown St., North Bethesda, MD
Manufacturing Practice.’’ 2014–N–1076 for ‘‘Agency Information 20852, 301–796–5733, PRAStaff@
DATES: Submit either electronic or Collection Activities; Proposed fda.hhs.gov.
written comments on the collection of Collection; Comment Request; Guidance SUPPLEMENTARY INFORMATION: Under the
information by December 26, 2017. for Industry on Formal Dispute PRA (44 U.S.C. 3501–3520), Federal
ADDRESSES: You may submit comments Resolution: Scientific and Technical Agencies must obtain approval from the
as follows. Please note that late, Issues Related to Pharmaceutical Office of Management and Budget
untimely filed comments will not be Current Good Manufacturing Practice.’’ (OMB) for each collection of
considered. Electronic comments must Received comments, those filed in a information they conduct or sponsor.
be submitted on or before December 26, timely manner (see ADDRESSES), will be ‘‘Collection of information’’ is defined
2017. The https://www.regulations.gov placed in the docket and, except for in 44 U.S.C. 3502(3) and 5 CFR
electronic filing system will accept those submitted as ‘‘Confidential 1320.3(c) and includes Agency requests
comments until midnight Eastern Time Submissions,’’ publicly viewable at or requirements that members of the
at the end of December 26, 2017. https://www.regulations.gov or at the public submit reports, keep records, or
Comments received by mail/hand Dockets Management Staff between 9 provide information to a third party.
delivery/courier (for written/paper a.m. and 4 p.m., Monday through Section 3506(c)(2)(A) of the PRA (44
submissions) will be considered timely Friday. U.S.C. 3506(c)(2)(A)) requires Federal
if they are postmarked or the delivery • Confidential Submissions—To Agencies to provide a 60-day notice in
service acceptance receipt is on or submit a comment with confidential the Federal Register concerning each
before that date. information that you do not wish to be proposed collection of information,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
made publicly available, submit your including each proposed extension of an
Electronic Submissions comments only as a written/paper existing collection of information,
Submit electronic comments in the submission. You should submit two before submitting the collection to OMB
following way: copies total. One copy will include the for approval. To comply with this
• Federal eRulemaking Portal: information you claim to be confidential requirement, FDA is publishing notice
https://www.regulations.gov. Follow the with a heading or cover note that states of the proposed collection of
instructions for submitting comments. ‘‘THIS DOCUMENT CONTAINS information set forth in this document.
Comments submitted electronically, CONFIDENTIAL INFORMATION.’’ The With respect to the following
including attachments, to https:// Agency will review this copy, including collection of information, FDA invites
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![49834 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
As reflected in table 1, we estimate White Flint North, 10A–12M, 11601 Evaluation of the Point of Sale
two manufacturers will submit two Landsdown St., North Bethesda, MD Campaign. This outcome evaluation
requests annually for tier-one DR, and 20852, 301–796–8867, PRAStaff@ study will consist of four longitudinal
that there will be one appeal of these fda.hhs.gov. data collection periods over 24 months
requests to the DR panel (tier-two DR). SUPPLEMENTARY INFORMATION: In (approximately every 7 months), with
We estimate also that it will take compliance with 44 U.S.C. 3507, FDA the first survey (Wave 1) occurring
manufacturers approximately 30 hours has submitted the following proposed approximately 3 months after campaign
to prepare and submit each request for collection of information to OMB for launch. A fourth wave of data collection
a tier-one DR, and approximately 8 has been added to the three proposed in
review and clearance.
hours to prepare and submit each the 60-day notice because the campaign
request for a tier-two DR. Based on our Evaluation of FDA’s Education at the has been extended from 18 to 24
experience with this collection we have Point of Sale Campaign OMB Control months. The additional wave of data
not changed our estimate since our last Number 0910—NEW collection is necessary to continue to
request for OMB approval. The 2009 Family Smoking Prevention assess the impact of the campaign. To
Dated: October 24, 2017. and Tobacco Control Act (Tobacco reduce the number of participants
Control Act) (Pub. L. 111–31) amends needed to detect the effects of the
Anna K. Abram,
the Federal Food, Drug, and Cosmetic campaign on outcomes of interest, the
Deputy Commissioner for Policy, Planning, design of the campaign was changed
Legislation, and Analysis. Act (the FD&C Act) to grant FDA
authority to regulate the manufacture, from two treatment groups and one
[FR Doc. 2017–23444 Filed 10–26–17; 8:45 am]
marketing, and distribution of tobacco control group to one treatment group
BILLING CODE 4164–01–P and one control group. The respondent
products to protect public health and to
numbers and burden hours below have
reduce tobacco use by minors. Section
been revised to reflect the four data
DEPARTMENT OF HEALTH AND 1003(d)(2)(D) of the FD&C Act (21
collection waves and the change in the
HUMAN SERVICES U.S.C. 393(d)(2)(D)) supports the
number of treatment groups.
development and implementation of Information will be collected from
Food and Drug Administration FDA public education campaigns adult cigarette smokers, ages 25 to 54,
[Docket No. FDA–2016–N–3710] related to tobacco use. Accordingly, about awareness of and exposure to
FDA is currently developing and campaign advertisements, tobacco use,
Agency Information Collection implementing a tobacco education and knowledge, attitudes, and beliefs
Activities; Submission for Office of intervention at the point of sale to related to tobacco use. Information will
Management and Budget Review; reduce the public health burden of be collected on demographic variables
Comment Request; Evaluation of the tobacco use. The campaign features including age, sex, race/ethnicity, and
Food and Drug Administration’s advertisements intended to encourage primary language. Participants will also
Education at the Point of Sale future quit attempts among current be offered the option to download a
Campaign smokers in stores that sell tobacco smartphone application that will track
products. their exposure to the campaign, and that
AGENCY: Food and Drug Administration, In support of the provisions of the
HHS. will ask them to respond to a brief
Tobacco Control Act that require FDA to survey about every 6 months over 18
ACTION: Notice. protect the public health, FDA requests months.
SUMMARY: The Food and Drug OMB approval to collect information to FDA’s media contractor identified 37
Administration (FDA) is announcing evaluate the effectiveness of the point of potential counties for the campaign.
that a proposed collection of sale tobacco education campaign. Data From this list, FDA’s evaluation
information has been submitted to the from this outcome evaluation study will contractor has selected 30 counties to be
Office of Management and Budget be used to examine statistical included in the evaluation. Of these, 15
(OMB) for review and clearance under associations between exposure to the counties will receive the intervention
the Paperwork Reduction Act of 1995. campaign and specific outcomes of (treatment counties), and 15 counties
interest, which include awareness of the will not receive it (control counties).
DATES: Fax written comments on the
campaign and its messaging, tobacco- The number of counties has changed
collection of information by November
related attitudes, beliefs and risk since the 60-day notice because we
27, 2017.
perceptions, and motivation to quit changed the experimental design to
ADDRESSES: To ensure that comments on smoking. have one treatment group instead of
the information collection are received, Evaluation is an essential two, which resulted in needing fewer
OMB recommends that written organizational practice in public health counties.
comments be faxed to the Office of and a systematic way to account for and Data will be collected from a
Information and Regulatory Affairs, improve public health actions. longitudinal cohort that will consist of
OMB, Attn: FDA Desk Officer, Fax: 202– Comprehensive evaluation of FDA’s an entirely new sample of adult
395–7285, or emailed to oira_ public education campaigns will be cigarette smokers. Addresses will be
submission@omb.eop.gov. All used to document whether the intended randomly selected from postal carrier
comments should be identified with the audience is aware of and understands routes in the 30 selected U.S. counties
OMB control number 0910—NEW and
asabaliauskas on DSKBBXCHB2PROD with NOTICES
campaign messages, and whether to identify households that contain one
title ‘‘Evaluation of FDA’s Education at campaign exposure influences tobacco- or more adult smokers between the ages
the Point of Sale Campaign.’’ Also, related attitudes, beliefs and risk of 25 and 54. Pre-paid pre-addressed
include the FDA docket number found perceptions, intentions to use tobacco, paper screening surveys will be mailed
in brackets in the heading of this and motivation to quit smoking. to approximately 104,541 households.
document. Participation in the outcome evaluation We estimate that 27,651 (9,217
FOR FURTHER INFORMATION CONTACT: study will be voluntary. All of the annualized respondents) households
Amber Sanford, Office of Operations, information collected is integral to that will return the 10-minute screener they
Food and Drug Administration, Three evaluation. received by mail, and 26,258 (8,753
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Document Created: 2017-10-27 02:06:07
Document Modified: 2017-10-27 02:06:07
| 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 | Submit either electronic or written comments on the collection of information by December 26, 2017. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 82 FR 49832 |
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